Trials / Completed
CompletedNCT02023099
Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) in Japanese Adults With Subgenotype 1b Chronic Hepatitis C Virus (HCV) Infection
A Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) in Treatment-Naïve and Treatment-Experienced Japanese Adults With Subgenotype 1b Chronic Hepatitis C Virus (HCV) Infection With and Without Compensated Cirrhosis (GIFT I)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 363 (actual)
- Sponsor
- AbbVie · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This is a phase 3, double-blinded, multicenter study. The study will consist of 2 substudies: Substudy 1 (SS1) will be double-blinded and enroll non-cirrhotic subjects and Substudy 2 (SS2) will be open label and enroll subjects with compensated cirrhosis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ABT-450/r/ABT-267 | Tablet; ABT-450 coformulated with ritonavir and ABT-267 |
| DRUG | Placebo | Tablet |
Timeline
- Start date
- 2013-12-01
- Primary completion
- 2014-10-01
- Completion
- 2015-10-01
- First posted
- 2013-12-30
- Last updated
- 2018-06-06
- Results posted
- 2015-11-26
Source: ClinicalTrials.gov record NCT02023099. Inclusion in this directory is not an endorsement.