This trial is active, not recruiting.

Condition chronic hepatitis c infection
Treatments ombitasvir/abt-450/r, dasabuvir, sofosbuvir, ribavirin
Phase phase 2
Sponsor AbbVie
Start date February 2015
End date October 2016
Trial size 20 participants
Trial identifier NCT02356562, M14-224


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Ombitasvir/ABT-450/r once daily with dasabuvir twice daily with and without sofosbuvir (SOF) once daily for 12 or 24 weeks. HCV subtype 1 non-b subjects and all Harvoni failures will receive ribavirin (RBV) twice daily.
ombitasvir/abt-450/r Ombitasvir is also known as ABT-267, ABT-450 is also known as paritaprevir and r is also know as ritonavir
dasabuvir ABT-333
sofosbuvir Sovaldi

Primary Outcomes

Percentage of subjects with sustained virologic response 12 weeks post-treatment
time frame: 12 weeks after the last dose of active drug

Secondary Outcomes

Percentage of subjects with virologic failure during treatment
time frame: Up to week 24
Percentage of subjects with virologic relapse after treatment
time frame: 12 weeks after the last actual dose of active study drug
percentage of HCV Genotype 1a participants who are SOF/ledipasvir treatment experienced with sustained virologic response
time frame: 12 weeks after last dose of study drug

Eligibility Criteria

Male or female participants from 18 years up to 99 years old.

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

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by AbbVie.