Trials / Completed
CompletedNCT03222583
A Study to Evaluate the Efficacy and Safety of Glecaprevir/Pibrentasvir (ABT-493/ABT-530) in Treatment-Naive and Treatment-Experienced, Non-Cirrhotic Asian Adults With Chronic Hepatitis C Virus Genotype (GT) 1 to GT6 Infection With or Without Human Immunodeficiency Virus Co-Infection
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Treatment-Naïve and Treatment-Experienced, Non-Cirrhotic Asian Adults With Chronic Hepatitis C Virus Genotype (GT) 1 to GT6 Infection With or Without Human Immunodeficiency Virus Co-Infection
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 546 (actual)
- Sponsor
- AbbVie · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the efficacy and safety of glecaprevir/pibrentasvir (ABT-493/ABT-530) in non-cirrhotic chronic hepatitis C virus (HCV) genotype (GT)1 to GT6-infected Asian participants with or without human immunodeficiency virus (HIV) co-infection who are HCV treatment-naïve or treatment-experienced with interferon (IFN) with or without ribavirin (RBV), OR sofosbuvir with RBV with or without IFN.
Detailed description
Randomization was stratified by geographic region (China, South Korea, Singapore), genotype (GT1, GT2, combined GT3 - 6), and HCV/HIV co-infection status (co-infected, not co-infected). In China, eligible participants were randomized to Arm A or Arm B (defined below) in the following ratios: 2:1 for GT1, 2:1 for GT2, and 2:1 for combined GT3-6. In South Korea and Singapore, eligible participants were randomized to Arm A or Arm B in the following ratios: 2:1 for GT1 and 2:1 for GT2. All Primary and Secondary Outcome Measures were pre-specified to be analyzed only in Arm A.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | Matching placebo tablet for oral administration |
| DRUG | Glecaprevir/Pibrentasvir | Coformulated tablet for oral administration |
Timeline
- Start date
- 2017-10-04
- Primary completion
- 2018-10-18
- Completion
- 2019-02-15
- First posted
- 2017-07-19
- Last updated
- 2019-12-23
- Results posted
- 2019-12-23
Locations
48 sites across 3 countries: China, Singapore, South Korea
Source: ClinicalTrials.gov record NCT03222583. Inclusion in this directory is not an endorsement.