Hepatitis C Clinical Trial Updates For Aug 7th 2011

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Clinical trials

BI 201335 Used in Treatment Naive Patients Infected With Genotype 1 Chronic Hepatitis C Infection

Boehringer Ingelheim's experimental hepatitis C virus (HCV) protease inhibitor BI 201335

The objective of this trial is to evaluate the efficacy and safety of two different treatment regimens with BI 201335, both in combination with PegIFN/RBV) as compared to standard of care (SOC) with PegIFN/RBV alone.

A Phase III, Randomized, Double Blind and Placebo Controlled Study of Once Daily BI 201335 120 mg for 24 Weeks and BI 201335 240 mg for 12 Weeks in Combination With Pegylated Interferon Alpha and Ribavirin in Treatment Naive Patients With Genotype 1 Chronic Hepatitis C

Data on BI 201335 is available @ Hepatitis C New Drug Research and Liver Health

Boehringer Ingelheim Web Site

Boehringer Ingelheim Call CenterPhone: 1-800-243-0127
Email: clintriage.rdg@boehringer-ingelheim.com

49 Locations

1220.47.0045 Boehringer Ingelheim Investigational Site
Location: Birmingham, Alabama
1220.47.0004 Boehringer Ingelheim Investigational Site
Location: Birmingham, Alabama
1220.47.0050 Boehringer Ingelheim Investigational Site
Location: Dothan, Alabama
1220.47.0091 Boehringer Ingelheim Investigational Site
Location: Sherwood, Arkansas
1220.47.0008 Boehringer Ingelheim Investigational Site
Location: Bakersfield, California
1220.47.0019 Boehringer Ingelheim Investigational Site
Location: Chula Vista, California
1220.47.0010 Boehringer Ingelheim Investigational Site
Location: Coronado, California
1220.47.0035 Boehringer Ingelheim Investigational Site
Location: La Mesa, California
1220.47.0007 Boehringer Ingelheim Investigational Site
Location: Long Beach, California
1220.47.0011 Boehringer Ingelheim Investigational Site
Location: Los Angeles, California
1220.47.0100 Boehringer Ingelheim Investigational Site
Location: Los Angeles, California
1220.47.0014 Boehringer Ingelheim Investigational Site
Location: Los Angeles, California
1220.47.0018 Boehringer Ingelheim Investigational Site
Location: Oceanside, California
1220.47.0059 Boehringer Ingelheim Investigational Site
Location: Poway, California
1220.47.0037 Boehringer Ingelheim Investigational Site
Location: San Diego, California
1220.47.0005 Boehringer Ingelheim Investigational Site
Location:Washington, District of Columbia
1220.47.0057 Boehringer Ingelheim Investigational Site
Location: Bradenton, Florida
1220.47.0078 Boehringer Ingelheim Investigational Site
Location: Fort Lauderdale, Florida
1220.47.0086 Boehringer Ingelheim Investigational Site
Location: Fort Lauderdale, Florida
1220.47.0054 Boehringer Ingelheim Investigational Site
Location: Hialeah, Florida
1220.47.0044 Boehringer Ingelheim Investigational Site
Location: Orlando, Florida
1220.47.0099 Boehringer Ingelheim Investigational Site
Location: Orlando, Florida
1220.47.0095 Boehringer Ingelheim Investigational Site
Location: Palm Harbor, Florida
1220.47.0039 Boehringer Ingelheim Investigational Site
Location: Columbus, Georgia
1220.47.0052 Boehringer Ingelheim Investigational Site
Location: Decatur, Georgia
1220.47.0062 Boehringer Ingelheim Investigational Site
Location: Vaiparaiso, Indiana
1220.47.0085 Boehringer Ingelheim Investigational Site
Location: Baton Rouge, Louisiana
1220.47.0087 Boehringer Ingelheim Investigational Site
Location: Baton Rouge, Louisiana
1220.47.0064 Boehringer Ingelheim Investigational Site
Location: Baltimore, Maryland
1220.47.0067 Boehringer Ingelheim Investigational Site
Location: Chevy Chase, Maryland
1220.47.0065 Boehringer Ingelheim Investigational Site
Location: Springfield, Massachusetts
1220.47.0023 Boehringer Ingelheim Investigational Site
Location: Tulepo, Mississippi
1220.47.0046 Boehringer Ingelheim Investigational Site
Location: Las Vegas, Nevada
1220.47.0002 Boehringer Ingelheim Investigational Site
Location: Manhasset, New York
1220.47.0006 Boehringer Ingelheim Investigational Site
Location: New York, New York
1220.47.0098 Boehringer Ingelheim Investigational Site
Location: Tulsa, Oklahoma
1220.47.0058 Boehringer Ingelheim Investigational Site
Location: Portland, Oregon
1220.47.0030 Boehringer Ingelheim Investigational Site
Location: Germantown, Tennessee
1220.47.0072 Boehringer Ingelheim Investigational Site
Location: Jackson, Tennessee
1220.47.0041 Boehringer Ingelheim Investigational Site
Location: Nashville, Tennessee
1220.47.0063 Boehringer Ingelheim Investigational Site
Location: Arlington, Texas
1220.47.0029 Boehringer Ingelheim Investigational Site
Location: Austin, Texas
1220.47.0071 Boehringer Ingelheim Investigational Site
Location: Dallas, Texas
1220.47.0060 Boehringer Ingelheim Investigational Site
Location: Fort Worth, Texas
1220.47.0009 Boehringer Ingelheim Investigational Site
Location: Houston, Texas
1220.47.0016 Boehringer Ingelheim Investigational Site
Location: San Antonio, Texas
1220.47.0042 Boehringer Ingelheim Investigational Site
Location: Fairfax, Virginia
1220.47.0026 Boehringer Ingelheim Investigational Site
Location: Richmond, Virginia
1220.47.0073 Boehringer Ingelheim Investigational Site
Location: Milwaukee, Wisconsin

Safety, Antiviral Effect and PK of BI 207127 + BI 201335 +/- RBV for 4 up to 40 Weeks in Patients With Chronic HCV Genotype 1 Infection
The substances BI 201335 and BI 207127 are being developed for the treatment of chronic hepatitis C virus infection. BI 201335 and BI 207127 work by preventing the virus from replicating.
The currently available medications pegylated interferon alfa and ribavirin for hepatitis C ca have considerable adverse events in patients and in many cases are not sufficiently effective. This is particularly the case in treatment of patients infected with genotype 1 of HCV.
A combination therapy of these new substances without pegylated interferon alfa may be associated with fewer adverse events that currently available (pegylated interferon-alfa-based) medication and may also provide a treatment option to the large number of patients with contraindications or intolerance to pegylated interferon alfa.
Locations; France, Germany, Portugal, Spain and Switzerland...
View all locations here

Study of BMS-650032 With Peginterferon Alfa-2a Plus Ribavirin
Bristol-Myers Squibb - BMS-650032 is a NS3 protease inhibitor
The purpose of this study is to identify one or more doses of BMS-650032 that, when used in combination with pegylated-interferon alpha and ribavirin are safe and demonstrate sufficient activity against hepatitis C virus (Genotypes 1 and 4).

A Phase 2a/2b Study of BMS-650032 in Combination With Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment-Naive Subjects With Genotypes 1 and 4 Chronic Hepatitis C Infection

Pharmaceutical Company- Bristol-Myers Squibb

14 locations

The Research Institute
Location: Springfield, Massachusetts 01105
Umass Memorial Medical Center
Location: Worcester, Massachusetts 01655
James J Peters Vamc
Location: Bronx, New York 10468
Hospital Of The University Of Pennsylvania
Location: Philadelphia, Pennsylvania 19104
Mercy Medical Center
Location: Baltimore, Maryland 21202
Metropolitan Research
Location: Fairfax, Virginia 22031
University Of North Carolina, Chapel Hill
Location: Chapel Hill, North Carolina 27599
Florida Hospital Transplant Center
Location: Orlando, Florida 32804
University Of Alabama At Birmingham
Location: Birmingham, Alabama 35294
Alabama Liver & Digestive Specialists (Alds)
Location: Montgomery, Alabama 36116
Gastro One
Location: Germantown, Tennessee 38138
Dean Clinic
Location: Madison, Wisconsin 53715
Healthcare Research Consultants
Location: Tulsa, Oklahoma 74135
Oregon Health Science Univ
Location: Portland, Oregon 97239

International Locations; France, Germany, Ireland, Italy, United Kingdom, view all locations here

TMC435-TiDP16-C216 - Phase III Trial of TMC435 in Treatment-naive, Genotype 1 Hepatitis C-infected Patients

Medivir is a Sweden-based with the companies key pipeline asset, TMC435, a protease inhibitor, is in phase 2b clinical development for Hepatitis C and is partnered with Tibotec Pharmaceuticals, a Johnson & Johnson group company.

TMC435 is a selective small molecule inhibitor of the viral NS3/4A protease. It is currently being evaluated in HCV genotype-1 infected patients.

The purpose of this study is to investigate the effectiveness and safety of TMC435 compared with placebo in patients who are infected with genotype 1 hepatitis C virus who have never received treatment before. Patients will also receive peginterferon alfa-2a or peginterferon alfa-2b and ribavirin as part of their treatment.

Phase III, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety, and Tolerability of TMC435 vs Placebo as Part of a Treatment Regimen Including Peginterferon a-2a and Ribavirin or Peginterferon a-2b and Ribavirin in Treatment-naive

Pharmaceutical Company TMC435 is being jointly developed by Medivir and its partner Tibotec

11 locations

Study Name Unavailable
Location: Los Angeles, California
Study Name Unavailable
Location: Jacksonville, Florida
Study Name Unavailable
Location: Orlando, Florida
Study Name Unavailable
Location: Florence, Kentucky
Study Name Unavailable
Location: New Orleans, Louisiana
Study Name Unavailable
Location: Lutherville, Maryland
Study Name Unavailable
Location: Saint Paul, Minnesota
Study Name Unavailable
Location: Germantown, Tennessee
Study Name Unavailable
Location: Houston, Texas
Study Name Unavailable
Location: San Antonio, Texas
Study Name Unavailable
Location: Falls Church, Virginia

TMC435-TiDP16-C208 - Phase III Trial of TMC435 in Treatment-naive, Genotype 1 Hepatitis C-infected Patients

The purpose of this study is to investigate the effectiveness and safety of TMC435 compared with placebo in patients who are infected with genotype 1 hepatitis C virus who have never received treatment before. Patients will also receive peginterferon alfa-2a and ribavirin as part of their treatment.

A Phase III, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety, and Tolerability of TMC435 vs. Placebo as Part of a Treatment Regimen Including Peginterferon Alfa-2a and Ribavirin in Treatment-naive, Genotype 1 Hepatitis C

22 locations

Study Name Unavailable
Location: Birmingham, Alabama
Study Name Unavailable
Location: Dothan, Alabama
Study Name Unavailable
Location: Phoenix, Arizona
Study Name Unavailable
Location: Bakersfield, California
Study Name Unavailable
Location: Coronado, California
Study Name Unavailable
Location: Long Beach, California
Study Name Unavailable
Location: San Diego, California
Study Name Unavailable
Location: Aurora, Colorado
Study Name Unavailable
Location: Englewood, Colorado
Study Name Unavailable
Location: Miami, Florida
Study Name Unavailable
Location: Chicago, Illinois
Study Name Unavailable
Location: Jackson, Mississippi
Study Name Unavailable
Location: Tupelo, Mississippi
Study Name Unavailable
Location: Saint Louis, Missouri
Study Name Unavailable
Location: New York, New York
Study Name Unavailable
Location: Chapel Hill, North Carolina
Study Name Unavailable
Location: Cincinnati, Ohio
Study Name Unavailable
Location: Philadelphia, Pennsylvania
Study Name Unavailable
Location: Nashville, Tennessee
Study Name Unavailable
Location: Dallas, Texas
Study Name Unavailable
Location: Houston, Texas
Study Name Unavailable
Location: San Antonio, Texas

TMC435HPC3007 - Phase III Trial of TMC435 in Genotype 1 Hepatitis C-infected Patients Who Relapsed After Previous Therapy

The purpose of this study is to investigate the effectiveness and safety of TMC435 compared with placebo in patients who are infected with genotype 1 hepatitis C virus who relapsed after previous interferon-based therapy. Patients will also receive peginterferon alfa-2a and ribavirin as part of their treatment.

Phase III, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety and Tolerability of TMC435 vs. Placebo as Part of a Treatment Regimen Including Peginterferon Alfa-2a and Ribavirin in Hepatitis C Genotype 1 Infected Subjects

10 locations

Study Name Unavailable
Location: Bakersfield, California
Study Name Unavailable
Location: Aurora, Colorado
Study Name Unavailable
Location: Jacksonville, Florida
Study Name Unavailable
Location: Orlando, Florida
Study Name Unavailable
Location: Florence, Kentucky
Study Name Unavailable
Location: Saint Paul, Minnesota
Study Name Unavailable
Location: Jackson, Mississippi
Study Name Unavailable
Location: Germantown, Tennessee
Study Name Unavailable
Location: Houston, Texas
Study Name Unavailable
Location: San Antonio, Texas

TMC435-TiDP16-C113: A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics of TMC435

A Phase I, Open-label, Sequential Trial to Investigate the Pharmacokinetics, Safety, and Tolerability of TMC435 in Subjects With Moderately or Severely Impaired Hepatic Function

The purpose of the study is to investigate the effect of moderate and severe hepatic impairment on the pharmacokinetics of TMC435. Pharmacokinetics means how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body. In addition, the short-term safety and tolerability of TMC435 in participants with hepatic impairment will be determined. The results of this study will guide dose recommendations for TMC435 in patients with impaired liver function.

3 locations

Study Name Unavailable
Location: Anaheim, California
Study Name Unavailable
Location: Orlando, Florida
Study Name Unavailable
Location: San Antonio, Texas

INCIVEK-Telaprevir

Incivek is marketed by Vertex Pharmaceuticals a NS3/4A protease inhibitor
The U.S. Food and Drug Administration approved Incivek (telaprevir) to treat certain adults with chronic hepatitis C infection. Incivek is used for patients who have either not received interferon-based drug therapy for their infection or who have not responded adequately to prior therapies. Incivek is approved for use with interferon therapy made up of peginterferon alfa and ribavirin.

Pharmaceutical Web Site Vertex

Intrahepatic HCV RNA and Telaprevir Kinetics in Hepatitis C Virus (HCV)
The purpose of this study is to determine the decline of virus in the blood and liver in patients treated with telaprevir, pegylated interferon and ribavirin. Fine Needle Aspiration (FNA) procedure will be used to repeatedly sample the liver to enhance the understanding of how the virus decays in the liver in response to treatment with anti-viral compounds and the measurement of the concentration of the drugs in the liver. FNA is an alternative procedure to core needle biopsy in its ability to repeatedly sample the liver with significantly reduced morbidity.

#0810010040: Intrahepatic HCV RNA and Telaprevir Kinetics in Hepatitis C Virus Infection: A Study of Telaprevir in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects With Hepatitis C

1 Location

Weill Cornell Medical College
Location: New York, New York 10065

VX-222-INCIVEK

Related; Four Drug Combo VX-222, INCIVEK, Peg/Riba: Interim results from Vertex on their trial deemed, ZENITH

VX-222 Non-nucleoside Polymerase inhibitor (from ViroChem Pharma)

A Safety and Efficacy Study of the Combination of VX-222 and Telaprevir in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Virus Infection

The purpose of this study is to assess the safety and efficacy of combination treatment with VX-222 and telaprevir administered for 12 weeks with and without peginterferon-alfa-2a and/or ribavirin. The subjects enrolled in this study are chronically infected with hepatitis C virus (HCV) genotype 1 and will not have previously received treatment for their HCV infection. This study will include an Investigational Phase and Extension Phase. These phases will contain a Treatment Period and a Follow-up Period. All subjects will be enrolled in the Investigational Phase of this study. Subjects who fail treatment during the Investigational Phase will have the option to enter the Extension Phase at which point they will be eligible to receive peginterferon alfa-2a and ribavirin for a total of 48 weeks. Based on an evaluation of on-treatment safety, pharmacokinetic and antiviral data from patients in each arm of the trial, Vertex may elect to enroll up to two additional treatment arms (Treatment Arm E and Treatment Arm F) that will evaluate telaprevir/VX-222-based combination therapy. The components of the treatment regimens of these arms will be selected based on clinical data that emerges from the four initially-studied regimens. If enacted, up to 25 patients are expected to enroll in each additional treatment arm. If Treatment Arm E or Treatment Arm F is discontinued subjects meeting certain criteria will have the option to enter a telaprevir-containing Rollover Phase. Subjects who do not meet the eligibility criteria to enter the Rollover Phase may elect to enter the Extension Phase.

Randomized, Parallel-Group, Dose-Ranging Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Antiviral Activity of VX-222 and Telaprevir in Combination With and Without Peginterferon-Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Treatment-Naïve

13 locations

Study Name Unavailable
Location: La Jolla, California
Study Name Unavailable
Location: Aurora, Colorado
Study Name Unavailable
Location: Atlanta, Georgia
Study Name Unavailable
Location: Marietta, Georgia
Study Name Unavailable
Location: Lutherville, Maryland
Study Name Unavailable
Location: St. Louis, Missouri
Study Name Unavailable
Location: New York, New York
Study Name Unavailable
Location: Durham, North Carolina
Study Name Unavailable
Location: Cincinnati, Ohio
Study Name Unavailable
Location: Providence, Rhode Island
Study Name Unavailable
Location: Germantown, Tennessee
Study Name Unavailable
Location: Arlington, Texas
Study Name Unavailable
Location: San Antonio, Texas

Virology Follow up Study in Subjects Previously Treated With Telaprevir
Observational follow-up study to assess long-term response to telaprevir and to evaluate changes in Hepatitis C virus over time.

EXTEND: A 3-Year, Virology Follow up Study in Subjects Previously Treated With Telaprevir in Select Clinical Studies

25 locations

Alabama Location: Birmingham, Alabama
California Location: Coronado, California
California Location: Los Angeles, California
California Location: San Francisco, California
Colorado Location: Denver, Colorado
Colorado Location: Englewood, Colorado
Florida Location: Gainsville, Florida
Florida Location: Jacksonville, Florida
Florida Location: Miami, Florida
Georgia Location: Altanta, Georgia
Maryland Location: Baltimore, Maryland
Massachusetts Location: Boston, Massachusetts
Michigan Location: Novi, Michigan
Missouri Location: St. Louis, Missouri
New Mexico Location: Albuquerque, New Mexico
New York Location: Manhasset, New York
New York Location: New York, New York
North Carolina Location: Chapel Hill, North Carolina
North Carolina Location: Durham, North Carolina
Ohio Location: Cincinnati, Ohio
South Carolina Location: Columbia, South Carolina
Texas Location: Houston, Texas
Texas Location: San Antonio, Texas
Virginia Location: Fairfax, Virginia
Virginia Location: Falls Church, Virginia

A Study on The Combination of RO5024048 And Ritonavir-Boosted Danoprevir With And Without Copegus (Ribavirin) in Interferon-Naïve Patients With Chroni

In October 2010 Roche acquired the rights to InterMune HCV Protease Inhibitor Danoprevir.
Danoprevir protease inhibitor danoprevir (previously known as ITMN-191 or RG7227) is a second generation protease inhibitor for hepatitis C. In clinical trials, danoprevir has demonstrated strong early efficacy against the hepatitis C virus as a monotherapy, in combination with RG7128 and when combined with Pegasys and Copegus (ribavirin).
R7128 also known as (RO5024048) is a Nucleoside Polymerase Inhibitor. Ritonavir-is in a class of antiviral medications called protease inhibitors. Ritonavir as a (boosting agent). Ritonavir boosting is an option to enhance and improve pharmacokinetic profiles of protease inhibitors. It is well established in the treatment of HIV where it leads to more convenient dosing, reduced resistance development and high efficacy.

Data on Danoprevir is available @ Hepatitis C New Drugs Research and Liver Health

Related; From HCV New Drugs Pipeline- Hoffmann-La Roche trial status
R7128 (RO5024048) Nucleoside Polymerase Inhibitor plus ITMN-191 R7227 (RO5190591) Protease inhibitor

This multicenter, randomized, double-blind, parallel group study will evaluate the safety and efficacy of the combination RO5024048 and ritonavir-boosted danoprevir with and without Copegus (ribavirin) in patients with chronic hepatitis C genotype 1 who are treatment-naïve for interferons. Patients will receive 1000 mg RO5024048 orally twice daily and 100 mg danoprevir with 100 mg ritonavir orally twice daily plus either Copegus (1000 mg or 1200 mg orally daily) or placebo for 12 weeks. Depending on viral response, the assigned treatment will be continued for a further 12 weeks. The anticipated time on study treatment is up to 24 weeks plus a 24-week follow-up.

3 Locations

Study Name Unavailable
Location: Chicago, Illinois 60637
Study Name Unavailable
Location: Sacramento, California 95817
Study Name Unavailable
Location: Vancouver, Washington 98664

A Study of Danoprevir/Ritonavir and Copegus With RO5024048 and/or Pegasys in Patients With Chronic Hepatitis C
This randomized, open-label, multi-center study will evaluate the sustained virological response, pharmacokinetics and safety of various combinations of danoprevir/ritonavir with Copegus plus RO5024048 and/or Pegasys in patients with chronic hepatitis C infection. Patients will be divided into 2 separate cohorts. Cohort A, previous partial responders, will be randomized to Groups 1-3 and cohort B, previous null responders, will be randomized to Groups 4-6. Patients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. In addition, Groups 1 and 4 will receive RO5024048 1000 mg twice a day and Copegus 1000 mg or 1200 mg twice a day for 24 weeks; Group 2 will receive Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks; Groups 3, 5 and 6 will receive RO5024048 1000 mg twice a day, Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks. In addition, patients in Group 6 will receive another 24 weeks of Pegasys plus Copegus treatment.

A Randomized Open-label Study to Evaluate the Sustained Virologic Response of Danoprevir/Ritonavir and Copegus in Combination With RO5024048 and/or Pegasys in Chronic Hepatitis C Genotype 1 Patients Who Failed Previous Standard Therapy

7 locations

Study Name Unavailable
Location: Providence, Rhode Island 02905
Study Name Unavailable
Location: Nashville, Tennessee 37211
Study Name Unavailable
Location: Long Beach, California 90822
Study Name Unavailable
Location: San Diego, California 92103
Study Name Unavailable
Location: Aurora, Colorado 80045
Study Name Unavailable
Location: Medford, Oregon 97504
Study Name Unavailable
Location: San Antonio, Texas 78215

PSI-7977 With Pegylated Interferon and Ribavirin Hepatitis C Virus (HCV) Genotypes 1,4,5,6
Company Pharmasset- PSI-7977 is a Pyrimidine nucleotide polymerase inhibitor
The purpose of this study is to assess the safety, tolerability, and efficacy of PSI-7977 administered in combination with pegylated interferon and ribavirin (PEG/RBV) in treatment naive patients with HCV genotypes 1,4,5,6, or indeterminate genotype.

The ATOMIC Study: A Multicenter, Open-label, Randomized, Duration Finding Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Oral Administration of PSI-7977 in Combination With Pegylated Interferon and Ribavirin

Pharmaceutical Web Site Pharmasset

38 locations

Beth Israel Deconess Medical Center
Location: Boston, Massachusetts 02215
Concorde Medical Group
Location: New York, New York 10016
North Shore University Hospital
Location: Manhasset, New York 11303
Clinical Associates Research
Location: Reisterstown, Maryland 21136
Investigative Clinical Research
Location: Annapolis, Maryland 21401
Digestive and Liver Disease Specialist
Location: Norfolk, Virginia 23502
Asheville Gastroenterology Associates
Location: Asheville, North Carolina 28801
Columbia Gastroenterology Associates
Location: Columbia, South Carolina 29204
Gastrointestinal Specialists of Georgia
Location: Marietta, Georgia 30060
Atlanta Gastroenterology Associates
Location: Atlanta, Georgia 30308
University of Florida College of Medicine
Location: Gainesville, Florida 32610
Avail Clinical Research
Location: Deland, Florida 32720
Orlando Immunology Center
Location: Orlando, Florida 32803
Internal Medicine Specialists
Location: Orlando, Florida 32806
South Florida Center of Gastroenterology
Location: Wellington, Florida 33414
Pointe West Infectious Disease
Location: Bradenton, Florida 34209
Advanced Research Institute
Location: Trinity, Florida 34655
Alabama Liver and Digestive Specialist
Location: Montgomery, Alabama 36116
University of Cincinnati
Location: Cincinnati, Ohio 45267
Henry Ford Health System
Location: Novi, Michigan 48377
University of Chicago Medical Center
Location: Chicago, Illinois 60637
St. Louis University Gastroenterology and Hepatology Clinical Research
Location: St. Louis, Missouri 63104
Clopton Clinic
Location: Jonesboro, Arkansas 72401
North Texas Research Institute
Location: Arlington, Texas 76012
Baylor/ St. Luke's Advanced Liver Therapy
Location: Houston, Texas 77030
Alamo Medical Research
Location: San Antonio, Texas 78215
Central Texas Cinical Research
Location: Austin, Texas 78705
University of Colorado Denver Transplant Center and Hepatology Clinic
Location: Aurora, Colorado 80045
South Denver Gastreoenterology
Location: Englewood, Colorado 80110
University of New Mexico Health Science Center
Location: Albuquerque, New Mexico 87131
Cedars Sinai Medical Center
Location: Los Angeles, California 90048
eStudy Site
Location: Oceanside, California 92056
Desta Digestive Disease Medical Center
Location: San Diego, California 92114
Southern California Liver Centers
Location: Coronado, California 92118
Medical Associates Reseach Group
Location: San Diego, California 92123
Kaiser Permanente Hepatology Research
Location: San Diego, California 92154
Advanced Clinical Research Institute
Location: Anaheim, California 92801
Virginia Mason Medical Center
Location: Seattle, Washington 98101

Open-Labeled Study of PSI-7977 and RBV With and Without PEG-IFN in Treatment-Naïve Patients With HCV GT2 or GT3
To assess safety and tolerability of PSI-7977 400 mg with and without ribavirin (RBV) with and without pegylated interferon alfa 2a (PEG-IFN) in treatment naive subjects with hepatitis C (HCV) genotypes 2 or 3, and in HCV genotype 1 patients who are null-responders

Pharmasset Announced The Expansion of the ELECTRON trial of PSI-7977 For Hepatitis C PRINCETON, N.J., June 8, 2011 /PRNewswire/ -- Pharmasset, Inc. (Nasdaq: VRUS) announced today the addition of three treatment cohorts to the ELECTRON trial of PSI-7977, a nucleotide analog polymerase inhibitor, for the treatment of chronic hepatitis C (HCV).
The rapid and consistent antiviral effects and high barrier to resistance demonstrated with PSI-7977 to date provide the rationale for additional exploratory regimens in this setting. This amendment will add one arm exploring 12 weeks of PSI-7977 monotherapy (without peginterferon and ribavirin) and two arms of interferon-sparing therapy: one for 8 weeks of PSI-7977 plus peginterferon and ribavirin (Peg-IFN/RBV) in patients with HCV genotype 2 (GT2) or 3 (GT3) and one for 12 weeks of PSI-7977 plus Peg-IFN/RBV in patients with HCV genotype 1 (GT1) prior null responses.

Locations; New Zealand

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) When Given Together With ABT-333 and Ribavirin (R
Abbott's HCV development programs include its partnership with Enanta Pharmaceuticals to discover protease inhibitors.

An Open-Label Pilot Study to Evaluate the Antiviral Activity, Safety and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-333 and Ribavirin (RBV) in Treatment-Naive Subjects With Genotype 1 Chronic Hepatitis C Virus

Ritonavir-is in a class of antiviral medications called protease inhibitors. Ritonavir as a (boosting agent). Ritonavir boosting is an option to enhance and improve pharmacokinetic profiles of protease inhibitors. It is well established in the treatment of HIV where it leads to more convenient dosing, reduced resistance development and high efficacy.

Pharmaceutical Web Site Abbott
Abbott Pipeline

1 Location
Site Reference ID/Investigator# 48266
Location: San Antonio, Texas 78215

Study of ABT-267 in Treatment Naive Hepatitis C Virus (HCV) Genotype 1 Infected Subjects
ABT-267 HCV NS5A Inhibitor
The purpose of this study is to assess the safety, pharmacokinetics and efficacy of ABT-267 in combination with Peginterferon alpha-2a/Ribavirin (pegIFN/RBV) for 12 weeks in treatment naïve Hepatitis C virus (HCV) genotype 1 infected subjects.

A Blinded, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Pharmacokinetics, and Antiviral Activity of ABT-267 in Combination With Peginterferon Alpha-2a and Ribavirin (pegIFN/RBV) in Treatment-Naïve Subjects With Genotype 1

4 locations

Site Reference ID/Investigator# 48477
Location: Fairfax, Virginia 22031
Site Reference ID/Investigator# 51345
Location: Orlando, Florida 32809
Site Reference ID/Investigator# 48474
Location: San Antonio, Texas 78215
Site Reference ID/Investigator# 51498
Location: Honolulu, Hawaii 96814

Study of SCY-635, Pegasys and Copegus in Hepatitis C
Company Scynexis - SCY-635 is a novel nonimmunosuppressive cyclosporine-based analog that exhibits potent suppression of hepatitis C virus

This study will examine the effectiveness of 28 days of triple combination therapy including SCY-635 with peginterferon alfa 2a and ribavirin in reducing serum HCV RNA levels. An additional 44 weeks of treatment with the currently approved standard of care will be offered to all participants.

A Phase 2a Study of SCY-635 in Combination With Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment-Naive Subjects With Genotype 1 Hepatitis C Infection

Related;Cyclophilin Inhibitor SYC-635 May Reduce Fibrosis in Addition to Inhibiting Hepatitis C Virus Replication

Pharmaceutical Web Site Scynexis

3 Locations

Duke University Medical Center
Location: Durham, North Carolina 27710
Alamo Medical Research
Location: San Antonio, Texas 78215
Quest Clinical Research
Location: San Francisco, California 94115

Efficacy and Safety Study of DEB025/Alisporivir Combined to Standard Therapy (Peg-IFN and Ribavirin) in Chronic Hepatitis C Genotype 1 naïve Patients
Company Novartis, Debio 025 (alisporivir) is the first in a new class of drugs called cyclophilin inhibitors, which could become part of the future standard of care for hepatitis C
This study will assess the safety and efficacy of Alisporivir when added to standard therapy to optimize treatment in patient infected with the Hepatitis C virus who have not been previously treated for this condition

Pharmaceutical Company Web Site Novatis, more info DEB025.

11 locations

Novatis Investigative Site
Location: San Diego, California 92123
Novartis Investigative Site
Location: Ventura, California 93003
Novartis Investigative Site
Location: Bradenton, Florida 34209
Novartis Investigative Site
Location: Baltimore, Maryland 21202
Novartis Investigator Site
Location: St Louis, Missouri 63128
Novartis Investigative Site
Location: Durham, New York 12422
Novartis Investigative Site
Location: New York, New York 10032
Novartis Investigative site
Location: Fayetteville, North Carolina 28304
Novartis Investigative Site
Location: Statesville, North Carolina 28203
Novartis Investigative Site
Location: San Antonio, Texas 78215
Novartis Investigator Site
Location: Fairfax, Virginia 22031

Efficacy and Safety of DEB025 Combined With Peg-IFN Alfa-2a and Ribavirin in Chronic Hepatitis C Genotype 1 Relapsers and Non-responders
The study is to investigate whether HCV GT1 patients with a history of non-response/relapse to SOC benefit from treatment with triple therapy of DEB025 plus SOC compared to triple treatment with placebo matching DEB025 plus SOC.
A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase II Study on Efficacy and Safety of DEB025 Combined With Peg-IFN Alfa-2a and Ribavirin in Chronic Hepatitis C Genotype 1 Relapsers and Non-responders to Previous Peg-IFN Alfa

8 locations found

The Office of Dr. Claudia Martorell
Location: Springfield, Massachusetts 01107
University Hepatitis Center
Location: Bradenton, Florida 34209
Liver Associates of Texas
Location: Houston, Texas 77030
Liver Specialist of Texas
Location: Houston, Texas 77030
Research and Education, Inc.
Location: San Diego, California 92105
Sharp Rees-Stealy Medical Group, Inc.
Location: San Diego, California 92101
Advanced Liver Therapies
Location: Houston, Texas 77030
Alamo Medical Research
Location: San Antonio, Texas 78215

Placebo-Controlled, Dose-Escalation Study of the Safety of IMO-2125 in Hepatitis C-Infected Patients
Company Idera Pharmaceuticals
First-in-humans, phase 1, dose-escalation study with 4 dose levels of single-agent IMO-2125.
A Phase 1, Multi-Center, Placebo-Controlled, Dose-Escalation Study of the Safety of IMO-2125 in Hepatitis C-Infected Patients Unresponsive to Standard Treatment With Pegylated Interferon and Ribavirin

Pharmaceutical Company Idera / IMO-2125

Related- April 2011- Hepatitis C; Idera Delays Initiation of Phase 2 Clinical Trial of IMO-2125

6 Locations
Duke University Medical Center
Location: Durham, North Carolina 27705
Gastoenterstinal Specialist of Georgia, PA
Location: Marietta, Georgia 30060
Henry Ford Med Ctr- Columbus
Location: Novi, Michigan 48377
The Liver Institute
Location: Dallas, Texas 75203
Alamo Medical Research
Location: San Antonio, Texas 78215
University of Colorado Hospital
Location: Aurora, Colorado 80045

Safety, Tolerability and Antiviral Activity of ACH-0141625 or Placebo in Combination With Peginterferon and Ribavirin in HCV Positive Subjects
Company Achillion, ACH-0141625 is a Protease Inhibitor.
Evaluate safety, tolerability and antiviral response of ACH-0141625 compared to Standard of Care in HCV positive subjects.
A Phase IIa, Randomized, Double-blind (Subject and Investigator Blind, Sponsor Open), Placebo-controlled Trial to Evaluate the Safety, Tolerability and Antiviral Activity of Oral ACH-0141625 in Combination With Pegylated Interferon Alpha-2a and Ribavirin

9 locations

AGA Clinical Research Associates
Location: Egg Harbor Township, New Jersey 08234
Bon Secours St. Mary's Hospital of Richmond
Location: Newport News, Virginia 23602
Orlando Immunology Center
Location: Orlando, Florida 32803
Pointe West Infectious Disease
Location: Brandenton, Florida 34209
Kansas City Gastroenterology and Hepatology
Location: Kansas City, Missouri 64131
Vince and Associates Clinical Research
Location: Overland Park, Kansas 66211
North Texas Research Institute
Location: Arlington, Texas 76012
Alamo Medical Research
Location: San Antonio, Texas 78215
Quest Clinical Research
Location: San Francisco, California 94115

MK-5172 Administered With Peginterferon and Ribavirin in Treatment-Naïve Patients With Chronic Hepatitis C (MK-5172-003)
Company Merck, MK-5172 is a HCV NS3/4a Protease Inhibitor.
This study will evaluate the safety, tolerability, and antiviral activity of MK-5172 when administered in combination with peginterferon and ribavirin in treatment-naïve patients with chronic hepatitis C.
A Randomized, Active-Controlled, Dose-Ranging Estimation Study to Evaluate the Safety, Tolerability, and Efficacy of Different Regimens of MK-5172 When Administered Concomitantly With Peginterferon Alfa-2b and Ribavirin in Treatment-Naïve Patients

Pharmaceutical Web Site Merck

25 locations found

Call for Information
Location: Cranston, Rhode Island 02920
Call for Information
Location: Morristown, New Jersey 07960
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Location: Lancaster, Pennsylvania 17604
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Location: Philadelphia, Pennsylvania 19106
Call for Information
Location: Philadelphia, Pennsylvania 19107
Call for Information
Location: Baltimore, Maryland 21229
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Location: Alexandria, Virginia 22306
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Location: Richmond, Virginia 23249
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Location: Norfolk, Virginia 23502
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Location: Statesville, North Carolina 28677
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Location: Hialeah, Florida 33012
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Location: Mobile, Alabama 36693
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Location: Nashville, Tennessee 37211
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Location: Indianapolis, Indiana 46202
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Location: Indianapolis, Indiana 46237
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Location: Saint Louis, Missouri 63104
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Location: Springfield, Missouri 65807
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Location: Arlington, Texas 76012
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Location: Houston, Texas 77005
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Location: Houston, Texas 77030
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Location: San Antonio, Texas 78215
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Location: Austin, Texas 78705
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Location: Long Beach, California 90822
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Location: Newport Beach, California 92663
Call for Information
Location: Bakersfield, California 93301

A Study of Vaniprevir (MK-7009) in Patients With Chronic Hepatitis C Infection After Participation in Other Vaniprevir Studies (MK-7009-028 AM4)
Company name Merck, MK-7009 is a NS3/4a protease inhibitor.
Study Name: A Study of Vaniprevir (MK-7009) in Patients With Chronic Hepatitis C Infection After Participation in Other Vaniprevir Studies (MK-7009-028 AM4)

This study will provide vaniprevir 600 mg or 300 mg twice daily in combination with pegylated interferon and ribavirin to participants with chronic hepatitis C virus (HCV) infection who did not achieve viral eradication while participating in a prior vaniprevir clinical trial.

Pharmaceutical Web Site Merck

2 locations

Call for Information
Location: Charlotte, North Carolina 28203
Call for Information
Location: San Antonio, Texas 78215

Additional Trials

GS 5885 Administered Concomitantly With GS-9451, Tegobuvir and Ribavirin (RBV) in Chronic Genotype 1 Hepatitis C Virus (HCV) Infection
Conditions: Hepatitis C, Chronic2 Locations available

Oral Antivirals (GS-5885, Tegobuvir, and/or GS-9451) With Peginterferon Alfa 2a and Ribavirin in Treatment Experienced Subjects With Chronic Genotype
Conditions: Hepatitis C, Chronic2 Locations available

GS-5885 Alone or in Combination With GS-9451 With Peginterferon Alfa 2a and Ribavirin in Treatment Chronic Genotype 1 Hepatitis C Virus
Conditions: Hepatitis C, Chronic

Safety and Efficacy of the Therapeutic Vaccine GI-5005 Combined With Pegylated Interferon Plus Ribavirin Standard of Care Therapy Versus Standard of C
Conditions: Genotype 1 Chronic Hepatitis C23 Locations available

A Study of Response-Guided Duration of Combination Therapy With GS-9451, Pegasys® and Copegus® With and Without Tegobuvir (GS-9190) in Previously Untr
Conditions: Hepatitis C, Chronic43 Locations available

A Study Evaluating the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of GS-6620 in Treatment Naïve Subjects With Chronic Hepatitis C V
Conditions: Hepatitis C, Chronic11 Locations available

Effective Treatment of Hepatitis C in Substance Users
Conditions: Hepatitis C - Opiate Dependence1 Location available

From;http://www.clinicalconnection.com/clinical_trials/condition/hepatitis_c.aspx

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