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Ledipasvir/Sofosbuvir Fixed-Dose Combination and Vedroprevir With or Without Ribavirin in Treatment-Experienced Participants With Chronic Genotype 1 HCV Infection and Cirrhosis | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Ledipasvir/Sofosbuvir Fixed-Dose Combination and Vedroprevir With or Without Ribavirin in Treatment-Experienced Participants With Chronic Genotype 1 HCV Infection and Cirrhosis

A Phase 2, Randomized, Open-Label Study of Ledipasvir/Sofosbuvir Fixed-Dose Combination and Vedroprevir With or Without Ribavirin in Treatment-Experienced Subjects With Chronic Genotype 1 HCV Infection and Cirrhosis

NCT02226549•Gilead Sciences

View on ClinicalTrials.gov

Summary

This study is to evaluate the antiviral efficacy, safety, and tolerability of combination therapy with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) + vedroprevir (VDV) ± ribavirin (RBV) for 8 weeks in treatment-experienced adults with chronic genotype 1 hepatitis C virus (HCV) infection and cirrhosis.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age ≥ 18 years, with chronic HCV genotype 1 infection
•Documentation as treatment-experienced having received pegylated interferon (Peg-IFN) + RBV ≥ 4 weeks of duration without an additional agent in the regimen without achieving sustained viral response (SVR)
•Presence of compensated cirrhosis
•Screening laboratory values within defined thresholds
•Must use specific contraceptive methods if female of childbearing potential or sexually active male
•Not pregnant or a nursing female

Exclusion Criteria

•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

July 1, 2014

Primary Completion Date

February 1, 2015

Completion Date

February 1, 2015

Last Updated

November 16, 2018

Enrollment

ACTUAL participants

Conditions

Hepatitis C Virus Infection

Interventions

LDV/SOF

DRUG

VDV

DRUG

RBV

DRUG

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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 16, 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.

View ClinicalTrials.gov Terms and Conditions

Ledipasvir/Sofosbuvir Fixed-Dose Combination and Vedroprevir With or Without Ribavirin in Treatment-Experienced Participants With Chronic Genotype 1 HCV Infection and Cirrhosis

Inclusion Criteria

Exclusion Criteria

Acceptability of Simultaneous Screening for Viral Hepatitis B, C and HIV Among Drug Users in Non-conventional Structures

Relinking Diagnosed But Untreated HCV Patients Back Into Care.

Screening, Treatment, and Eradication of Hep C

Pharmacokinetics of Sofosbuvir/Daclatasvir in HCV-infected Lactating Women

HCV Reinfection After DAA Therapy in PWID in Belgium

Cross Sectional Survey on the Burden, Impacts and Causes of Hepatitis C Virus (HCV) Outbreak in South West Region in Burkina Faso