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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01625338
First received: June 7, 2012
Last updated: October 9, 2015
Last verified: October 2015

June 7, 2012
October 9, 2015
June 2012
October 2014   (final data collection date for primary outcome measure)
  • Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) [ Time Frame: Posttreatment Week 12 ] [ Designated as safety issue: No ]
    SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.
  • Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event [ Time Frame: Up to 24 weeks ] [ 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
  • Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) [ Time Frame: Posttreatment Weeks 4 and 24 ] [ Designated as safety issue: No ]
    SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.
  • Percentage of Participants With On-treatment Virologic Failure [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]

    On-treatment virologic failure was defined as

    • Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
    • Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
    • Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)
  • Percentage of Participants With Viral Relapse [ Time Frame: Up to Posttreatment Week 24 ] [ Designated as safety issue: No ]
    Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment 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
This study will evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF; GS-7977) in combination with ribavirin (RBV) with or without pegylated interferon (Peg-IFN) in adults with chronic hepatitis C virus (HCV) infection 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: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Hepatitis C
  • Drug: SOF
    SOF 400 mg tablet administered orally once daily
    Other Names:
    • Sovaldi®
    • GS-7977
    • PSI-7977
  • Drug: RBV
    RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
  • Drug: Peg-IFN
    Peg-IFN 180 μg administered once weekly by subcutaneous injection
  • Experimental: SOF+RBV 12 Weeks
    SOF+RBV for 12 weeks
    Interventions:
    • Drug: SOF
    • Drug: RBV
  • Experimental: SOF+RBV 24 Weeks
    SOF+RBV for 24 weeks
    Interventions:
    • Drug: SOF
    • Drug: RBV
  • Experimental: SOF+RBV+Peg-IFN 12 Weeks
    SOF+RBV+Peg-IFN for 12 weeks
    Interventions:
    • Drug: SOF
    • Drug: RBV
    • Drug: Peg-IFN
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
534
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-IFN+RBV in a control arm
    • previously participated in a Gilead-sponsored HCV study and did not attain sustained virologic response 24 weeks after discontinuation of therapy (SVR24) on a regimen containing:

      • Sofosbuvir+RBV
      • Peg-IFN 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   (Adult, Senior)
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
Not Provided
Not Provided
Gilead Sciences
Gilead Sciences
Not Provided
Study Director: Bittoo Kanwar, MD Gilead Sciences
Gilead Sciences
October 2015

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