March 24, 2015 Trial Update
Bristol-Myers Trial Data
Daclatasvir Plus Sofosbuvir - Genotype 3
If you haven't seen it yet, study results from the phase III study (ALLY-3;ClinicalTrials.gov: NCT02032901) has been published in the April issue of Hepatology, here is the link;
All-oral 12-week treatment with daclatasvir plus sofosbuvir in patients with hepatitis C virus genotype 3 infection: ALLY-3 phase III study.
In short, trial results using daclatasvir with sofosbuvir in HCV genotype 3 without cirrhosis and without ribavirin - SVR12 was achieved in 96% of patients. In people with cirrhosis, both treatment-experienced or treatment-naive - SVR12 was lower, at 63%.
In genotype 3, 100% of patients without cirrhosis, and without using ribavirin achieved SVR12.
HCV genotypes 2, 3, 4, 5, or 6
Treatment experienced, treatment-naive, with and without cirrhosis
Purpose
This study will evaluate the safety, tolerability, and efficacy of GS-9857 plus sofosbuvir (SOF)/GS-5816 fixed dose combination (FDC) in adults with chronic non genotype 1 hepatitis C virus (HCV) infection.
Contact: Gilead Study Team 367-11681169alerts@gilead.com
Purpose
This study will evaluate the safety, tolerability, and efficacy of GS-9857 plus sofosbuvir (SOF)/GS-5816 fixed dose combination (FDC) in adults with chronic genotype 1 hepatitis C virus (HCV)
Contacts
Contact: Gilead Study Team 367-11681169alerts@gilead.com
Locations
United States, California
Cedars Sinai Medical Center Recruiting
Los Angeles, California, United States
Stanford University Recruiting
Palo Alto, California, United States
Huntington Memorial Hospital Liver Center Recruiting
Pasadena, California, United States
Medical Associates Research Group, Inc. Recruiting
San Diego, California, United States
United States, Florida
Borland-Groover Clinic Recruiting
Jacksonville, Florida, United States
University of Miami Recruiting
Miami, Florida, United States
Orlando Immunology center Recruiting
Orlando, Florida, United States
South Florida Center of Gastroenterology, P.A. Recruiting
Wellington, Florida, United States
United States, Georgia
Center for Hep C/Atlanta Medical Center Recruiting
Atlanta, Georgia, United States
Gastrointestinal Specialists of Georgia, PC Recruiting
Marietta, Georgia, United States
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States
United States, Indiana
Indianapolis Gastroenterology & Hepatology, Inc. Recruiting
Indianapolis, Indiana, United States
United States, Massachusetts
Beth Isreal Deconess Medical Center Recruiting
Boston, Massachusetts, United States
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States
United States, Michigan
Henry Ford Hospital and Health System Recruiting
Detroit, Michigan, United States
United States, New Jersey
ID Care Recruiting
Hillsborough, New Jersey, United States
United States, New Mexico
Southwest Care Center Recruiting
Santa Fe, New Mexico, United States
United States, New York
North Shore/Long Island Jewish PRIME Recruiting
Lake Success, New York, United States
United States, North Carolina
Cumberland Research Associates, LLC Recruiting
Fayetteville, North Carolina, United States
Digestive Health Specialists, PA Recruiting
Winston-Salem, North Carolina, United States
United States, Pennsylvania
University of Pennsylvania Health Systems Recruiting
Philadelphia, Pennsylvania, United States
UPMC Center for Liver Diseases Recruiting
Pittsburgh, Pennsylvania, United States
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States
United States, Tennessee
Gastro One Recruiting
Germantown, Tennessee, United States
Nashville Gastrointestinal Specialists, Inc. Recruiting
Nashville, Tennessee, United States
United States, Texas
Texas Liver Institute Recruiting
San Antonio, Texas, United States
United States, Virginia
Liver Institute of Virginia Recruiting
Richmond, Virginia, United States
New Zealand
Auckland Clinical Studies Recruiting
Auckland, New Zealand
Christchurch Clinical Studies Trust Recruiting
Christchurch, New Zealand
Puerto Rico
Fundacion de Investigacion de Diego Recruiting
San Juan, Puerto Rico
Sponsors and Collaborators
Gilead Sciences
In short, trial results using daclatasvir with sofosbuvir in HCV genotype 3 without cirrhosis and without ribavirin - SVR12 was achieved in 96% of patients. In people with cirrhosis, both treatment-experienced or treatment-naive - SVR12 was lower, at 63%.
In summary, a 12-week regimen of DCV plus SOF achieved SVR12 in 96% of treatment-naïve and treatment-experienced patients with genotype 3 infection without cirrhosis and was well tolerated. This regimen, without the addition of RBV and with a shorter treatment duration relative to currently approved all-oral regimens, demonstrated high SVR12 rates across patient subgroups, except in patients with cirrhosis and regardless of past treatment response. These findings support the 12-week regimen of DCV plus SOF as an efficacious, well-tolerated treatment option. Additional evaluation to optimize efficacy in genotype 3–infected patients with cirrhosis is underway.
In The News
This month Bristol-Myers announced that the Food and Drug Administration (FDA) has accepted for review the resubmitted New Drug Application (NDA) of daclatasvir in combination with sofosbuvir for the treatment of chronic hepatitis C (HCV) genotype 3. Bristol-Myers withdrew its FDA application for daclatasvir and asunaprevir to treat genotype 1b last October.
Bristol-Myers trial information is provided below, as well as Gilead's trial for HCV genotypes 2, 3, 4, 5, or 6, using GS-9857 Plus Sofosbuvir/GS-5816 Fixed Dose Combination, and one study for genotype 1 patients.
Gilead Sciences is currently evaluating a single-tablet of sofosbuvir and GS-5816 in four Phase III studies, unfortunately those trials are no longer recruiting. Gilead hopes that the above mentioned clinical trial using GS-9857 a pan-genotypic protease inhibitor in combination with sofosbuvir and GS-5816 may potentially further reduce treatment duration from eight to 12 weeks to four to six weeks, read more here.
Genotype 3 & 1 Gilead
2014 Gilead Trial Data; Sofosbuvir Plus GS-5816
Gilead Announces Phase 2 Data for Investigational All-Oral Regimen of Sofosbuvir Plus GS-5816 for the Treatment of Chronic Hepatitis C
Gilead Announces Phase 2 Data for Investigational All-Oral Regimen of Sofosbuvir Plus GS-5816 for the Treatment of Chronic Hepatitis C
With and without cirrhosis, Genotype 1 and 3
*and with and without using ribavirin
| GT1 with cirrhosis | GT3 without cirrhosis | GT3 with cirrhosis | |||||||||||
| SOF+GS-5816 100 mg | 100% (n=20/20) | 100% (n=7/7) | 100% (n=27/27) | 88% (n=23/26) | |||||||||
| SOF+GS-5816 100 mg +RBV | 100% (n=18/18) | 90% (n=9/10) | 100% (n=26/26) |
96% (n=25/26)
| |||||||||
In genotype 3, 100% of patients without cirrhosis, and without using ribavirin achieved SVR12.
In genotype 3 patients with cirrhosis SVR12 is at 88%.
However, 96% of genotype 3 treatment-experienced patients with cirrhosis achieved SVR12 using ribavirin.
In February Gilead told investors Phase III results are expected in the third quarter of 2015. You can read the full transcript @ Seeking Alpha, registration is required.
Gilead Sciences
This study is currently recruiting participants
ClinicalTrials.gov Identifier:
NCT02378961
HCV genotypes 2, 3, 4, 5, or 6
Treatment experienced, treatment-naive, with and without cirrhosis
Purpose
This study will evaluate the safety, tolerability, and efficacy of GS-9857 plus sofosbuvir (SOF)/GS-5816 fixed dose combination (FDC) in adults with chronic non genotype 1 hepatitis C virus (HCV) infection.
Contact: Gilead Study Team 367-11681169alerts@gilead.com
Locations
United States, California
Cedars Sinai Medical Center Recruiting
Los Angeles, California, United States
Stanford University Recruiting
Palo Alto, California, United States
Huntington Memorial Hospital Liver Center Recruiting
Pasadena, California, United States
Medical Associates Research Group, Inc. Recruiting
San Diego, California, United States
United States, Florida
Borland-Groover Clinic Recruiting
Jacksonville, Florida, United States
University of Miami Recruiting
Miami, Florida, United States
Orlando Immunology center Recruiting
Orlando, Florida, United States
South Florida Center of Gastroenterology, P.A. Recruiting
Wellington, Florida, United States
United States, Georgia
Center for Hep C/Atlanta Medical Center Recruiting
Atlanta, Georgia, United States
Gastrointestinal Specialists of Georgia, PC Recruiting
Marietta, Georgia, United States
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States
United States, Indiana
Indianapolis Gastroenterology & Hepatology, Inc. Recruiting
Indianapolis, Indiana, United States
United States, Massachusetts
Beth Isreal Deconess Medical Center Recruiting
Boston, Massachusetts, United States
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States
United States, Michigan
Henry Ford Hospital and Health System Recruiting
Detroit, Michigan, United States
United States, New Jersey
ID Care Recruiting
Hillsborough, New Jersey, United States
United States, New Mexico
Southwest Care Center Recruiting
Santa Fe, New Mexico, United States
United States, New York
North Shore/Long Island Jewish PRIME Recruiting
Lake Success, New York, United States
United States, North Carolina
Cumberland Research Associates, LLC Recruiting
Fayetteville, North Carolina, United States
Digestive Health Specialists, PA Recruiting
Winston-Salem, North Carolina, United States
United States, Pennsylvania
University of Pennsylvania Health Systems Recruiting
Philadelphia, Pennsylvania, United States
UPMC Center for Liver Diseases Recruiting
Pittsburgh, Pennsylvania, United States
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States
United States, Tennessee
Gastro One Recruiting
Germantown, Tennessee, United States
Nashville Gastrointestinal Specialists, Inc. Recruiting
Nashville, Tennessee, United States
United States, Texas
Texas Liver Institute Recruiting
San Antonio, Texas, United States
United States, Virginia
Liver Institute of Virginia Recruiting
Richmond, Virginia, United States
New Zealand
Auckland Clinical Studies Recruiting
Auckland, New Zealand
Christchurch Clinical Studies Trust Recruiting
Christchurch, New Zealand
Puerto Rico
Fundacion de Investigacion de Diego Recruiting
San Juan, Puerto Rico
Sponsors and Collaborators
Gilead Sciences
Genotype 1
This study is currently recruiting participants
Cedars Sinai Medical Center Recruiting
Los Angeles, California, United States
Stanford University Recruiting
Palo Alto, California, United States
Huntington Memorial Hospital Liver Center Recruiting
Pasadena, California, United States
Medical Associates Research Group, Inc. Recruiting
San Diego, California, United States
United States, Florida
Borland-Groover Clinic Recruiting
Jacksonville, Florida, United States
University of Miami Recruiting
Miami, Florida, United States
Orlando Immunology center Recruiting
Orlando, Florida, United States
South Florida Center of Gastroenterology, P.A. Recruiting
Wellington, Florida, United States
United States, Georgia
Center for Hep C/Atlanta Medical Center Recruiting
Atlanta, Georgia, United States
Gastrointestinal Specialists of Georgia, PC Recruiting
Marietta, Georgia, United States
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States
United States, Indiana
Indianapolis Gastroenterology & Hepatology, Inc. Recruiting
Indianapolis, Indiana, United States
United States, Massachusetts
Beth Isreal Deconess Medical Center Recruiting
Boston, Massachusetts, United States
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States
United States, Michigan
Henry Ford Hospital and Health System Recruiting
Detroit, Michigan, United States
United States, New Jersey
ID Care Recruiting
Hillsborough, New Jersey, United States
United States, New Mexico
Southwest Care Center Recruiting
Santa Fe, New Mexico, United States
United States, New York
North Shore/Long Island Jewish PRIME Recruiting
Lake Success, New York, United States
United States, North Carolina
Cumberland Research Associates, LLC Recruiting
Fayetteville, North Carolina, United States
Digestive Health Specialists, PA Recruiting
Winston-Salem, North Carolina, United States
United States, Pennsylvania
University of Pennsylvania Health Systems Recruiting
Philadelphia, Pennsylvania, United States
UPMC Center for Liver Diseases Recruiting
Pittsburgh, Pennsylvania, United States
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States
United States, Tennessee
Gastro One Recruiting
Germantown, Tennessee, United States
Nashville Gastrointestinal Specialists, Inc. Recruiting
Nashville, Tennessee, United States
United States, Texas
Texas Liver Institute Recruiting
San Antonio, Texas, United States
United States, Virginia
Liver Institute of Virginia Recruiting
Richmond, Virginia, United States
New Zealand
Auckland Clinical Studies Recruiting
Auckland, New Zealand
Christchurch Clinical Studies Trust Recruiting
Christchurch, New Zealand
Puerto Rico
Fundacion de Investigacion de Diego Recruiting
San Juan, Puerto Rico
Sponsors and Collaborators
Gilead Sciences
Genotype 1
This study is currently recruiting participants
Phase 2
ClinicalTrials.gov Identifier:
NCT02378935
Purpose
This study will evaluate the safety, tolerability, and efficacy of GS-9857 plus sofosbuvir (SOF)/GS-5816 fixed dose combination (FDC) in adults with chronic genotype 1 hepatitis C virus (HCV)
infection.
Contact: Gilead Study Team 367-11681169alerts@gilead.com
Locations
United States, California
Cedars Sinai Medical Center Recruiting
Los Angeles, California, United States
Stanford University Recruiting
Palo Alto, California, United States
Huntington Memorial Hospital Liver Center Recruiting
Pasadena, California, United States
Medical Associates Research Group, Inc. Recruiting
San Diego, California, United States
United States, Florida
Borland-Groover Clinic Recruiting
Jacksonville, Florida, United States
University of Miami Recruiting
Miami, Florida, United States
Orlando Immunology center Recruiting
Orlando, Florida, United States
South Florida Center of Gastroenterology, P.A. Recruiting
Wellington, Florida, United States
United States, Georgia
Center for Hep C/Atlanta Medical Center Recruiting
Atlanta, Georgia, United States
Gastrointestinal Specialists of Georgia, PC Recruiting
Marietta, Georgia, United States
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States
United States, Indiana
Indianapolis Gastroenterology & Hepatology, Inc. Recruiting
Indianapolis, Indiana, United States
United States, Massachusetts
Beth Isreal Deconess Medical Center Recruiting
Boston, Massachusetts, United States
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States
United States, Michigan
Henry Ford Hospital and Health System Recruiting
Detroit, Michigan, United States
United States, New Jersey
ID Care Recruiting
Hillsborough, New Jersey, United States
United States, New Mexico
Southwest Care Center Recruiting
Santa Fe, New Mexico, United States
United States, New York
North Shore/Long Island Jewish PRIME Recruiting
Lake Success, New York, United States
United States, North Carolina
Cumberland Research Associates, LLC Recruiting
Fayetteville, North Carolina, United States
Digestive Health Specialists, PA Recruiting
Winston-Salem, North Carolina, United States
United States, Pennsylvania
University of Pennsylvania Health Systems Recruiting
Philadelphia, Pennsylvania, United States
UPMC Center for Liver Diseases Recruiting
Pittsburgh, Pennsylvania, United States
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States
United States, Tennessee
Gastro One Recruiting
Germantown, Tennessee, United States
Nashville Gastrointestinal Specialists, Inc. Recruiting
Nashville, Tennessee, United States
United States, Texas
Texas Liver Institute Recruiting
San Antonio, Texas, United States
United States, Virginia
Liver Institute of Virginia Recruiting
Richmond, Virginia, United States
New Zealand
Auckland Clinical Studies Recruiting
Auckland, New Zealand
Christchurch Clinical Studies Trust Recruiting
Christchurch, New Zealand
Puerto Rico
Fundacion de Investigacion de Diego Recruiting
San Juan, Puerto Rico
Gilead Sciences
Additional Gilead trials, here.
The HCV clinical trials in this post are not a complete list; to learn more about Hepatitis C virus clinical trials or to find out if a study is enrolling patients in your area, please click here.
Bristol-Myers
Last verified: February 2015
Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.
NCT02304159
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02304159
Purpose
This is a randomized, open label, single center safety and efficacy study. At least 40 cirrhotic subjects with HCV genotype 3 will receive standard of care treatment of sofosbuvir and ribavirin (SOF/RBV) as well as 60 mg daily of Daclatasvir (investigational product). Subjects will be randomized in a 1:1 to receive either:
Group A: 16 weeks of DCV/SOF/RBV
Group B: 24 weeks of DCV/SOF/RBV
Subjects will return to the study center at various time points throughout the 16 or 24 weeks of treatment in addition to 12 weeks post taking last dose of study drug to monitor safety and efficacy. These visits will be according to standard of care.
Contacts
Contact: Tarek Hassanein, M.D. 619-522-0330 thassanein@livercenters.com
Contact: Fatma Barakat, MAS 858-717-0241 fbarakat@livercenters.com
Locations
United States, California
Southern California Research Center Recruiting
Coronado, California, United States, 92118
Contact: Karel Biando 619-522-0330
Principal Investigator: Tarek Hassanein, MD
WHAT IS EXPANDED ACCESS?
Bristol-Myers
Daclatasvir Plus Sofosbuvir - Clinical Trials
Completed
Phase III Daclatasvir, Sofosbuvir, and Ribavirin in Cirrhotic Subjects and Subjects Post-liver Transplant
Recruiting
Safety and Efficacy Study of Daclatasvir 60mg, Sofosbuvir 400mg, and Ribavirin (Dosed Based Upon Weight) in Subjects With Chronic Genotype 3 Hepatitis C Infection With or Without Prior Treatment Experience and Compensated Advanced Cirrhosis for 12 or 16 Weeks
Recruiting
Safety and Efficacy Study of Daclatasvir 60mg, Sofosbuvir 400mg, and Ribavirin (Dosed Based Upon Weight) in Subjects With Chronic Genotype 3 Hepatitis C Infection With or Without Prior Treatment Experience and Compensated Advanced Cirrhosis for 12 or 16 Weeks
ClinicalTrials.gov Identifier:
NCT02319031
Last updated: March 24, 2015NCT02319031
Last verified: February 2015
Purpose
The purpose of this study is to determine if the use of Daclatasvir, Sofosbuvir, and Ribavirin in combination is safe and effective in the treatment of Genotype 3 Chronic Hepatitis C (HCV) in patients with compensated cirrhosis. Patients in this study may have already been treated prior for HCV or may have never received treatment for their HCV.
The purpose of this study is to determine if the use of Daclatasvir, Sofosbuvir, and Ribavirin in combination is safe and effective in the treatment of Genotype 3 Chronic Hepatitis C (HCV) in patients with compensated cirrhosis. Patients in this study may have already been treated prior for HCV or may have never received treatment for their HCV.
Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.
Locations
Australia, New South Wales
Local Institution Recruiting
Darlinghurst, New South Wales, Australia, 2010
Contact: Site 0002
Australia, New South Wales
Local Institution Recruiting
Darlinghurst, New South Wales, Australia, 2010
Contact: Site 0002
Australia, Queensland
Local Institution Recruiting
Greenslopes, Queensland, Australia, 4120
Contact: Site 0006
Local Institution Recruiting
Greenslopes, Queensland, Australia, 4120
Contact: Site 0006
Australia, South Australia
Local Institution Recruiting
Adelaide, South Australia, Australia, 5000
Contact: Site 0005
Local Institution Recruiting
Adelaide, South Australia, Australia, 5000
Contact: Site 0005
Australia, Victoria
Local Institution Recruiting
Clayton, Victoria, Australia, 3168
Contact: Site 0001
Local Institution Recruiting
Clayton, Victoria, Australia, 3168
Contact: Site 0001
Local Institution Recruiting
Fitzroy, Victoria, Australia, 3065
Contact: Site 0003
Fitzroy, Victoria, Australia, 3065
Contact: Site 0003
Local Institution Recruiting
Heidelberg, Victoria, Australia, 3084
Contact: Site 0004
Heidelberg, Victoria, Australia, 3084
Contact: Site 0004
France
Local Institution Recruiting
Creteil Cedex, France, 94010
Contact: Site 0007
Local Institution Recruiting
Creteil Cedex, France, 94010
Contact: Site 0007
Local Institution Recruiting
Grenoble Cedex 09, France, 38043
Contact: Site 0010
Grenoble Cedex 09, France, 38043
Contact: Site 0010
Local Institution Recruiting
Paris Cedex 14, France, 75679
Contact: Site 0009
Paris Cedex 14, France, 75679
Contact: Site 0009
Local Institution Recruiting
Vandoeuvre Les Nancy, France, 54511
Contact: Site 0008
Sponsors and Collaborators
Bristol-Myers Squibb
Vandoeuvre Les Nancy, France, 54511
Contact: Site 0008
Sponsors and Collaborators
Bristol-Myers Squibb
Recruiting
ClinicalTrials.gov Identifier:NCT02304159
Verified January 2015 by Southern California Research Center
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02304159
This is a randomized, open label, single center safety and efficacy study. At least 40 cirrhotic subjects with HCV genotype 3 will receive standard of care treatment of sofosbuvir and ribavirin (SOF/RBV) as well as 60 mg daily of Daclatasvir (investigational product). Subjects will be randomized in a 1:1 to receive either:
Group A: 16 weeks of DCV/SOF/RBV
Group B: 24 weeks of DCV/SOF/RBV
Subjects will return to the study center at various time points throughout the 16 or 24 weeks of treatment in addition to 12 weeks post taking last dose of study drug to monitor safety and efficacy. These visits will be according to standard of care.
Contacts
Contact: Tarek Hassanein, M.D. 619-522-0330 thassanein@livercenters.com
Contact: Fatma Barakat, MAS 858-717-0241 fbarakat@livercenters.com
Locations
United States, California
Southern California Research Center Recruiting
Coronado, California, United States, 92118
Contact: Karel Biando 619-522-0330
Principal Investigator: Tarek Hassanein, MD
WHAT IS EXPANDED ACCESS?
A process regulated by the Food and Drug Administration (FDA) that allows manufacturers to provide investigational new drugs to patients with serious diseases or conditions who cannot participate in a clinical trial.
For more information on expanded access programs, visit the FDA Understanding Expanded Access/Compassionate Use Web site.
Expanded access is currently available for this treatment.
Purpose
The primary objective of this program is to provide DCV for 24 weeks to be given in combination with SOF to subjects with chronic hepatitis C with decompensated cirrhosis or post-liver transplant subjects with chronic hepatitis C recurrence with either advanced fibrosis or fibrosing cholestatic hepatitis and who have a serious or immediately life-threatening condition or experienced an event that has decreased their life expectancy to <12 months, therefore, no research hypothesis will be tested and no specific endpoints are defined. However, safety data will be collected throughout the study as well as efficacy data
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02161939
Contacts
Contact: HCV-TARGET/University of Florida -- Angie Bauer bauera@medicine.ufl.edu
Contact: Lauren Morelli lauren.morelli@medicine.ufl.edu
Locations
United States, Arizona
Mayo Clinic
Phoenix, Arizona, United States, 85054
Contact: Hugo Vargas, Site 0002 480-342-1010
For more information on expanded access programs, visit the FDA Understanding Expanded Access/Compassionate Use Web site.
Available
Expanded access is currently available for this treatment
ClinicalTrials.gov Identifier:
NCT02097966
NCT02097966
Purpose
The primary objective of this program is to provide Daclatasvir in combination with Sofosbuvir with or without Ribavirin to subjects with chronic Hepatitis C who are at a high risk of liver decompensation or death within 12 months if left untreated and who have no available therapeutic options.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02097966
The primary objective of this program is to provide Daclatasvir in combination with Sofosbuvir with or without Ribavirin to subjects with chronic Hepatitis C who are at a high risk of liver decompensation or death within 12 months if left untreated and who have no available therapeutic options.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02097966
This program is conducted in the EU (Germany, Austria, Norway, The Netherlands, Sweden and United Kingdom only)
Contacts
Contact: For Site information please email: Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial site that are recruiting have contact information at this time
Study Locations
Austria
Local Institution
Amstetten, Austria
Contact: Site 0090
Contacts
Contact: For Site information please email: Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial site that are recruiting have contact information at this time
Study Locations
Austria
Local Institution
Amstetten, Austria
Contact: Site 0090
Local Institution
Braunua/Inn, Austria
Contact: Site 0074
Braunua/Inn, Austria
Contact: Site 0074
Local Institution
Graz, Austria
Contact: Site 0022
Graz, Austria
Contact: Site 0022
Local Institution
Innsbruck, Austria
Contact: Site 0098
Innsbruck, Austria
Contact: Site 0098
Local Institution
Innsbruck, Austria
Contact: Site 0059
Innsbruck, Austria
Contact: Site 0059
Local Institution
Linz, Austria
Contact: Site 0026
Linz, Austria
Contact: Site 0026
Local Institution
Linz, Austria
Contact: Site 0024
Linz, Austria
Contact: Site 0024
Local Institution
Oberndorf, Austria
Contact: Site 0048
Oberndorf, Austria
Contact: Site 0048
Local Institution
Oberndorf, Austria
Contact: Site 0047
Oberndorf, Austria
Contact: Site 0047
Local Institution
Oberpullendorf, Austria
Contact: Site 0094
Oberpullendorf, Austria
Contact: Site 0094
Local Institution
Salzburg, Austria
Contact: Site 0060
Salzburg, Austria
Contact: Site 0060
Local Institution
Vienna, Austria
Contact: Site 0075
Vienna, Austria
Contact: Site 0075
Local Institution
Wien, Austria
Contact: Site 0054
Wien, Austria
Contact: Site 0054
Local Institution
Wien, Austria
Contact: Site 0044
Wien, Austria
Contact: Site 0044
Local Institution
Wien, Austria
Contact: Site 0097
Wien, Austria
Contact: Site 0097
Local Institution
Wien, Austria
Contact: Site 0023
Wien, Austria
Contact: Site 0023
Germany
Local Institution
Aachen, Germany
Contact: Site 0064
Local Institution
Aachen, Germany
Contact: Site 0064
Local Institution
Augsburg, Germany
Contact: Site 0002
Augsburg, Germany
Contact: Site 0002
Local Institution
Berlin, Germany
Contact: Site 0001
Berlin, Germany
Contact: Site 0001
Local Institution
Berlin, Germany
Contact: Site 0005
Berlin, Germany
Contact: Site 0005
Local Institution
Berlin, Germany
Contact: Site 0041
Local Institution
Berlin, Germany
Contact: Site 0040
Berlin, Germany
Contact: Site 0041
Local Institution
Berlin, Germany
Contact: Site 0040
Local Institution
Berlin, Germany
Contact: Site 0037
Berlin, Germany
Contact: Site 0037
Local Institution
Berlin, Germany
Contact: Site 0038
Local Institution
Berlin, Germany
Contact: Site 0107
Berlin, Germany
Contact: Site 0038
Local Institution
Berlin, Germany
Contact: Site 0107
Local Institution
Bonn, Germany
Contact: Site 0046
Bonn, Germany
Contact: Site 0046
Local Institution
Bonn, Germany
Contact: Site 0015
Bonn, Germany
Contact: Site 0015
Local Institution
Cologne, Germany
Contact: Site 0050
Cologne, Germany
Contact: Site 0050
Local Institution
Essen, Germany
Contact: Site 0035
Essen, Germany
Contact: Site 0035
Local Institution
Essen, Germany
Contact: Site 0006
Essen, Germany
Contact: Site 0006
Local Institution
Frankfurt, Germany
Contact: Site 0108
Frankfurt, Germany
Contact: Site 0108
Local Institution
Frankfurt, Germany
Contact: Site 0007
Frankfurt, Germany
Contact: Site 0007
Local Institution
Frankfurt Am Main, Germany
Contact: Site 0061
Frankfurt Am Main, Germany
Contact: Site 0061
Local Institution
Hamburg, Germany
Contact: Site 0036
Hamburg, Germany
Contact: Site 0036
Local Institution
Hamburg, Germany
Contact: Site 0021
Hamburg, Germany
Contact: Site 0021
Local Institution
Hamburg, Germany
Contact: Site 0031
Hamburg, Germany
Contact: Site 0031
Local Institution
Hamburg, Germany
Contact: Site 0014
Hamburg, Germany
Contact: Site 0014
Local Institution
Hannover, Germany
Contact: Site 0068
Hannover, Germany
Contact: Site 0068
Local Institution
Hannover, Germany
Contact: Site 0019
Hannover, Germany
Contact: Site 0019
Local Institution
Heidelberg, Germany
Contact: Site 0011
Heidelberg, Germany
Contact: Site 0011
Local Institution
Herne, Germany
Contact: Site 0028
Herne, Germany
Contact: Site 0028
Local Institution
Jena, Germany
Contact: Site 0042
Jena, Germany
Contact: Site 0042
Local Institution
Kiel, Germany
Contact: Site 0030
Kiel, Germany
Contact: Site 0030
Local Institution
Leipzig, Germany
Contact: Site 0009
Leipzig, Germany
Contact: Site 0009
Local Institution
Muenchen, Germany
Contact: Site 0034
Muenchen, Germany
Contact: Site 0034
Local Institution
Muenster, Germany
Contact: Site 0008
Local Institution
Munchen, Germany
Contact: Site 0033
Muenster, Germany
Contact: Site 0008
Local Institution
Munchen, Germany
Contact: Site 0033
Local Institution
Munchen, Germany
Contact: Site 0039
Munchen, Germany
Contact: Site 0039
Local Institution
Stuttgart, Germany
Contact: Site 0032
Stuttgart, Germany
Contact: Site 0032
Local Institution
Tuebingen, Germany
Contact: Site 0004
Tuebingen, Germany
Contact: Site 0004
Local Institution
Ulm, Germany
Contact: Site 0003
Ulm, Germany
Contact: Site 0003
Local Institution
Wuerzburg, Germany
Contact: Site 0029
Wuerzburg, Germany
Contact: Site 0029
Local Institution
Wuerzburg, Germany
Contact: Site 0027
Netherlands
Wuerzburg, Germany
Contact: Site 0027
Netherlands
Local Institution
Amsterdam, Netherlands
Contact: Site 0066
Amsterdam, Netherlands
Contact: Site 0066
Local Institution
Amsterdam, Netherlands
Contact: Site 0017
Amsterdam, Netherlands
Contact: Site 0017
Local Institution
Rotterdam, Netherlands
Contact: Site 0016
Rotterdam, Netherlands
Contact: Site 0016
Local Institution
Urecht, Netherlands
Contact: Site 0018
Urecht, Netherlands
Contact: Site 0018
Sweden
Local Institution
Falun, Sweden
Contact: Site 0073
Local Institution
Falun, Sweden
Contact: Site 0073
Local Institution
Gothenburg, Sweden
Contact: Site 0058
Gothenburg, Sweden
Contact: Site 0058
Local Institution
Helsingborg, Sweden
Contact: Site 0051
Helsingborg, Sweden
Contact: Site 0051
Local Institution
Kalmar, Sweden, SE-391 85
Contact: Site 0053
Kalmar, Sweden, SE-391 85
Contact: Site 0053
Local Institution
Lulea, Sweden
Contact: Site 0106
Lulea, Sweden
Contact: Site 0106
Local Institution
Lund, Sweden
Contact: Site 0065
Lund, Sweden
Contact: Site 0065
Local Institution
Stockholm, Sweden
Contact: Site 0063
Stockholm, Sweden
Contact: Site 0063
Local Institution
Sundsvall, Sweden
Contact: Site 0052
Sundsvall, Sweden
Contact: Site 0052
United Kingdom
Local Institution
Plymouth, Devon, United Kingdom
Contact: Site 0085
Local Institution
Plymouth, Devon, United Kingdom
Contact: Site 0085
Local Institution
London, Greater London, United Kingdom
Contact: Site 0078
London, Greater London, United Kingdom
Contact: Site 0078
Local Institution
London, Greater London, United Kingdom
Contact: Site 0081
London, Greater London, United Kingdom
Contact: Site 0081
Local Institution
Manchester, Greater Manchester, United Kingdom
Contact: Site 0087
Manchester, Greater Manchester, United Kingdom
Contact: Site 0087
Local Institution
Manchester, Greater Manchester, United Kingdom
Contact: Site 0076
Manchester, Greater Manchester, United Kingdom
Contact: Site 0076
Local Instituition
Liverpool, Merseyside, United Kingdom, L7 8XP
Contact: Site 0080
Liverpool, Merseyside, United Kingdom, L7 8XP
Contact: Site 0080
Local Institution
Nottingham, Nottinghamshire, United Kingdom
Contact: Site 0077
Nottingham, Nottinghamshire, United Kingdom
Contact: Site 0077
Local Institution
Oxford, Oxfordshire, United Kingdom
Contact: Site 0089
Oxford, Oxfordshire, United Kingdom
Contact: Site 0089
Local Institution
Newcastle Upon Tyne, Tyne And Wear, United Kingdom
Contact: Site 0084
Newcastle Upon Tyne, Tyne And Wear, United Kingdom
Contact: Site 0084
Local Institution
Birmingham, West Midlands, United Kingdom
Contact: Site 0086
Birmingham, West Midlands, United Kingdom
Contact: Site 0086
Local Institution
Leeds, Yorkshire, United Kingdom
Contact: Site 0079
Leeds, Yorkshire, United Kingdom
Contact: Site 0079
Local Institution
Brighton, United Kingdom
Contact: Site 0082
Brighton, United Kingdom
Contact: Site 0082
Local Institution
Cardiff, United Kingdom
Contact: Site 0104
Cardiff, United Kingdom
Contact: Site 0104
Local Institution
Frimley, United Kingdom
Contact: Site 0088
Frimley, United Kingdom
Contact: Site 0088
Local Institution
Guildford, United Kingdom
Contact: Site 0092
Guildford, United Kingdom
Contact: Site 0092
Local Institution
London, United Kingdom
Contact: Site 0069
London, United Kingdom
Contact: Site 0069
Local Institution
London, United Kingdom
Contact: Site 0083
London, United Kingdom
Contact: Site 0083
Local Institution
London, United Kingdom
Contact: Site 0055
London, United Kingdom
Contact: Site 0055
Local Institution
London, United Kingdom
Contact: Site 0057
London, United Kingdom
Contact: Site 0057
Local Institution
Wrexham, United Kingdom
Contact: Site 0105
Sponsors and Collaborators
Bristol-Myers Squibb
Available
Wrexham, United Kingdom
Contact: Site 0105
Sponsors and Collaborators
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02161939
NCT02161939
Purpose
The primary objective of this program is to provide DCV for 24 weeks to be given in combination with SOF to subjects with chronic hepatitis C with decompensated cirrhosis or post-liver transplant subjects with chronic hepatitis C recurrence with either advanced fibrosis or fibrosing cholestatic hepatitis and who have a serious or immediately life-threatening condition or experienced an event that has decreased their life expectancy to <12 months, therefore, no research hypothesis will be tested and no specific endpoints are defined. However, safety data will be collected throughout the study as well as efficacy data
Please refer to this study by its ClinicalTrials.gov identifier: NCT02161939
Contacts
Contact: HCV-TARGET/University of Florida -- Angie Bauer bauera@medicine.ufl.edu
Contact: Lauren Morelli lauren.morelli@medicine.ufl.edu
Locations
United States, Arizona
Mayo Clinic
Phoenix, Arizona, United States, 85054
Contact: Hugo Vargas, Site 0002 480-342-1010
United States, California
USC - Keck Medical Center
Los Angeles, California, United States, 90033
Contact: Saro Khemichian, Site 0019 323-442-6171
USC - Keck Medical Center
Los Angeles, California, United States, 90033
Contact: Saro Khemichian, Site 0019 323-442-6171
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Contact: Conseuelo Soldevila-Pico, Site 0004 352-273-9465
University of Florida
Gainesville, Florida, United States, 32610
Contact: Conseuelo Soldevila-Pico, Site 0004 352-273-9465
United States, Georgia
Piedmont Transplant
Atlanta, Georgia, United States, 30309
Contact: Devina Bhasin, Site 0021 404-548-0937
Piedmont Transplant
Atlanta, Georgia, United States, 30309
Contact: Devina Bhasin, Site 0021 404-548-0937
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
Contact: Paul Kwo, Site 0010 317-274-3090
Indiana University
Indianapolis, Indiana, United States, 46202
Contact: Paul Kwo, Site 0010 317-274-3090
United States, Louisiana
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
Contact: Shobha Joshi, Site 0013 504-842-4015
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
Contact: Shobha Joshi, Site 0013 504-842-4015
United States, Massachusetts
Mass General
Boston, Massachusetts, United States, 02114
Contact: Ray Chung, Site 0008 617-643-0446
Mass General
Boston, Massachusetts, United States, 02114
Contact: Ray Chung, Site 0008 617-643-0446
United States, Michigan
Henry Ford
Detroit, Michigan, United States, 48202
Contact: Stuart Gordon, Site 0011 313-916-9465
Henry Ford
Detroit, Michigan, United States, 48202
Contact: Stuart Gordon, Site 0011 313-916-9465
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Contact: Paul Gaglio, Site 0017 718-920-4644
Montefiore Medical Center
Bronx, New York, United States, 10467
Contact: Paul Gaglio, Site 0017 718-920-4644
Columbia University Medical Center
New York, New York, United States, 10032
Contact: Robert Brown, Site 0007 212-305-0662
New York, New York, United States, 10032
Contact: Robert Brown, Site 0007 212-305-0662
United States, North Carolina
UNC
Chapel Hill, North Carolina, United States, 27599
Contact: Jama Darling, Site 0014 919-933-8938
UNC
Chapel Hill, North Carolina, United States, 27599
Contact: Jama Darling, Site 0014 919-933-8938
Carolinas Healthcare Institute
Charlotte, North Carolina, United States, 28204
Contact: Philipe Zamor, Site 0022 704-355-6649
Charlotte, North Carolina, United States, 28204
Contact: Philipe Zamor, Site 0022 704-355-6649
United States, Pennsylvania
University of Pennsylvania
Philadephia, Pennsylvania, United States, 19104
Contact: Rajender Reddy, Site 0005 215-662-4311
University of Pennsylvania
Philadephia, Pennsylvania, United States, 19104
Contact: Rajender Reddy, Site 0005 215-662-4311
United States, Texas
Research Specialist of Texas
Houston, Texas, United States, 77030
Contact: Joseph Galati, Site 0003 713-634-5110
Research Specialist of Texas
Houston, Texas, United States, 77030
Contact: Joseph Galati, Site 0003 713-634-5110
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Contact: Richard Sterling, Site 0016 804-828-9034
Sponsors and Collaborators
Bristol-Myers Squibb
Additional Bristol-Myers Squibb (BMS) trials, here.
The HCV clinical trials in this post are not a complete list; to learn more about Hepatitis C virus clinical trials or to find out if a study is enrolling patients in your area, please click here.
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Contact: Richard Sterling, Site 0016 804-828-9034
Sponsors and Collaborators
Bristol-Myers Squibb
Additional Bristol-Myers Squibb (BMS) trials, here.
The HCV clinical trials in this post are not a complete list; to learn more about Hepatitis C virus clinical trials or to find out if a study is enrolling patients in your area, please click here.
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