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

A Phase 2b, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination and Sofosbuvir + Ribavirin for Subjects With Chronic Hepatitis C Virus (HCV) and Inherited Bleeding Disorders

NCT02120300•Gilead Sciences

View on ClinicalTrials.gov

Summary

The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of treatment with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in participants with genotypes 1 and 4 hepatitis C virus (HCV) infection and sofosbuvir (SOF) plus ribavirin (RBV) in participants with genotypes 2 and 3 HCV infection. Participants with an inherited bleeding disorder and chronic HCV infection (either monoinfected or HIV-1/HCV coinfected) will be enrolled.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Hemophilia A, B or C, or Von Willebrand's disease
•Chronic genotype 1, 2, 3 or 4 HCV infection
•HCV RNA ≥ 1000 IU/mL at screening
•Use of protocol specified method(s) of contraception if female of childbearing potential or sexually active male
•Screening laboratory values within defined thresholds
•For HIV-1/HCV co-infected individuals:
•* Suppressed HIV-1 RNA on an antiretroviral (ARV) regimen for at least 6 months prior to screening
•* Stable protocol-approved ARV regimen for \> 8 weeks prior to screening
•* CD4 T-cell count \> 200 cells/mm\^3 at screening

Exclusion Criteria

•Clinically-significant illness (other than HCV, inherited bleeding disorder or HIV-1) or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
•Current or prior history of any of the following:
•* Hepatic decompensation
•* Chronic liver disease of a non-HCV etiology
•* Hepatocellular carcinoma (HCC)
•* Infection with hepatitis B virus (HBV)
•Pregnant or nursing female
•Prior treatment with inhibitors of nonstructural protein 5A (NS5A) or the NS5B polymerase
•Chronic use of systemically administered immunosuppressive agents
•For HIV-1/HCV co-infected individuals:
+2 more criteria

Locations (13)

Sacramento, California, United States

San Diego, California, United States

San Francisco, California, United States

Washington D.C., District of Columbia, United States

Atlanta, Georgia, United States

Boston, Massachusetts, United States

Minneapolis, Minnesota, United States

Newark, New Jersey, United States

New York, New York, United States

Key Dates

Start Date

April 1, 2014

Primary Completion Date

August 1, 2015

Completion Date

August 1, 2015

Last Updated

December 6, 2016

Enrollment

122

ACTUAL participants

Conditions

Chronic HCV Infection

Interventions

LDV/SOF

DRUG

SOF

DRUG

RBV

DRUG

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

NCT01984294

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: December 6, 2016Data 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.

View ClinicalTrials.gov Terms and Conditions