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GS-7977 and Ribavirin in Treatment Naive and Treatment Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01682720
First received: September 5, 2012
Last updated: March 1, 2013
Last verified: March 2013
History of Changes
  Purpose

The purpose of this study is to determine if GS-7977 and Ribavirin is effective and safe in the treatment of Genotype 2 or 3 HCV infection.


Condition Intervention Phase
Hepatitis C
 Drug: GS-7977 + RBV
Drug: GS-7977 placebo + RBV placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GS-7977+Ribavirin for 12 Weeks in Treatment Naive and Treatment Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection.

Resource links provided by NLM:

Drug Information available for: Ribavirin
U.S. FDA Resources

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Efficacy 12 weeks after discontinuation of therapy. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    •To determine the efficacy of treatment with GS 7977+ ribavirin (RBV) as measured by the proportion of subjects with sustained viral response 12 weeks after discontinuation of therapy (SVR12)

  • Safety and tolerability of GS-7977 + RBV. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    •To assess the safety and tolerability of GS-7977+RBV as measured by review of the accumulated safety data.


Secondary Outcome Measures:
  • Efficacy 4 and 24 weeks after discontinuation of therapy. [ Time Frame: 16 weeks and 36 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).

  • Efficacy of treatment with GS-7977 + RBV based on prior treatment history. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    To determine the efficacy of treatment with GS-7977 + RBV based on prior treatment history.

  • Kinetics of circulating HCV RNA during and after treatment discontinuation. [ Time Frame: 12 weeks and 36 weeks ] [ Designated as safety issue: No ]
    To evaluate the kinetics of circulating HCV RNA during treatment and after treatment discontinuation.

  • Viral resistance to GS-7977 during and after treatment discontinuation. [ Time Frame: 12 weeks and 36 weeks ] [ Designated as safety issue: No ]
    To evaluate the emergence of viral resistance to GS-7977 during treatment and after treatment discontinuation.


Estimated Enrollment: 400
Study Start Date: September 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GS-7977
Approximately 320 subjects will be randomized to Arm 1.
 Drug: GS-7977 + RBV
GS-7977 400 mg QD + RBV (1000 or 1200 mg.day) BID for 12 weeks.
Other Names:
  • -Sofosbuvir
  • -PSI-7977
  • -GS-7977
  • -Ribavirin
  • -RBV
Placebo Comparator: Placebo
Approximately 80 subjects will be randomized to Arm 2.
 Drug: GS-7977 placebo + RBV placebo
GS-7977 placebo QD + RBV placebo BID
Other Names:
  • -Sofosbuvir
  • -PSI-7977
  • -GS-7977
  • -Ribavirin
  • -RBV

  Eligibility

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

Inclusion Criteria:

  • Age > 18 with chronic genotype 2 or 3 HCV infection.
  • HCV RNA > 10,000 IU/mL at Screening.
  • Subjects must be treatment naïve or treatment experienced.
  • Presence or absence of cirrhosis; a liver biopsy may be required.
  • Healthy according to medical history and physical examination with the exception of HCV diagnosis.
  • Agree to use two forms of highly effective contraception for the duration of the study and 6 months after the last dose of study medication.

Exclusion Criteria:

  • Prior use of any other inhibitor of the HCV NS5B Polymerase.
  • History of any other clinically significant chronic liver disease.
  • Evidence of or history of decompensated liver disease.
  • HIV or chronic hepatitis B virus (HBV) infection.
  • Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers).
  • Chronic use of immunosuppressive agents or immunomodulatory agents.
  • History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study or not be in the best interest of the subject in the opinion of the investigator.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01682720

  Show 78 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Rob Hyland, DPhil Gilead Sciences Study Director
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01682720     History of Changes
Other Study ID Numbers: GS-US-334-0133, 2012-001942-16
Study First Received: September 5, 2012
Last Updated: March 1, 2013
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: L’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
Genotype 3

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
 RNA Virus Infections
Flaviviridae Infections
Ribavirin
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013