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Completed

NCT Number: NCT01356160

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Herston, Queensland, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GS-5885

Drug

tablet, 30 mg QD

GS-9451

Drug

tablet, 200 mg QD

peginterferon alfa-2a

Biological

(solution for injection) 180 µg/week

ribavirin tablet

Drug

ribavirin tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID)

GS-9451 placebo

Drug

Placebo to match GS-9451 QD

Primary outcomes

  1. To evaluate the antiviral efficacy of response guided therapy.

    Time frame: Through 24 weeks post-treatment

    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 outcomes

  1. To evaluate the safety and tolerability of each regimen.

    Time frame: Through 24 weeks post-treatment

    The primary safety endpoint is any AE leading to permanent discontinuation of study drugs.

  2. To characterize viral dynamics of GS-5885 and GS-9451 when administered with PEG and RBV.

    Time frame: Through Day 10 on study

    HCV RNA levels, pharmacokinetics and viral sequencing

  3. 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

    Plasma samples will be collected and stored at each visit for possible resistance analysis.

  4. To characterize steady state pharmacokinetics of GS-5885 and GS-9451 when administered with PEG and RBV.

    Time frame: Through 48 weeks of treatment

    Plasma concentrations of the study drug over time will be summarized using descriptive statistics.

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
May 19, 2011
Registry last updated
Feb 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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