Trials / Completed
CompletedNCT01314261
Study of ABT-267 in Treatment Naive Hepatitis C Virus (HCV) Genotype 1 Infected Subjects
A Blinded, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Pharmacokinetics, and Antiviral Activity of ABT-267 in Combination With Peginterferon Alpha-2a and Ribavirin (pegIFN/RBV) in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 37 (actual)
- Sponsor
- AbbVie (prior sponsor, Abbott) · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study was to assess the safety, pharmacokinetics, and 4-week rapid virologic response (RVR) of 3 different doses of ABT-267 (also known as ombitasvir) in combination with pegylated interferon/ribavirin (pegIFN/RBV) compared with pegIFN/RBV alone (ABT-267 placebo) in treatment naïve, hepatitis C virus (HCV), genotype 1-infected participants.
Detailed description
The study was a randomized, double blind, placebo controlled study consisting of 2 substudies. In substudy 1, participants received 1 of 3 doses of ABT-267 or placebo + pegIFN/RBV for 12 weeks. In substudy 2, participants received pegIFN/RBV for 36 weeks. Participants were followed for 48 weeks post ABT-267 treatment for evaluation of efficacy and safety.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ABT-267 | 5 mg or 25 mg tablets |
| DRUG | Pegylated interferon (pegIFN) | Syringe, 180 µg/0.5 mL for subcutaneous injections administered weekly |
| DRUG | Ribavirin (RBV) | 200 mg tablet dosed at 1000 or 1200 mg daily divided twice a day |
| OTHER | Placebo for ABT-267 | Participants received matching placebo tablet at each dose level for ABT-267. |
Timeline
- Start date
- 2011-03-01
- Primary completion
- 2012-01-01
- Completion
- 2013-02-01
- First posted
- 2011-03-14
- Last updated
- 2018-07-02
- Results posted
- 2015-01-26
Locations
11 sites across 2 countries: United States, Puerto Rico
Source: ClinicalTrials.gov record NCT01314261. Inclusion in this directory is not an endorsement.