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COMPLETEDPHASE2

Efficacy and Safety of Oral Regimens for the Treatment of Chronic HCV Infection

A Phase 2, Multicenter, Open-Label Study to Assess the Efficacy and Safety of Oral Regimens for the Treatment of Chronic HCV Infection

NCT02202980•Gilead Sciences

View on ClinicalTrials.gov

Summary

This study will evaluate the antiviral efficacy, safety, and tolerability of combination therapy with oral regimens for the treatment of chronic hepatitis C virus (HCV) infection.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Willing and able to provide written informed consent
•Chronic HCV infection
•Cirrhosis determination (liver biopsy may be required)
•Screening laboratory values within specified limits
•Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
•Specific genotype, prior medical history, or concurrent disease as required by the specific study group

Exclusion Criteria

•History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
•Pregnant or nursing female, or male with pregnant female partner
•Clinical hepatic decompensation (ie, ascites, encephalopathy or variceal hemorrhage)
•Use of any prohibited concomitant medications

Locations (2)

Auckland, New Zealand

Christchurch, New Zealand

Key Dates

Start Date

August 4, 2014

Primary Completion Date

March 16, 2016

Completion Date

May 9, 2016

Last Updated

November 16, 2018

Enrollment

273

ACTUAL participants

Conditions

Chronic Hepatitis C

Interventions

LDV/SOF

DRUG

RBV

DRUG

SOF/VEL

DRUG

VOX

DRUG

Study of the Pharmacokinetic Action of Amantadine and Ribavirin in Chronic Hepatitis C. CINAM

NCT00199719

Chronic Hepatitis C

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COMPLETEDPHASE4

Study of the Efficacy and Safety of Pegnano Plus Barivir (Ribavirin) in Treatment-naïve Patients With Chronic Hepatitis C at KienGiang General Hospital

NCT06922643

Chronic Hepatitis C

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COMPLETEDNA

Changes in Liver Fibrosis, Lipid Profile and Insulin Resistance in HCV Patients Who Received Antiviral Therapy

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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Efficacy and Safety of Oral Regimens for the Treatment of Chronic HCV Infection

Inclusion Criteria

Exclusion Criteria

Study of the Pharmacokinetic Action of Amantadine and Ribavirin in Chronic Hepatitis C. CINAM

Study of the Efficacy and Safety of Pegnano Plus Barivir (Ribavirin) in Treatment-naïve Patients With Chronic Hepatitis C at KienGiang General Hospital

Changes in Liver Fibrosis, Lipid Profile and Insulin Resistance in HCV Patients Who Received Antiviral Therapy

Efficacy and Safety Study of Pegylated Interferon Lambda-1a With Ribavirin and Daclatasvir, to Treat naïve Subjects With Chronic HCV Genotypes 1, 2, 3, and 4 Who Are Co-infected With HIV

Treatment of HCV-Infected Recent Injection Drug Users in U.S. Liver Clinics

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