Completed

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.

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Placebo to match SOF

+ Placebo to match RBV

+ SOF

Drug
Who is being recruted

Blood-Borne Infections+8

+ Communicable Diseases

+ Digestive System Diseases

Over 18 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: September 2012
See protocol details

Summary

Principal SponsorGilead Sciences
Last updated: October 9, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2012

Actual date on which the first participant was enrolled.

This study will evaluate the safety, tolerability, and antiviral efficacy of GS-7977 with ribavirin (RBV) in participants with genotype 2 or 3 hepatitis C virus (HCV) infection.

NCT01682720
Principal SponsorGilead Sciences
Last updated: October 9, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

421 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsCommunicable DiseasesDigestive System DiseasesHepatitisHepatitis, Viral, HumanInfectionsLiver DiseasesRNA Virus InfectionsVirus DiseasesFlaviviridae InfectionsHepatitis C

Criteria

6 inclusion criteria required to participate
Age > 18 with chronic genotype 2 or 3 HCV infection
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
HCV RNA > 10,000 IU/mL at screening
Healthy according to medical history and physical examination with the exception of HCV diagnosis
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7 exclusion criteria prevent from participating
Chronic use of immunosuppressive agents or immunomodulatory agents
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)
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Placebo
Placebo to match SOF + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection.

Group II

Experimental
Placebo to match SOF + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection.

Group III

Experimental
SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 77 locations

Medizinische Universitat Graz

Graz, AustriaOpen Medizinische Universitat Graz in Google Maps

Medizinische Universitat Wien

Vienna, Austria

Wilhelminenspital

Vienna, Austria

West Tallinn Central Hospital

Tallinn, Estonia
Completed77 Study Centers