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Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination Tablet With Ribavirin for 12 Weeks in Treatment-naive Adults With Chronic HCV Genotype 3 Infection | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination Tablet With Ribavirin for 12 Weeks in Treatment-naive Adults With Chronic HCV Genotype 3 Infection

A Phase 2 Open- Label Study to Evaluate The Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination Tablet With Ribavirin for 12 Weeks in Treatment-naïve Patients With Chronic HCV Genotype 3 Infection

NCT02413593•Gilead Sciences

View on ClinicalTrials.gov

Summary

This study will evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) plus ribavirin (RBV) in treatment-naive adults with chronic genotype 3 hepatitis C virus (HCV) infection.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Chronic genotype 3 HCV infection
•HCV treatment-naive
•HCV RNA \> 10,000 IU/mL at screening
•Absence of cirrhosis or 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
•Coinfection 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 the individual's treatment, assessment, or compliance with the protocol

Locations (15)

Calgary, Alberta, Canada

Edmonton, Alberta, Canada

Vancouver, British Columbia, Canada

Brampton, Ontario, Canada

London, Ontario, Canada

Ottawa, Ontario, Canada

Toronto, Ontario, Canada

Key Dates

Start Date

April 1, 2015

Primary Completion Date

December 1, 2015

Completion Date

January 1, 2016

Last Updated

November 16, 2018

Enrollment

111

ACTUAL participants

Conditions

Hepatitis C Virus Infection

Interventions

LDV/SOF

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.

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Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination Tablet With Ribavirin for 12 Weeks in Treatment-naive Adults With Chronic HCV Genotype 3 Infection

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

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