Back to resultsGS-5885, GS-9451, Tegobuvir and Ribavirin (RBV) in Interferon Ineligible or Intolerant Subjects With Chronic Genotype 1a or 1b Hepatitis C Virus (HCV) Infection
Primary Purpose
Chronic Genotype 1a or 1b HCV Infection
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
GS-5885 tablet
GS-9451 tablet
tegobuvir capsule
ribavirin tablet
placebo matching ribavirin tablet
placebo matching tegobuvir capsule
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Genotype 1a or 1b HCV Infection focused on measuring Hepatitis C, HCV, Rapid Virologic Response, Sustained Virologic Response, Direct Acting Antiviral, Combination Therapy, Tegobuvir, Treatment naïve, HCV RNA, Polymerase inhibitor, Protease inhibitor, Interferon intolerant, Interferon ineligible, GS-9190, GS-9451, GS-5885
Eligibility Criteria
Inclusion Criteria:
- Adult subjects 18 and older with chronic HCV infection
- Liver biopsy results (performed no more than 3 years prior to Screening) indicating the absence of cirrhosis
- Monoinfection with HCV genotype 1a or 1b
- Interferon ineligible or intolerant
- Body mass index (BMI) between 18 and 40 kg/m2
- Use of highly effective contraception methods if female of childbearing potential or sexually active male
- Screening laboratory values within defined thresholds
- Has not been exposed to any investigational drug or device within 30 days of the Screening visit
- Able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments
Exclusion Criteria:
- Prior treatment of HCV with any direct-acting antiviral (whether approved or experimental)
- Decompensated liver disease or cirrhosis
- Co-infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or another HCV genotype
- History of difficulty with blood collection and/or poor venous access
- Pregnant or nursing female or male with pregnant female partner
- Chronic liver disease of a non-HCV etiology
- Suspicion of hepatocellular carcinoma
- Clinically-relevant drug abuse
Sites / Locations
- California Liver Institute
- SCTI Research Foundation Liver Center
- Scripps Clinic
- University of California, San Diego
- Kaiser Permanente Medical Center
- Lightsource Medical
- Medical Associates Research Group, Inc.
- Kaiser Permanente
- California Pacific Medical Center
- University of Colorado
- University of Miami, Center for Liver Diseases
- Orlando Immunology Center (ACH)
- Gastrointestinal Specialists of Georgia, PC
- Indianapolis Gastroenterology Research Foundation
- University of Kansas Medical Center
- Johns Hopkins University
- Massachusetts General Hospital
- Beth Israel Deconess Medical Center
- The Research Institute
- Henry Ford Health System
- Saint Michael's Medical Center
- Weill Cornell Medical College
- Asheville Gastroenterology Associates, P.A.
- University of North Carolina at Chapel Hill
- University of Pennsylvania
- Thomas Jefferson University Hospital
- University Gastroenterology
- Gastro One
- The North Texas Research Institute
- The University of Texas Medical Branch
- The University of Texas Health Sciences Center at Houston
- Alamo Medical Research
- Inova Fairfax Hospital Center for Liver Diseases
- Bon Secours St. Mary's Hospital of Richmond, Inc.
- Digestive and Liver Disease Specialists
- Virginia Mason Medical Center
- University of Calgary
- University Of Alberta Hospital
- University of Alberta
- Gordon & Leslie Diamond Health Care Centre
- University of British Columbia
- GIRI GI Research Institute
- University of Manitoba
- London Health Sciences Centre
- The Ottawa Hospital
- Toronto General Hospital, University Health Network
- Toronto General Hospital, University Health Network
- Toronto Western Hospital
- Hospital Saint-Luc DU CHUM
- Clinical Research Puerto Rico Inc
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Arm 1
Arm 2
Arm 3
Arm Description
GS-5885, GS-9451, tegobuvir (GS-9190), and Copegus® for 24 weeks
GS-5885, GS-9451, tegobuvir (GS-9190), and a placebo matching ribavirin for 24 weeks
GS-5885, GS-9451, a placebo matching tegobuvir, and Copegus® for 24 weeks
Outcomes
Primary Outcome Measures
Safety and Tolerability
To evaluate safety and tolerability of combination therapy with GS-5885, GS-9451, tegobuvir and ribavirin or GS-5885, GS-9451 and tegobuvir or GS-5885, GS-9451 and ribavirin. Safety will be assessed during the study through the reporting of adverse events, clinical laboratory tests, physical examinations, vital signs and 12-lead ECGs at various time points during the study.
Antiviral Activity
To evaluate antiviral efficacy as measured by sustained virologic response (defined as HCV RNA < lower limit of quantitation 24-weeks post-treatment) of combination therapy with GS-5885, GS-9451, tegobuvir and ribavirin or GS-5885, GS-9451 and tegobuvir or GS-5885, GS-9451 and ribavirin.
Secondary Outcome Measures
Viral Dynamics
To characterize the viral dynamics of GS-5885, GS-9451 and tegobuvir. The median change from baseline in HCV RNA and time-weighted average change from baseline through Day 10 will be assessed based on plasma HCV RNA sampling times to characterize the viral dynamics of GS-5885, GS-9451 and tegobuvir.
Composite (or Profile) of Pharmacokinetics
To characterize the steady state pharmacokinetics of GS-5885, GS-9451, tegobuvir and ribavirin (if appropriate). Cmax, Tmax, Clast, Tlast, Ctau, λz, AUCtau and T ½
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01434498
Brief Title
GS-5885, GS-9451, Tegobuvir and Ribavirin (RBV) in Interferon Ineligible or Intolerant Subjects With Chronic Genotype 1a or 1b Hepatitis C Virus (HCV) Infection
Official Title
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of GS-5885, GS-9451, Tegobuvir and Ribavirin; GS-5885, GS-9451 and Tegobuvir; GS-5885, GS-9451 and Ribavirin in Interferon Ineligible or Intolerant Subjects With Chronic Genotype 1a or 1b HCV Infection (Protocol No. GS US 248 0132)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of GS-5885, GS-9451, Tegobuvir and Ribavirin; GS-5885, GS-9451 and Tegobuvir; GS-5885, GS-9451 and Ribavirin in Interferon Ineligible or Intolerant Subjects with Chronic Genotype 1a or 1b HCV Infection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Genotype 1a or 1b HCV Infection
Keywords
Hepatitis C, HCV, Rapid Virologic Response, Sustained Virologic Response, Direct Acting Antiviral, Combination Therapy, Tegobuvir, Treatment naïve, HCV RNA, Polymerase inhibitor, Protease inhibitor, Interferon intolerant, Interferon ineligible, GS-9190, GS-9451, GS-5885
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
163 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Active Comparator
Arm Description
GS-5885, GS-9451, tegobuvir (GS-9190), and Copegus® for 24 weeks
Arm Title
Arm 2
Arm Type
Active Comparator
Arm Description
GS-5885, GS-9451, tegobuvir (GS-9190), and a placebo matching ribavirin for 24 weeks
Arm Title
Arm 3
Arm Type
Active Comparator
Arm Description
GS-5885, GS-9451, a placebo matching tegobuvir, and Copegus® for 24 weeks
Intervention Type
Drug
Intervention Name(s)
GS-5885 tablet
Intervention Description
GS-5885 tablet, 90 mg, QD
Intervention Type
Drug
Intervention Name(s)
GS-9451 tablet
Intervention Description
GS-9451 tablet, 200 mg QD
Intervention Type
Drug
Intervention Name(s)
tegobuvir capsule
Intervention Description
tegobuvir capsule, 30 mg BID
Intervention Type
Drug
Intervention Name(s)
ribavirin tablet
Intervention Description
ribavirin tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID)
Intervention Type
Drug
Intervention Name(s)
placebo matching ribavirin tablet
Intervention Description
placebo matching ribavirin tablet, BID
Intervention Type
Device
Intervention Name(s)
placebo matching tegobuvir capsule
Intervention Description
placebo matching tegobuvir capsule, BID
Primary Outcome Measure Information:
Title
Safety and Tolerability
Description
To evaluate safety and tolerability of combination therapy with GS-5885, GS-9451, tegobuvir and ribavirin or GS-5885, GS-9451 and tegobuvir or GS-5885, GS-9451 and ribavirin. Safety will be assessed during the study through the reporting of adverse events, clinical laboratory tests, physical examinations, vital signs and 12-lead ECGs at various time points during the study.
Time Frame
Through 24 weeks of off-treatment follow-up
Title
Antiviral Activity
Description
To evaluate antiviral efficacy as measured by sustained virologic response (defined as HCV RNA < lower limit of quantitation 24-weeks post-treatment) of combination therapy with GS-5885, GS-9451, tegobuvir and ribavirin or GS-5885, GS-9451 and tegobuvir or GS-5885, GS-9451 and ribavirin.
Time Frame
Through 24 weeks of off-treatment follow-up
Secondary Outcome Measure Information:
Title
Viral Dynamics
Description
To characterize the viral dynamics of GS-5885, GS-9451 and tegobuvir. The median change from baseline in HCV RNA and time-weighted average change from baseline through Day 10 will be assessed based on plasma HCV RNA sampling times to characterize the viral dynamics of GS-5885, GS-9451 and tegobuvir.
Time Frame
Through 10 days of therapy
Title
Composite (or Profile) of Pharmacokinetics
Description
To characterize the steady state pharmacokinetics of GS-5885, GS-9451, tegobuvir and ribavirin (if appropriate). Cmax, Tmax, Clast, Tlast, Ctau, λz, AUCtau and T ½
Time Frame
predose, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult subjects 18 and older with chronic HCV infection
Liver biopsy results (performed no more than 3 years prior to Screening) indicating the absence of cirrhosis
Monoinfection with HCV genotype 1a or 1b
Interferon ineligible or intolerant
Body mass index (BMI) between 18 and 40 kg/m2
Use of highly effective contraception methods if female of childbearing potential or sexually active male
Screening laboratory values within defined thresholds
Has not been exposed to any investigational drug or device within 30 days of the Screening visit
Able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments
Exclusion Criteria:
Prior treatment of HCV with any direct-acting antiviral (whether approved or experimental)
Decompensated liver disease or cirrhosis
Co-infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or another HCV genotype
History of difficulty with blood collection and/or poor venous access
Pregnant or nursing female or male with pregnant female partner
Chronic liver disease of a non-HCV etiology
Suspicion of hepatocellular carcinoma
Clinically-relevant drug abuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John McNally, PhD
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
California Liver Institute
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
SCTI Research Foundation Liver Center
City
Coronado
State/Province
California
ZIP/Postal Code
92118
Country
United States
Facility Name
Scripps Clinic
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
University of California, San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92161
Country
United States
Facility Name
Kaiser Permanente Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Lightsource Medical
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Medical Associates Research Group, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Kaiser Permanente
City
San Diego
State/Province
California
ZIP/Postal Code
92154
Country
United States
Facility Name
California Pacific Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Miami, Center for Liver Diseases
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Orlando Immunology Center (ACH)
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803-1851
Country
United States
Facility Name
Gastrointestinal Specialists of Georgia, PC
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Indianapolis Gastroenterology Research Foundation
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Johns Hopkins University
City
Lutherville
State/Province
Maryland
ZIP/Postal Code
21093
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
The Research Institute
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01105
Country
United States
Facility Name
Henry Ford Health System
City
Novi
State/Province
Michigan
ZIP/Postal Code
48377
Country
United States
Facility Name
Saint Michael's Medical Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07102
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Asheville Gastroenterology Associates, P.A.
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
University Gastroenterology
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Facility Name
Gastro One
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
The North Texas Research Institute
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
The University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
The University of Texas Health Sciences Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Alamo Medical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Inova Fairfax Hospital Center for Liver Diseases
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Bon Secours St. Mary's Hospital of Richmond, Inc.
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23602
Country
United States
Facility Name
Digestive and Liver Disease Specialists
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
University Of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2C8
Country
Canada
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2X8
Country
Canada
Facility Name
Gordon & Leslie Diamond Health Care Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2C9
Country
Canada
Facility Name
GIRI GI Research Institute
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2K5
Country
Canada
Facility Name
University of Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 3P4
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Toronto General Hospital, University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
Toronto General Hospital, University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T2S8
Country
Canada
Facility Name
Hospital Saint-Luc DU CHUM
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X3J4
Country
Canada
Facility Name
Clinical Research Puerto Rico Inc
City
San Juan
ZIP/Postal Code
00909-1711
Country
Puerto Rico
12. IPD Sharing Statement
Learn more about this trial
GS-5885, GS-9451, Tegobuvir and Ribavirin (RBV) in Interferon Ineligible or Intolerant Subjects With Chronic Genotype 1a or 1b Hepatitis C Virus (HCV) Infection
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