Completed

NCT Number: NCT02356562

A Study of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Sofosbuvir and Ribavirin in Direct-Acting Antiviral Agent Treatment-Experienced Adults With Chronic Hepatitis C Virus Infection

The purpose of this study is to evaluate the safety and efficacy of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without sofosbuvir (SOF) and ribavirin (RBV) in DAA treatment-experienced adults with Genotype 1 Chronic Hepatitis C Virus infection. This study will contain 2 parts.

Part 1: Approximately 20 participants and at least 10 of the 20 participants previously treated with the combination of ombitasvir/paritaprevir/ritonavir and dasabuvir, with or without RBV, and experienced treatment failure.

Part 2: Approximately 10 participants and all participants previously treated with SOF/ledipasvir and experienced treatment failure.

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Key information

Conditions

Chronic Hepatitis C Infection Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

Efficacy, safety, and demographic analyses were performed separately for the 2 study parts using the intent-to-treat (ITT) population, which consists of all enrolled participants who received at least one dose of study drug.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

History of previous direct acting antiviral (DAA) therapy failure; Part 2 only: history of previous direct acting antiviral (DAA) therapy failure and received at least 8 weeks of SOF/ledipasvir; participant must be treatment naïve to all other anti-HCV therapies
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

Treatment and study plan

ombitasvir/paritaprevir/ritonavir and dasabuvir

Drug

tablet, ombitasvir coformulated with paritaprevir and ritonavir; tablet, dasabuvir

Other names: ABT-450/r/ABT-267, Viekira Pak, paritaprevir also known as ABT-450, ombitasvir also known as ABT-267, dasabuvir also known as ABT-333

Sofosbuvir

Drug

tablet

Other names: Sovaldi

Ribavirin

Drug

tablet

Other names: RBV

Primary outcomes

Percentage of Part 1 Participants With Sustained Virologic Response 12 (SVR12) Weeks Posttreatment

Time frame: 12 weeks after the last dose of active drug

SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug.

Secondary outcomes

Percentage of Part 2 Participants With Sustained Virologic Response 12 (SVR12) Weeks Post-treatment

Time frame: 12 weeks after the last dose of active drug

SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug
Percentage of Participants With On-treatment Virologic Failure

Time frame: Up to week 24

On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after < LLOQ during treatment, confirmed increase of > 1 log (subscript)10(subscript) IU/mL above the lowest post-baseline HCV RNA during treatment, or HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks of treatment.
Percentage of Participants With Post-Treatment Relapse

Time frame: Within 12 weeks after the last actual dose of active study drug

Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after the last dose of study drug among participants completing treatment and with HCV RNA < LLOQ at the end of treatment.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study 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

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2017
First posted: Feb 5, 2015
Registry last updated: Dec 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed