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Sofosbuvir + Ribavirin for 12 Weeks in Subjects With Chronic Genotype 2 or 3 Hepatitis C Infection Who Are Interferon Intolerant, Interferon Ineligible or Unwilling to Take Interferon (POSITRON)

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ClinicalTrials.gov Identifier: NCT01542788
Recruitment Status : Completed
First Posted : March 2, 2012
Results First Posted : February 17, 2014
Last Update Posted : May 19, 2014
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Tracking Information
First Submitted Date  ICMJE February 17, 2012
First Posted Date  ICMJE March 2, 2012
Results First Submitted Date  ICMJE January 6, 2014
Results First Posted Date  ICMJE February 17, 2014
Last Update Posted Date May 19, 2014
Study Start Date  ICMJE March 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2014)
  • Percentage of Participants Achieving SVR12 [ Time Frame: Post-treatment Week 12 ]
    SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ, ie, < 25 IU/mL) 12 weeks after cessation of therapy
  • Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug [ Time Frame: Baseline to Week 12 ]
    The number of subjects experiencing adverse events leading to permanent discontinuation of study drug was summarized. Adverse events may or may not have been related to study treatment.
Original Primary Outcome Measures  ICMJE
 (submitted: March 1, 2012)
  • Efficacy 12 weeks post dosing [ Time Frame: 12 weeks ]
    The proportion of patients with a sustained virologic response (SVR) 12 weeks after the end of treatment
  • Description of Safety with GS-7977 and ribavirin [ Time Frame: 12 Weeks ]
    The safety and tolerability of GS 7977 + RBV compared to placebo
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 6, 2014)
  • Percentage of Participants Achieving SVR4 [ Time Frame: Post-treatment Week 4 ]
    SVR4 was defined as HCV RNA < LLOQ 4 weeks after cessation of therapy
  • Percentage of Participants Achieving SVR24 [ Time Frame: Post-treatment Week 24 ]
    SVR24 was defined as HCV RNA < LLOQ 24 weeks after cessation of therapy
  • Percentage of Participants Experiencing Viral Breakthrough [ Time Frame: Baseline to Week 12 ]
    Viral breakthrough was 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 posttreatment), or last available on-treatment measurement with no subsequent follow-up values
  • Percentage of Participants Experiencing Viral Relapse [ Time Frame: End of treatment to post-treatment Week 24 ]
    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
Original Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2012)
  • Efficacy 4 and 24 weeks post dosing [ Time Frame: 4 weeks and 24 weeks ]
    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 ]
    To evaluate the kinetics of circulating HCV RNA during treatment and after treatment discontinuation
  • Characterization of viral resistance [ Time Frame: 12 weeks ]
    To evaluate the emergence of viral resistance to GS 7977 during treatment and after treatment discontinuation
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sofosbuvir + Ribavirin for 12 Weeks in Subjects With Chronic Genotype 2 or 3 Hepatitis C Infection Who Are Interferon Intolerant, Interferon Ineligible or Unwilling to Take Interferon
Official Title  ICMJE A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GS-7977 + Ribavirin for 12 Weeks in Subjects With Chronic Genotype 2 or 3 HCV Infection Who Are Interferon Intolerant, Interferon Ineligible or Unwilling to Take Interferon
Brief Summary This multicenter study was to evaluate subjects with chronic genotype 2 or 3 HCV infection who were interferon (IFN) ineligible, IFN intolerant or unwilling to take IFN. Participants were randomized in a 3:1 ratio to receive sofosbuvir (SOF)+ribavirin (RBV), or placebo to match SOF+placebo to match RBV. Randomization was stratified by presence/absence of cirrhosis. Approximately 20% of participants may have had evidence of cirrhosis at screening.
Detailed Description

Participants who were randomized to the placebo arm and completed all scheduled study procedures were eligible to receive active SOF+RBV in open-label Study GS-US-334-0109.

Participants who do not achieve sustained virologic response (SVR) were eligible for enrollment in the Sequence Registry Study GS-US-248-0123. The purpose of the Sequence Registry Study is to monitor the persistence of resistant mutations for up to 3 years.

Participants who achieved SVR were eligible for enrollment in the SVR Registry Study GS-US-248-0122. The purpose of the SVR Registry Study is to evaluate durability of SVR for up to 3 years after treatment.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Hepatitis C
Intervention  ICMJE
  • Drug: SOF
    Sofosbuvir (SOF) 400 mg tablet administered orally once daily
    Other Names:
    • Sovaldi®
    • GS-7977
    • PSI-7977
  • Drug: RBV
    Ribavirin (RBV) was administered as a tablet orally according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg).
  • Drug: Placebo to match SOF
    Placebo to match SOF was administered orally once daily.
  • Drug: Placebo to match RBV
    Placebo to match RBV was administered orally twice daily.
Study Arms  ICMJE
  • Experimental: SOF+RBV
    Participants were randomized to receive SOF+RBV for 12 weeks.
    Interventions:
    • Drug: SOF
    • Drug: RBV
  • Placebo Comparator: Placebo
    Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks.
    Interventions:
    • Drug: Placebo to match SOF
    • Drug: Placebo to match RBV
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 6, 2014)
278
Original Estimated Enrollment  ICMJE
 (submitted: March 1, 2012)
240
Actual Study Completion Date  ICMJE February 2013
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Infection with HCV genotype 2 or 3
  • Cirrhosis determination
  • Subject meets one of the following classifications:

    1. IFN unwilling
    2. IFN ineligible
    3. IFN intolerant
  • Screening laboratory values within defined thresholds
  • Subject has not been treated with any investigational drug or device within 30 days of the Screening visit
  • Use of highly effective contraception methods if female of childbearing potential or sexually active male

Exclusion Criteria:

  • Prior exposure to an direct-acting antiviral targeting the HCV nonstructural protein (NS)5B polymerase
  • Pregnant or nursing female or male with pregnant female partner
  • Current or prior history of clinical hepatic decompensation
  • History of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
  • Excessive alcohol ingestion or significant drug abuse
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   New Zealand,   Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01542788
Other Study ID Numbers  ICMJE GS-US-334-0107
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gilead Sciences
Study Sponsor  ICMJE Gilead Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Gilead Sciences
Verification Date May 2014

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