Trials / Withdrawn
WithdrawnNCT02806362
Study of Ombitasvir/Paritaprevir/Ritonavir in Japanese Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection With End Stage Renal Disease (ESRD) on Hemodialysis (HD)
An Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir in Japanese Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection With End Stage Renal Disease on Hemodialysis (GIFT-R)
- Status
- Withdrawn
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- AbbVie · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this multicenter, single-arm, combination-drug study, which includes 12 weeks of treatment and 24 weeks of follow-up, is to evaluate the safety, efficacy and pharmacokinetics of ombitasvir/paritaprevir/ritonavir in Japanese adults infected with HCV GT1b, who are treatment-naïve or treatment-experienced to an IFN-based regimen and who have ESRD on HD.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ombitasvir/paritaprevir/ritonavir | Tablet |
Timeline
- Start date
- 2016-09-01
- Primary completion
- 2018-06-01
- Completion
- 2018-08-01
- First posted
- 2016-06-20
- Last updated
- 2016-12-05
Source: ClinicalTrials.gov record NCT02806362. Inclusion in this directory is not an endorsement.