Open-Label Study of Sofusbuvir+Ribavirin With or Without Peginterferon Alfa-2a in Subjects With Chronic HCV Infection Who Participated in Prior Gilead HCV Studies

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01625338
First received: June 7, 2012
Last updated: February 13, 2014
Last verified: February 2014

June 7, 2012
February 13, 2014
June 2012
October 2014   (final data collection date for primary outcome measure)
  • Proportion of participants with sustained virologic response 12 weeks after discontinuation of therapy (SVR12) [ Time Frame: Post-treatment Week 12 ] [ Designated as safety issue: No ]
    SVR12 is defined as HCV RNA < the lower limit of quantification (LLOQ; ie, < 25 IU/mL) 12 weeks following the last dose of study medication.
  • Any adverse event (AE) leading to permanent discontinuation of study medication [ Time Frame: Baseline to Week 12 or 24 (depending on treatment arm) plus 30 days ] [ Designated as safety issue: No ]
  • Efficacy 12 weeks post dosing [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The proportion of patients with a sustained virologic response (SVR) 12 weeks after the end of treatment
  • Safety and tolerability of GS-7977 + RBV as measured by review of the accumulated safety data with any AE leading to permanent discontinuation of study drug(s) being of primary interest. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    The safety and tolerability of GS-7977 + RBV when given for 12 weeks as measured by review of the accumulated safety data
Complete list of historical versions of study NCT01625338 on ClinicalTrials.gov Archive Site
  • Proportion of participants with sustained virologic response 4 and 24 weeks after discontinuation of treatment (SVR4 and SVR 24) [ Time Frame: Post-treatment Weeks 4 and 24 ] [ Designated as safety issue: No ]
  • Proportion of participants with virologic failure [ Time Frame: Baseline to Post-treatment Week 24 ] [ Designated as safety issue: No ]

    Virologic failure will be measured by incidence of viral breakthrough.

    • Viral breakthrough is defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment, confirmed with 2 consecutive values (second confirmation value could be post-treatment), or last available on-treatment measurement with no subsequent follow-up values.

  • Proportion of participants with virologic relapse [ Time Frame: Baseline to Post-treatment Week 24 ] [ Designated as safety issue: No ]
    Viral relapse is defined as HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement.
  • Efficacy 4 and 24 weeks post dosing [ Time Frame: 4 and 24 weeks ] [ Designated as safety issue: No ]
    To determine the proportion of subjects who attain SVR at 4 and 24 weeks after discontinuation of therapy (SVR4 and SVR24)
  • Amount of circulating HCV RNA [ Time Frame: 12 weeks post dosing ] [ Designated as safety issue: No ]
    To evaluate the kinetics of circulating HCV RNA during treatment and after treatment discontinuation
  • Characterization of viral resistance [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    To evaluate the emergence of viral resistance to GS 7977 during treatment and after treatment discontinuation
Not Provided
Not Provided
 
Open-Label Study of Sofusbuvir+Ribavirin With or Without Peginterferon Alfa-2a in Subjects With Chronic HCV Infection Who Participated in Prior Gilead HCV Studies
An Open-Label Study of GS-7977 + Ribavirin With or Without Peginterferon Alfa-2a in Subjects With Chronic HCV Infection Who Participated in Prior Gilead HCV Studies

Open label study of sofosbuvir (GS-7977; PSI-7977) in combination with ribavirin (RBV) with or without Peginterferon Alfa-2a (PEG) in adults with chronic hepatitis C virus (HCV) who participated in a prior Gilead HCV study and have not achieved sustained virologic response (SVR).

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Hepatitis C
  • Drug: Sofosbuvir
    Sofosbuvir 400 mg tablet administered orally once daily
    Other Names:
    • GS-7977
    • PSI-7977
  • Drug: RBV
    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)
  • Drug: PEG
    Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection
  • Experimental: Sofosbuvir+RBV for 12 weeks
    Interventions:
    • Drug: Sofosbuvir
    • Drug: RBV
  • Experimental: Sofosbuvir+RBV for 24 weeks
    Interventions:
    • Drug: Sofosbuvir
    • Drug: RBV
  • Experimental: Sofosbuvir+RBV+PEG for 12 weeks
    Interventions:
    • Drug: Sofosbuvir
    • Drug: RBV
    • Drug: PEG
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
600
December 2014
October 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Infection with HCV
  • Must have participated in a prior Gilead HCV study
  • Use of highly effective contraception methods if female of childbearing potential or sexually active male
  • Eligible patients include those in the following

    • received placebo or PEG+RBV in a control arm
    • previously participated in a Gilead-sponsored HCV study and did not attain SVR24 on a regimen containing:

      • Sofosbuvir+RBV
      • PEG and/or RBV in combination with one or more Gilead investigational direct-acting agents

Exclusion Criteria:

  • Pregnant or nursing female or male with pregnant female partner
  • Current or prior history of clinical hepatic decompensation
  • Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
  • Chronic use of systemically administered immunosuppressive agents
  • Active drug abuse
  • Use of any prohibited concomitant medications
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Canada,   Czech Republic,   Estonia,   France,   Germany,   Italy,   Netherlands,   New Zealand,   Poland,   Puerto Rico,   Spain,   Sweden,   United Kingdom
 
NCT01625338
GS-US-334-0109, 2012-000571-16
Yes
Gilead Sciences
Gilead Sciences
Not Provided
Study Director: Bittoo Kanwar, MD Gilead Sciences
Gilead Sciences
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP