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Safety and Efficacy of LDV/SOF Fixed-Dose Combination (FDC) ± Ribavirin in HCV Genotype 1 Subjects | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Safety and Efficacy of LDV/SOF Fixed-Dose Combination (FDC) ± Ribavirin in HCV Genotype 1 Subjects

A Phase 2, Randomized, Open-Label Study of Sofosbuvir/GS-5885 Fixed-Dose Combination ± Ribavirin in Subjects With Chronic Genotype 1 HCV Infection

NCT01726517•Gilead Sciences

View on ClinicalTrials.gov

Summary

This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV), administered for 8 or 12 weeks of treatment in participants with chronic genotype 1 hepatitis C virus (HCV) infection who are treatment-naive, and for 12 weeks in participants who had previously received a regimen containing a protease inhibitor for the treatment of HCV.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age ≥ 18 years, with chronic genotype 1 HCV infection
•HCV RNA equal to or greater than 10,000 IU/mL at screening
•Cirrhosis determination; a liver biopsy may be required
•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
•Current or prior history of clinical hepatic decompensation
•Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
•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, 2012

Primary Completion Date

July 1, 2013

Completion Date

January 1, 2014

Last Updated

November 16, 2018

Enrollment

100

ACTUAL participants

Conditions

Chronic Hepatitis C Virus

Interventions

LDV/SOF

DRUG

RBV

DRUG

A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

NCT02219490

Chronic Hepatitis C Virus (HCV) Infection Genotype 1

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COMPLETEDPHASE3

A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

NCT02167945

Chronic Hepatitis C Virus (HCV) Infection Genotype 1

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 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 LDV/SOF Fixed-Dose Combination (FDC) ± Ribavirin in HCV Genotype 1 Subjects

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Japanese Adults With Chronic Hepatitis C Virus Infection

Sofosbuvir/Ombitasvir/Paritaprevir/ Ritonavir and Ribavirin for Hepatitis C Virus Genotype 4 Patients

Sofosbuvir With Ribavirin or Simeprevir With HCV GT4 Egyptian Patients

Drug Use-results Survey in Patients Infected With Hepatitis C Virus Genotype 1