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Sofosbuvir Plus Ribavirin Administered for Either 12 or 24 Weeks in Treatment-Naïve and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 Hepatitis C Virus (HCV) Infection

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01713283
First received: October 17, 2012
Last updated: March 20, 2013
Last verified: March 2013
History of Changes
  Purpose

This is a research study to evaluate the safety, tolerability, and anti-viral activity of sofosbuvir with ribavirin in Egyptian adults with genotype 4 hepatitis C infection.


Condition Intervention Phase
Hepatitis C Virus
 Drug: Sofosbuvir
Drug: Ribavirin (RBV)
 Phase 2

Access to an investigational treatment associated with this study is available outside the clinical trial.   More info ...

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

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 post dosing [ Time Frame: up to 36 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 sofosbuvir+ ribavirin when given for 12 or 24 weeks [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
    The safety and tolerability of sofosbuvir+ ribavirin as assessed by review of the accumulated safety data


Secondary Outcome Measures:
  • HCV RNA [ Time Frame: up to 48 weeks ] [ Designated as safety issue: No ]
    The kinetics of circulating HCV RNA during treatment and after treatment discontinuation

  • Efficacy 4 and 24 weeks post-dosing [ Time Frame: up to 48 weeks ] [ Designated as safety issue: No ]
    The proportion of subjects who attain SVR at 4 and 24 weeks after discontinuation of therapy (SVR4 and SVR24)

  • Resistance [ Time Frame: up to 48 weeks ] [ Designated as safety issue: No ]
    The emergence of viral resistance to sofosbuvir during treatment and after treatment discontinuation


Estimated Enrollment: 60
Study Start Date: October 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sofosbuvir 400 mg + RBV 12 weeks
Arm 1 ( N= 30) Sofosbuvir 400 mg + RBV (1000-1200 mg/day) for 12 weeks by mouth daily
 Drug: Sofosbuvir
Sofosbuvir 400 mg by mouth daily
Drug: Ribavirin (RBV)
RBV (1000 or 1200 mg/day) by mouth daily
Experimental: Sofosbuvir 400 mg + RBV 24 weeks
Arm 2 ( N=30) Sofosbuvir 400 mg + RBV (1000-1200 mg/day) for 24 weeks by mouth daily
 Drug: Sofosbuvir
Sofosbuvir 400 mg by mouth daily
Drug: Ribavirin (RBV)
RBV (1000 or 1200 mg/day) by mouth daily

  Eligibility

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

Inclusion Criteria:

  • First generation Egyptian. Subjects must have been born in Egypt and can trace both maternal and paternal Egyptian ancestry.
  • Treatment experienced and naïve subjects
  • Chronic genotype 4 HCV-infection
  • Not co-infected with HIV
  • Screening laboratory values within defined thresholds
  • Use of highly effective contraception methods
  • Subject must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments.

Exclusion Criteria:

  • History of any other clinically significant chronic liver disease
  • Pregnant or nursing female or male with pregnant female partner
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01713283

Locations
United States, California
Los Angeles, California, United States
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Kathryn Kersey Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01713283     History of Changes
Other Study ID Numbers: GS-US-334-0114
Study First Received: October 17, 2012
Last Updated: March 20, 2013
Health Authority: United States: Food and Drug Administration

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 June 17, 2013