A Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Ombitasvir/ABT-450/Ritonavir and Dasabuvir With or Without Sofosbuvir and RBV in DAA Treatment-experienced Adults With Chronic Hepatitis C Virus Infection

Status:	Completed
Conditions:	Infectious Disease, Hepatitis, Hepatitis, Hepatitis
Therapuetic Areas:	Immunology / Infectious Diseases
Healthy:	No
Age Range:	18 - 99
Updated:	10/22/2017
Start Date:	February 3, 2015
End Date:	July 7, 2017

An Open-Label Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Ombitasvir/ABT-450/Ritonavir (Ombitasvir/ABT-450/r) and Dasabuvir Co-administered With or Without Sofosbuvir (SOF) and Ribavirin (RBV) in Direct-Acting Antiviral Agent (DAA) Treatment-Experienced Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

The purpose of this study is to evaluate the safety and efficacy of ombitasvir/ABT-450/r and
dasabuvir with or without Sofosbuvir and RBV in DAA treatment-experienced adults with
Genotype 1 Chronic Hepatitis C Virus infection.

Inclusion Criteria:

- history of previous direct acting antiviral (DAA) therapy failure

- HCV genotype 1 infection

- Females must be post-menopausal, of non-child bearing potential or practicing specific
forms of birth control

Exclusion Criteria:

- Positive screen for hepatitis B surface antigen or anti-human immunodeficiency virus
antibody

- discontinuation of the prior DAA treatment for reasons other than virologic failure

- confirmed presence of hepatocellular carcinoma

- abnormal lab tests

We found this trial at

sites

Carolinas Center For Liver Disease /ID# 130297

633 Brookdale Drive
Statesville, North Carolina 28677

from

Statesville, NC