Trials / Completed
CompletedNCT02356562
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
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 29 (actual)
- Sponsor
- AbbVie · Industry
- Sex
- All
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ombitasvir/paritaprevir/ritonavir and dasabuvir | tablet, ombitasvir coformulated with paritaprevir and ritonavir; tablet, dasabuvir |
| DRUG | Sofosbuvir | tablet |
| DRUG | Ribavirin | tablet |
Timeline
- Start date
- 2015-02-03
- Primary completion
- 2016-10-28
- Completion
- 2017-07-07
- First posted
- 2015-02-05
- Last updated
- 2017-12-20
- Results posted
- 2017-11-24
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02356562. Inclusion in this directory is not an endorsement.