Saturday, April 18, 2015

Recruiting Hepatitis C Clinical Trials-Gilead:Ledipasvir/Sofosbuvir And GS-9857 Plus Sofosbuvir/GS-5816

April Clinical trial updates. 

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.

Links
Visit HCV Advocate for more information on clinical trials listed by pharmaceutical company, for Gilead click here. In addition check out HCV drug pipeline for drugs currently in Phase 2 and 3 clinical development here, with comments here, and FDA approved medications for HCV here.

Contact
1-(800) GILEAD-5 (800-445-3235) between 8:00 a.m. and 5:00 p.m. Pacific Time.

Off The Cuff
This month, Gilead Sciences launched their first TV commercial, promoting Harvoni® (Ledipasvir/Sofosbuvir). 
Read more @ the blog of Dr. Joseph S. Galati.

Canada
This study is currently recruiting participants in some locations
Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination Tablet With Ribavirin for 12 Weeks in Treatment-naive Adults With Chronic HCV Genotype 3 Infection

ClinicalTrials.gov Identifier: NCT02413593

Purpose
This study will evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) plus ribavirin (RBV) in treatment-naive adults with chronic genotype 3 hepatitis C virus (HCV) infection.

Condition: Hepatitis C Virus Infection
Interventions: Drug: LDV/SOF; Drug: RBV
Sponsor: Gilead Sciences
Recruiting - verified April 2015

Contacts Contact: Gilead Study Team 337-1701@gilead.com 

Locations
Canada, Alberta
Not yet recruiting
Calgary, Alberta, Canada, T2N 4Z6
Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Not yet recruiting
Edmonton, Alberta, Canada, T5H 4B9
Canada, British Columbia
Not yet recruiting
Vancouver, British Columbia, Canada, V5Z 1H2
Not yet recruiting
Vancouver, British Columbia, Canada, V6Z 2K5
Not yet recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Ontario
Recruiting
Brampton, Ontario, Canada, L6R 3J7
Not yet recruiting
London, Ontario, Canada, N6A 5A5
Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Not yet recruiting
Toronto, Ontario, Canada, M6H 3M1
Not yet recruiting
Toronto, Ontario, Canada, M5T 2S8
Not yet recruiting
Vaughan, Ontario, Canada, L4L 4Y7
Canada, Quebec
Not yet recruiting
Montreal, Quebec, Canada, H2X 0A9
Not yet recruiting
Montreal, Quebec, Canada, H2L 4P9
Canada
Recruiting
Quebec, Canada, G1V 4G2

United States, New Zealand and Puerto Rico
This study is currently recruiting participants in all locations
Genotype 1
Safety and Efficacy of GS-9857 Plus Sofosbuvir/GS-5816 Fixed Dose Combination in Adults With Chronic Genotype 1 HCV Infection

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

Condition: Hepatitis C Virus Infection
Interventions: Drug: GS-9857; Drug: SOF/GS-5816
Sponsor: Gilead Sciences
Recruiting - verified April 2015

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

United States, New Zealand and Puerto Rico
This study is currently recruiting participants in all locations
Non-Genotype 1
Safety and Efficacy of GS-9857 Plus Sofosbuvir/GS-5816 Fixed Dose Combination in Adults With Chronic Non-Genotype 1 HCV Infection

ClinicalTrials.gov Identifier: NCT02378961

Condition: Hepatitis C Virus Infection
Interventions: Drug: GS-9857; Drug: SOF/GS-5816
Sponsor: Gilead Sciences
Recruiting - verified March 2015

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

New Zealand
This study is currently recruiting participants

ClinicalTrials.gov Identifier: NCT02202980

Condition: Chronic Hepatitis C
Interventions: Drug: LDV/SOF; Drug: RBV; Drug: GS-9857; Drug: SOF/GS-5816
Sponsor: Gilead Sciences
Recruiting - verified April 2015

Purpose
This study will evaluate the antiviral efficacy, safety, and tolerability of combination therapy with oral regimens for the treatment of chronic hepatitis C virus (HCV) infection.

Contacts
Contact: Raja Vakil raja.vakil@gilead.com

Locations
New Zealand
Recruiting
Auckland, New Zealand
Recruiting
Christchurch, New Zealand

Source

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