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A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin in US Veterans With Genotype 1 Chronic Hepatitis C Virus Infection | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin in US Veterans With Genotype 1 Chronic Hepatitis C Virus Infection

An Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin (RBV) in US Veterans With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (TOPAZ-VA)

NCT02442284•AbbVie

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the safety and efficacy of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin in US veterans with genotype 1 chronic hepatitis C virus infection.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•US military veteran currently receiving healthcare through the Veterans Health Administration
•Screening laboratory result indicating hepatitis C virus (HCV), genotype 1-infection
•Positive for hepatitis C antibodies or HCV RNA at least 6 months before Screening, and HCV RNA \> 1,000 IU/mL at the time of Screening or HCV RNA \> 1,000 IU/mL at the time of Screening with a liver biopsy consistent with chronic HCV-infection (or a liver biopsy performed prior to enrollment with evidence of chronic hepatitis C disease)

Exclusion Criteria

•Women who are pregnant or breastfeeding
•Positive test result for hepatitis B surface antigen (HbsAg) or anti-HIV antibodies (HIV Ab)
•Prior or current use of any investigational or commercially available anti-HCV agents other than IFN, pegIFN, RBV or sofosbuvir
•Any current or past clinical evidence of Child-Pugh B or C classification
•Confirmed presence of hepatocellular carcinoma indicated on imaging techniques within 3 months prior to Screening or on an ultrasound performed at Screening for participants with cirrhosis

Key Dates

Start Date

May 13, 2015

Primary Completion Date

August 22, 2016

Completion Date

October 31, 2016

Last Updated

October 16, 2017

Enrollment

ACTUAL participants

Conditions

Chronic Hepatitis CCirrhosisHepatitis C Virus

Interventions

ombitasvir/paritaprevir/ritonavir and dasabuvir

DRUG

Ribavirin

DRUG

EUS Guided Portal-systemic Pressure Gradient Measurement to Predict Treatment Response and Outcomes of Varices to Endoscopic Variceal Ligation in Patients With Chronic Hepatitis.

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Cirrhosis Portal

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RECRUITINGNA

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RECRUITING

Prevalence of Gastric Motor Dysfunction and Upper GI Symptoms in Gastric Antral Vascular Ectasias

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: October 16, 2017Data 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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A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin in US Veterans With Genotype 1 Chronic Hepatitis C Virus Infection

Inclusion Criteria

Exclusion Criteria

EUS Guided Portal-systemic Pressure Gradient Measurement to Predict Treatment Response and Outcomes of Varices to Endoscopic Variceal Ligation in Patients With Chronic Hepatitis.

Remote Electrical Stimulation for Pain and Depression Treatment in Cirrhosis

Prevalence of Gastric Motor Dysfunction and Upper GI Symptoms in Gastric Antral Vascular Ectasias

Mechanism of TIPS to Improve Sarcopenia

Diagnosis of Lymphohistiocytic Hemophagocytosis in Intensive Care

Verification of Risk Factors of Thrombohemorrhagic Complications in Recipients After Related Liver Transplantation