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Ledipasvir/Sofosbuvir Fixed-Dose Combination With Ribavirin or GS-9669 in Subjects With Chronic Genotype 1 HCV Infection | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Ledipasvir/Sofosbuvir Fixed-Dose Combination With Ribavirin or GS-9669 in Subjects With Chronic Genotype 1 HCV Infection

A Phase 2, Randomized, Open-Label Study of Sofosbuvir/Ledipasvir Fixed-Dose Combination With Ribavirin or GS-9669 250 mg or GS-9669 500 mg in Naive or Treatment-Experienced Cirrhotic Subjects With Chronic Genotype 1 HCV Infection

NCT01984294•Gilead Sciences

View on ClinicalTrials.gov

Summary

This study will evaluate the antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) plus ribavirin (RBV) or LDV/SOF plus GS-9669 in treatment-naive or treatment-experienced participants with chronic genotype 1 hepatitis C virus (HCV) infection. A total of 90 participants are planned to be enrolled in the study for 8 weeks of treatment, approximately 60 having had prior treatment with a regimen containing pegylated interferon (PEG) and RBV for ≥ 12 weeks. Randomization will be stratified by treatment-naive versus treatment-experienced and by HCV genotype (1a versus 1b).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age ≥ 18, with chronic genotype 1 HCV infection
•Documented HCV treatment-naïve or treatment-experienced subjects who failed previous PEG+RBV regimen
•HCV RNA \> 10,000 IU/mL at Screening
•Presence of compensated cirrhosis
•Screening laboratory values within defined thresholds
•Use of two effective contraception methods if female of childbearing potential or sexually active male

Exclusion Criteria

•Pregnant or nursing female or male with pregnant female partner
•Co-infection with HIV or hepatitis B virus (HBV)
•Current or prior history of clinical hepatic decompensation
•Chronic use of systemic immunosuppressive agents
•History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol

Locations (1)

San Antonio, Texas, United States

Key Dates

Start Date

October 1, 2013

Primary Completion Date

April 1, 2014

Completion Date

July 1, 2014

Last Updated

November 19, 2018

Enrollment

101

ACTUAL participants

Conditions

Chronic HCV Infection

Interventions

LDV/SOF

DRUG

RBV

DRUG

GS-9669

DRUG

Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination and Sofosbuvir + Ribavirin for Subjects With Chronic Hepatitis C Virus (HCV) and Inherited Bleeding Disorders

NCT02120300

Chronic HCV Infection

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 19, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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