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Safety and Efficacy of Ledipasvir/Sofosbuvir in Adults With Chronic HCV Infection | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Safety and Efficacy of Ledipasvir/Sofosbuvir in Adults With Chronic HCV Infection

A Phase 3b, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of Ledipasvir/Sofosbuvir in Adults With Chronic HCV Infection

NCT02472886•Gilead Sciences

View on ClinicalTrials.gov

Summary

The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) with or without ribavirin (RBV) in adults with chronic hepatitis C virus (HCV) infection.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Exclusion Criteria

•Chronic genotype 1 HCV infection
•HCV treatment-naive
•HCV RNA \> 10,000 IU/mL at screening
•Absence of cirrhosis
•Screening laboratory values within defined thresholds
•Use of two effective contraception methods if female of childbearing potential or sexually active male
•Pregnant or nursing female or male with pregnant female partner
•Infection with hepatitis B virus (HBV)
•Current or prior history of clinical hepatic decompensation
•Chronic use of systemic immunosuppressive agents
+5 more criteria

Locations (20)

Tallinn, Estonia

Tartu, Estonia

Krasnoyarsk, Russia

Moscow, Russia

Key Dates

Start Date

June 17, 2015

Primary Completion Date

March 30, 2016

Completion Date

June 30, 2016

Last Updated

November 16, 2018

Enrollment

153

ACTUAL participants

Conditions

Hepatitis C Virus Infection

Interventions

LDV/SOF

DRUG

RBV

DRUG

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COMPLETED

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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 in Adults With Chronic HCV Infection

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

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