Trials / Completed
CompletedNCT02207088
Ombitasvir/ABT-450/Ritonavir and Dasabuvir With or Without Ribavirin in HCV Genotype 1-Infected Adults With Chronic Kidney Disease
An Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection, With Severe Renal Impairment or End-Stage Renal Disease (RUBY-I)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 68 (actual)
- Sponsor
- AbbVie · Industry
- Sex
- All
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
Summary
This open-label study will evaluate safety, pharmacokinetics and efficacy of a 12 or 24-week regimen of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin in HCV-genotype 1-infected subjects with an Estimated Glomerular Filtration Rate (eGFR) \<30, including those on hemodialysis or peritoneal dialysis.
Conditions
- Chronic Hepatitis C
- Hepatitis C Virus
- Compensated Cirrhosis
- Severe Renal Impairment
- End-stage Renal Disease
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ombitasvir/paritaprevir/ritonavir | tablet |
| DRUG | dasabuvir | tablet |
| DRUG | Ribavirin | tablet |
Timeline
- Start date
- 2014-09-23
- Primary completion
- 2016-12-06
- Completion
- 2016-12-06
- First posted
- 2014-08-01
- Last updated
- 2017-11-09
- Results posted
- 2017-11-09
Source: ClinicalTrials.gov record NCT02207088. Inclusion in this directory is not an endorsement.