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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01356160
First received: May 2, 2011
Last updated: March 7, 2013
Last verified: March 2013
History of Changes
  Purpose

This is a Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Response Guided Therapy with GS-5885 Alone or in Combination with GS-9451 with Peginterferon Alfa 2a and Ribavirin in Treatment Naïve Subjects with Chronic Genotype 1 Hepatitis C Virus Infection.


Condition Intervention Phase
Hepatitis C, Chronic
 Drug: GS-5885
Drug: GS-9451
Biological: peginterferon alfa-2a
Drug: ribavirin tablet
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Response Guided Therapy With GS-5885 Alone or in Combination With GS-9451 With Peginterferon Alfa 2a and Ribavirin in Treatment Naïve Subjects With Chronic Genotype 1 Hepatitis C Virus Infection

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • To evaluate the antiviral efficacy of response guided therapy. [ Time Frame: Through 24 weeks post-treatment ] [ Designated as safety issue: No ]
    To evaluate the antiviral efficacy as measured by sustained virologic response (SVR, defined as plasma HCV RNA < Lower Limit of Quantification (LLoQ) at 24 weeks post-treatment) of response guided therapy (RGT) with GS-5885 + GS-9451 + PEG/RBV, or GS-5885 + PEG/RBV.


Secondary Outcome Measures:
  • To evaluate the safety and tolerability of each regimen. [ Time Frame: Through 24 weeks post-treatment ] [ Designated as safety issue: No ]
    The primary safety endpoint is any AE leading to permanent discontinuation of study drugs.

  • To characterize viral dynamics of GS-5885 and GS-9451 when administered with PEG and RBV. [ Time Frame: Through Day 10 on study ] [ Designated as safety issue: No ]
    HCV RNA levels, pharmacokinetics and viral sequencing

  • To characterize the viral resistance to GS-5885 and GS-9451 when administered in combination with PEG and RBV. [ Time Frame: 12 or 24 weeks ] [ Designated as safety issue: No ]
    Plasma samples will be collected and stored at each visit for possible resistance analysis.

  • To characterize steady state pharmacokinetics of GS-5885 and GS-9451 when administered with PEG and RBV. [ Time Frame: Through 48 weeks of treatment ] [ Designated as safety issue: No ]
    Plasma concentrations of the study drug over time will be summarized using descriptive statistics.


Enrollment: 351
Study Start Date: July 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1
RGT with GS-5885 30 mg QD + GS-9451 200 mg QD + PEG/RBV
 Drug: GS-5885
tablet, 30 mg QD
Drug: GS-9451
tablet, 200 mg QD
Biological: peginterferon alfa-2a
(solution for injection) 180 µg/week
Drug: ribavirin tablet
ribavirin tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID)
Placebo Comparator: Arm 2
RGT with GS-5885 30 mg QD + GS-9451 placebo QD + PEG/RBV
 Drug: GS-5885
tablet, 30 mg QD
Biological: peginterferon alfa-2a
(solution for injection) 180 µg/week
Drug: ribavirin tablet
ribavirin tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID)
Drug: GS-9451
tablet, placebo QD

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females 18-70 years of age
  • Chronic HCV infection
  • Subjects must have liver biopsy results (≤ 2 years prior to Screening) indicating the absence of cirrhosis.
  • Monoinfection with HCV genotype 1
  • HCV RNA > 10^4 IU/mL at Screening
  • HCV treatment naïve
  • Candidate for PEG/RBV therapy
  • Body mass index (BMI) 18-36 kg/m2, inclusive
  • Agree to use two forms of highly effective contraception methods for the duration of the study and for 7 months after the last dose of study medication. Females of childbearing potential must have negative pregnancy test at Screening and Baseline.

Exclusion Criteria:

  • Pregnant female or male with pregnant female partner
  • Exceed defined thresholds for leukopenia, neutropenia, anemia, thrombocytopenia, thyroid stimulating hormone (TSH)
  • 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 resolved 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. Patients on stable methadone or buprenorphine maintenance treatment for at least 6 months prior to Screening may be included into the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01356160

  Show 23 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Chair: Diana Brainard, MD Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01356160     History of Changes
Other Study ID Numbers: GS-US-256-0148
Study First Received: May 2, 2011
Last Updated: March 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
Hepatitis C
HCV
Rapid Virologic Response
Sustained Virologic Response
Direct Acting Antiviral
 Combination Therapy HCV RNA
Protease inhibitor
Treatment naïve
GS-5885
GS-9451

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
 Hepatitis, Chronic
Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013