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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: August 20, 2014
Last verified: August 2014
  Purpose

This study will evaluate the efficacy, safety, and tolerability 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).


Condition Intervention Phase
Chronic Hepatitis C
Drug: Sofosbuvir
Drug: RBV
Drug: PEG
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Proportion of participants with sustained virologic response 12 weeks after discontinuation of therapy (SVR12) [ Time Frame: Posttreatment 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 drug.

  • Any adverse event (AE) leading to permanent discontinuation of study drug [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of participants with sustained virologic response 4 and 24 weeks after discontinuation of treatment (SVR4 and SVR 24) [ Time Frame: Posttreatment Weeks 4 and 24 ] [ Designated as safety issue: No ]
    SVR4 and SVR24 is defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.

  • Proportion of participants with on-treatment virologic failure [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]

    On-treatment virologic failure is defined as:

    • HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ, while on treatment,
    • > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment,
    • HCV RNA persistently ≥ LLOQ through 8 weeks of treatment (ie, nonresponse)

  • Proportion of participants with virologic relapse [ Time Frame: Up to Posttreatment Week 24 ] [ Designated as safety issue: No ]
    Viral relapse is 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.


Enrollment: 533
Study Start Date: June 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sofosbuvir+RBV 12 weeks
Participants will receive sofosbuvir+RBV for 12 weeks.
Drug: Sofosbuvir
Sofosbuvir 400 mg tablet administered orally once daily
Other Names:
  • GS-7977
  • PSI-7977
  • Sovaldi®
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)
Experimental: Sofosbuvir+RBV 24 weeks
Participants will receive sofosbuvir+RBV for 24 weeks.
Drug: Sofosbuvir
Sofosbuvir 400 mg tablet administered orally once daily
Other Names:
  • GS-7977
  • PSI-7977
  • Sovaldi®
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)
Experimental: Sofosbuvir+RBV+PEG 12 weeks
Participants will receive sofosbuvir+RBV+PEG for 12 weeks.
Drug: Sofosbuvir
Sofosbuvir 400 mg tablet administered orally once daily
Other Names:
  • GS-7977
  • PSI-7977
  • Sovaldi®
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01625338

  Show 175 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Bittoo Kanwar, MD Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01625338     History of Changes
Other Study ID Numbers: GS-US-334-0109, 2012-000571-16
Study First Received: June 7, 2012
Last Updated: August 20, 2014
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Austria: Federal Office for Safety in Health Care
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Sweden: Medical Products Agency
Italy: Ethics Committee
France: Agence Nationale de Sécurité du Médicament et des produits de santé
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Estonia: The State Agency of Medicine
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Gilead Sciences:
HCV genotype 2 (GT-2)
HCV genotype 3 (GT-3)
HCV
Sustained Virologic Response
Direct Acting Antiviral
Combination Therapy
GS-7977
Ribavirin
Open Label

Additional relevant MeSH terms:
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Digestive System Diseases
Flaviviridae Infections
Hepatitis
Hepatitis, Viral, Human
Liver Diseases
RNA Virus Infections
Virus Diseases
Interferon-alpha
Peginterferon alfa-2a
Ribavirin
Anti-Infective Agents
Antimetabolites
Antiviral Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014