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Efficacy and Safety of Sofosbuvir Plus Ribavirin in Adults With Chronic HCV Infection

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ClinicalTrials.gov Identifier: NCT02021643
Recruitment Status : Completed
First Posted : December 27, 2013
Results First Posted : February 20, 2018
Last Update Posted : February 20, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Tracking Information
First Submitted Date  ICMJE November 26, 2013
First Posted Date  ICMJE December 27, 2013
Results First Submitted Date  ICMJE August 11, 2017
Results First Posted Date  ICMJE February 20, 2018
Last Update Posted Date February 20, 2018
Actual Study Start Date  ICMJE December 10, 2013
Actual Primary Completion Date August 12, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 11, 2017)
  • Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) [ Time Frame: Posttreatment Week 12 ]
    SVR12 is defined as HCV RNA < the lower limit of quantification (LLOQ; ie, < 25 IU/mL) 12 weeks following the last dose of study drug.
  • Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event [ Time Frame: Up to 24 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 20, 2013)
  • Proportion of participants with sustained virologic response 12 weeks after discontinuation of therapy (SVR12) [ Time Frame: Post-treatment Week 12 ]
    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.
  • Proportion of participants experiencing an adverse event (AE) leading to permanent discontinuation of study medication [ Time Frame: Baseline to Week 12, 16, or 24 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 11, 2017)
  • Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) [ Time Frame: Posttreatment Weeks 4 and 24 ]
    SVR4 and SVR24 are defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.
  • Percentage of Participants With On-Treatment Virologic Failure [ Time Frame: Up to 24 weeks ]
    Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment.
  • Percentage of Participants With Viral Relapse [ Time Frame: Up to Posttreatment Week 24 ]
    Viral relapse was 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.
  • Change From Baseline in HCV RNA (log10 IU/mL) [ Time Frame: Up to 24 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2013)
  • Proportion of participants with: HCV RNA < LLOQ at 4 and 24 weeks after discontinuation of therapy (SVR4 and SVR24) [ Time Frame: Post-treatment Weeks 4 and 24 ]
  • Proportion of participants experiencing viral breakthrough [ Time Frame: Baseline to Week 12, 16, or 24 ]
    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.
  • Proportion of participants experiencing viral relapse [ Time Frame: Week 12, 16, or 24 to post-treatment Week 24 ]
    Viral relapse was 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 posttreatment measurement.
  • Change From Baseline in HCV RNA (log10 IU/mL) [ Time Frame: Baseline to post-treatment Week 24 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Sofosbuvir Plus Ribavirin in Adults With Chronic HCV Infection
Official Title  ICMJE A Phase 3b, Multicenter, Open-Label, Randomized Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin (± Pegylated Interferon) in Subjects With Chronic Genotype 1, 2, 3 and 6 HCV Infection
Brief Summary The primary objectives of this study are to evaluate the efficacy, safety and tolerability of treatment with sofosbuvir (SOF)+ ribavirin (RBV), with or without Pegylated interferon alfa (Peg-IFNα-2a/ PEG)) in participants with chronic genotype (GT)-1, 2, 3, and 6 Hepatitis C virus (HCV) infection.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic HCV Infection
Intervention  ICMJE
  • Drug: Sofosbuvir
    Sofosbuvir 400 mg tablet administered orally once daily
    Other Names:
    • Sovaldi®
    • 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)
    Other Name: Ribasphere®
  • Drug: PEG
    Pegylated interferon alfa-2a (Peg-IFNα-2a) 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week
    Other Name: Pegasys®
Study Arms  ICMJE
  • Experimental: Sofosbuvir+RBV+PEG 12 weeks
    Participants with genotype 1 or 6 will receive sofosbuvir+RBV+Peg-IFNα-2a for 12 weeks.
    Interventions:
    • Drug: Sofosbuvir
    • Drug: RBV
    • Drug: PEG
  • Experimental: Sofosbuvir+RBV 12 weeks
    Participants with genotype 1, 2 or 6 will receive sofosbuvir+RBV for 12 weeks.
    Interventions:
    • Drug: Sofosbuvir
    • Drug: RBV
  • Experimental: Sofosbuvir+RBV 16 weeks
    Participants with genotype 1, 6 will receive sofosbuvir+RBV for 16 weeks.
    Interventions:
    • Drug: Sofosbuvir
    • Drug: RBV
  • Experimental: Sofosbuvir+RBV 24 Weeks
    Participants with genotype 1, 3, or 6 will receive sofosbuvir+RBV for 24 weeks.
    Interventions:
    • Drug: Sofosbuvir
    • Drug: 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: December 24, 2015)
687
Original Estimated Enrollment  ICMJE
 (submitted: December 20, 2013)
450
Actual Study Completion Date  ICMJE November 3, 2016
Actual Primary Completion Date August 12, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Willing and able to provide written informed consent
  • HCV RNA ≥ 10^4 IU/mL at screening
  • HCV treatment-naive (HCV genotype 1, 2, 3 or 6), defined as no prior exposure to any interferon (IFN), RBV, or other approved or experimental HCV-specific direct-acting antiviral agent, or HCV treatment-experienced (HCV genotype 1, 2, 3, or 6 only) with medical records that include sufficient detail of prior treatment with IFN to allow for categorization of prior response as either IFN Intolerant, non-responder, or experiences viral breakthrough or relapse
  • HCV infection documented by anti-HCV antibody test, genotyping test, or liver biopsy

Key Exclusion Criteria:

  • Current or prior history of any clinically-significant illness (other than HCV)
  • Pregnant or nursing female or male with pregnant female partner
  • Chronic liver disease of a non-HCV etiology
  • Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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 China,   Hong Kong,   Korea, Republic of,   Taiwan,   Vietnam
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02021643
Other Study ID Numbers  ICMJE GS-US-334-0115
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gilead Sciences
Study Sponsor  ICMJE Gilead Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Gilead Study Director Gilead Sciences
PRS Account Gilead Sciences
Verification Date August 2017

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