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GS-5885, GS-9451 With Peginterferon Alfa 2a (PEG) and Ribavirin in Treatment-Naïve Subjects With Chronic Genotype 1 Hep C Virus Infection and IL28B CC Genotype

Primary Purpose

Chronic Hepatitis C

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
GS-5885
GS-9451
RBV
PEG
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C focused on measuring Chronic Hepatitis C, IL28B CC Genotype, Treatment naive, Peginterferon α-2a (PEG), Genotype 1a/b, GS 9451, GS 5885, Ribavirin (RBV), HCV NS5A inhibitor, HCV NS3 protease inhibitor

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Males and females 18-70 years of age
  • Chronic HCV infection
  • Subjects must have liver biopsy results (≤ 3 years prior to screening) indicating the absence of cirrhosis. Alternatively a non-invasive alternative to liver biopsy (such as FibroTest, FibroScan, or Acoustic Radiation Force Impulse imaging) within 6 months of Screening in countries where allowed
  • Monoinfection with HCV genotype 1a or 1b
  • HCV RNA > 10^4 IU/mL at Screening
  • IL28B CC genotype
  • HCV treatment naïve
  • Candidate for PEG/RBV therapy
  • Body mass index (BMI) between 18 and 36 kg/m2
  • Creatinine clearance >= 50 mL/min
  • Agree to use two forms of highly effective contraception methods for the duration of the study and for 7 months after the last dose study medication. Females of childbearing potential must have negative pregnancy test at Screening and Baseline

Exclusion Criteria:

  • Exceed defined thresholds for key laboratory parameters at Screening
  • Diagnosis of autoimmune disease, decompensated liver disease, poorly controlled diabetes mellitus, significant psychiatric illness, severe chronic obstructive pulmonary disease (COPD), HIV, hepatitis B virus (HBV), hepatocellular carcinoma or other malignancy (with exception of certain skin cancers), hemoglobinopathy, retinal disease, or are immunosuppressed
  • Subjects with current use of amphetamines, cocaine, opiates (e.g., morphine, heroin), or ongoing alcohol abuse are excluded. Subjects on stable methadone maintenance treatment for at least 6 months prior to Screening may be included into the study
  • Use of prohibited concomitant medications two weeks prior to baseline through the end of treatment

Sites / Locations

  • Axis Clinical Trials
  • Axis Clinical Trials
  • UCLA Medical Center
  • V.A. Greater Los Angeles Healthcare System
  • UC Davis Medical Center
  • Research and Education, Inc.
  • San Jose Gastroenterology
  • Stanford University
  • South Denver Gastroenterology
  • Indianapolis Gastroenterology Research Foundation
  • Commonwealth Clinical Studies, LLC
  • Impact Clinical Trials
  • North Shore University Hospital
  • Weill Cornell College of Medicine
  • Westchester Medical Center
  • Asheville Gastroenterology Associates, P.A.
  • The University of North Carolina at Chapel Hill
  • Duke University
  • Oregon Health & Science University
  • The North Texas Research Institute
  • Research Specialists of Texas
  • University of Utah Pediatric Pulmonology
  • Metropolitan Liver Diseases Center
  • Liver Institute of Virginia, Bon Secours Health System
  • Digestive and Liver Disease Specialists
  • Harborview Medical Center
  • Royal Prince Alfred Hospital
  • Concord Repatriation General Hospital
  • Saint Vincents Hospital
  • Nepean Hospital
  • St. George Hospital
  • Liverpool Hospital
  • Westmead Hospital
  • Royal Brisbane Hospital Research Foundation
  • Greenslopes Private Hospital
  • Princess Alexandra Hospital
  • Flinders Medical Centre
  • St. Vincent's Hospital, Sydney Ltd.
  • Western Hospital
  • Austin Health, Department of Hepatology
  • Alfred Hospital
  • Monash Medical Centre
  • Box Hill Hospital
  • Royal Melbourne Hospital
  • Fremantle Hospital
  • Sir Charles Gairdner Hospital
  • University of Calgary
  • University of Alberta
  • LAIR Centre
  • GIRI GI Research Institute
  • University of Manitoba, John Buhler Research Centre
  • London Health Sciences
  • Toronto Liver Centre
  • Auckland Hospital
  • Waikato Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm 1

Arm 2

Arm Description

Response-Guided Therapy with GS-5885 30 mg plus GS-9451 200 mg, plus PEG and RBV for 6 or 12 weeks.

Response-Guided Therapy with PEG and RBV for 24 weeks.

Outcomes

Primary Outcome Measures

Sustained virologic response (SVR)
Sustained virologic response (SVR, defined as plasma HCV RNA < lower limit of quantification [LLoQ] at 24 weeks after treatment cessation) following treatment with GS-5885 + GS-9451 + PEG/RBV for 6 or 12 weeks, or PEG/RBV for 24 weeks in IL28B CC subjects.

Secondary Outcome Measures

Safety and tolerability of therapy
Safety and tolerability of the therapy is measured by frequency of laboratory abnormalities , reported adverse events and discontinuations due to adverse events.
Virologic response
Virologic response at Weeks 2, 4, 6, 8, 10, and 12 (depending on treatment arm) as measured by the rates of HCV RNA < LLoQ and viral breakthrough and relapse
Compare SVR
Compare SVR following treatment with GS-5885 + GS-9451 + PEG/RBV for 6 weeks versus 12 weeks.
Viral resistance
Characterize viral resistance to GS-5885 and GS-9451 when administered in combination with PEG/RBV

Full Information

First Posted
June 22, 2011
Last Updated
January 2, 2014
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01384383
Brief Title
GS-5885, GS-9451 With Peginterferon Alfa 2a (PEG) and Ribavirin in Treatment-Naïve Subjects With Chronic Genotype 1 Hep C Virus Infection and IL28B CC Genotype
Official Title
A Phase 2 Randomized, Open-Label, Exploratory Trial of GS-5885, GS-9451 With Peginterferon Alfa 2a and Ribavirin (RBV) in Treatment-Naïve Subjects With Chronic Genotype 1 Hepatitis C Virus Infection and IL28B CC Genotype
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Terminated
Study Start Date
August 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

5. Study Description

Brief Summary
This is a Phase 2, randomized, open-label exploratory study that will examine the antiviral efficacy, safety, and tolerability of Response guided treatment (RGT) with GS-5885 + GS-9451 + PEG/RBV (6 or 12 weeks), or Peginterferon Alfa 2a (PEG)/Ribavirin (RBV)alone (24 weeks) in treatment naïve subjects with chronic Hep C (HCV) infection with genotype (GT) 1 and IL28B CC genotype.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C
Keywords
Chronic Hepatitis C, IL28B CC Genotype, Treatment naive, Peginterferon α-2a (PEG), Genotype 1a/b, GS 9451, GS 5885, Ribavirin (RBV), HCV NS5A inhibitor, HCV NS3 protease inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
248 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Response-Guided Therapy with GS-5885 30 mg plus GS-9451 200 mg, plus PEG and RBV for 6 or 12 weeks.
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
Response-Guided Therapy with PEG and RBV for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
GS-5885
Intervention Description
GS-5885 30 mg tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
GS-9451
Intervention Description
GS-9451 200 mg tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
RBV
Intervention Description
Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
Intervention Type
Drug
Intervention Name(s)
PEG
Intervention Description
Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection
Primary Outcome Measure Information:
Title
Sustained virologic response (SVR)
Description
Sustained virologic response (SVR, defined as plasma HCV RNA < lower limit of quantification [LLoQ] at 24 weeks after treatment cessation) following treatment with GS-5885 + GS-9451 + PEG/RBV for 6 or 12 weeks, or PEG/RBV for 24 weeks in IL28B CC subjects.
Time Frame
30 , 36 or 48 weeks
Secondary Outcome Measure Information:
Title
Safety and tolerability of therapy
Description
Safety and tolerability of the therapy is measured by frequency of laboratory abnormalities , reported adverse events and discontinuations due to adverse events.
Time Frame
Up to 48 weeks
Title
Virologic response
Description
Virologic response at Weeks 2, 4, 6, 8, 10, and 12 (depending on treatment arm) as measured by the rates of HCV RNA < LLoQ and viral breakthrough and relapse
Time Frame
Weeks 2, 4, 6, 8, 10, and 12
Title
Compare SVR
Description
Compare SVR following treatment with GS-5885 + GS-9451 + PEG/RBV for 6 weeks versus 12 weeks.
Time Frame
Weeks 30 and 36
Title
Viral resistance
Description
Characterize viral resistance to GS-5885 and GS-9451 when administered in combination with PEG/RBV
Time Frame
Up to 96 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males and females 18-70 years of age Chronic HCV infection Subjects must have liver biopsy results (≤ 3 years prior to screening) indicating the absence of cirrhosis. Alternatively a non-invasive alternative to liver biopsy (such as FibroTest, FibroScan, or Acoustic Radiation Force Impulse imaging) within 6 months of Screening in countries where allowed Monoinfection with HCV genotype 1a or 1b HCV RNA > 10^4 IU/mL at Screening IL28B CC genotype HCV treatment naïve Candidate for PEG/RBV therapy Body mass index (BMI) between 18 and 36 kg/m2 Creatinine clearance >= 50 mL/min Agree to use two forms of highly effective contraception methods for the duration of the study and for 7 months after the last dose study medication. Females of childbearing potential must have negative pregnancy test at Screening and Baseline Exclusion Criteria: Exceed defined thresholds for key laboratory parameters at Screening Diagnosis of autoimmune disease, decompensated liver disease, poorly controlled diabetes mellitus, significant psychiatric illness, severe chronic obstructive pulmonary disease (COPD), HIV, hepatitis B virus (HBV), hepatocellular carcinoma or other malignancy (with exception of certain skin cancers), hemoglobinopathy, retinal disease, or are immunosuppressed Subjects with current use of amphetamines, cocaine, opiates (e.g., morphine, heroin), or ongoing alcohol abuse are excluded. Subjects on stable methadone maintenance treatment for at least 6 months prior to Screening may be included into the study Use of prohibited concomitant medications two weeks prior to baseline through the end of treatment
Facility Information:
Facility Name
Axis Clinical Trials
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Axis Clinical Trials
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
V.A. Greater Los Angeles Healthcare System
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Research and Education, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92105
Country
United States
Facility Name
San Jose Gastroenterology
City
San Jose
State/Province
California
ZIP/Postal Code
95116
Country
United States
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94035
Country
United States
Facility Name
South Denver Gastroenterology
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Indianapolis Gastroenterology Research Foundation
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
Commonwealth Clinical Studies, LLC
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02302
Country
United States
Facility Name
Impact Clinical Trials
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
North Shore University Hospital
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Weill Cornell College of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Westchester Medical Center
City
Yonkers
State/Province
New York
ZIP/Postal Code
10701
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
The University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
The North Texas Research Institute
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Research Specialists of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Utah Pediatric Pulmonology
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84143
Country
United States
Facility Name
Metropolitan Liver Diseases Center
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Liver Institute of Virginia, Bon Secours Health System
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
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Concord Repatriation General Hospital
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2137
Country
Australia
Facility Name
Saint Vincents Hospital
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Nepean Hospital
City
Kingswood
State/Province
New South Wales
ZIP/Postal Code
2747
Country
Australia
Facility Name
St. George Hospital
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
NSW 2217
Country
Australia
Facility Name
Liverpool Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
1871
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Royal Brisbane Hospital Research Foundation
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Greenslopes Private Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Flinders Medical Centre
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
St. Vincent's Hospital, Sydney Ltd.
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Western Hospital
City
Footscray
State/Province
Victoria
ZIP/Postal Code
VIC 3011
Country
Australia
Facility Name
Austin Health, Department of Hepatology
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3081
Country
Australia
Facility Name
Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Monash Medical Centre
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Box Hill Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Fremantle Hospital
City
Fremantle
State/Province
Western Australia
ZIP/Postal Code
6160
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N4N1
Country
Canada
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2C8
Country
Canada
Facility Name
LAIR Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1H2
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, John Buhler Research Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 3P4
Country
Canada
Facility Name
London Health Sciences
City
London
State/Province
Ontario
ZIP/Postal Code
N6A5A5
Country
Canada
Facility Name
Toronto Liver Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6H 3M1
Country
Canada
Facility Name
Auckland Hospital
City
Aukland
Country
New Zealand
Facility Name
Waikato Hospital
City
Hamilton
ZIP/Postal Code
3240
Country
New Zealand

12. IPD Sharing Statement

Learn more about this trial

GS-5885, GS-9451 With Peginterferon Alfa 2a (PEG) and Ribavirin in Treatment-Naïve Subjects With Chronic Genotype 1 Hep C Virus Infection and IL28B CC Genotype

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