Trials / Completed
CompletedNCT02487199
Ombitasvir/Paritaprevir/Ritonavir With or Without Dasabuvir in Adults With Genotype 1a or Genotype 4 Chronic Hepatitis C Virus (HCV) Infection, With Severe Kidney Impairment or End Stage Kidney Disease
An Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir With or Without Dasabuvir in Adults With Genotype 1a or Genotype 4 Chronic Hepatitis C Virus (HCV) Infection, With Severe Renal Impairment or End-Stage Renal Disease (RUBY-II)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- AbbVie · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study evaluates the efficacy and safety of ombitasvir/paritaprevir/ritonavir with or without dasabuvir in adults with hepatitis C virus (HCV) genotype 1a (GT1a) or genotype 4 (GT4) infection and with severe kidney impairment or end-stage kidney disease.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ombitasvir/paritaprevir/ritonavir and dasabuvir | Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet |
| DRUG | ombitasvir/paritaprevir/ritonavir | Tablet; ombitasvir coformulated with paritaprevir and ritonavir |
Timeline
- Start date
- 2015-09-30
- Primary completion
- 2016-12-05
- Completion
- 2016-12-05
- First posted
- 2015-07-01
- Last updated
- 2017-12-04
- Results posted
- 2017-12-04
Source: ClinicalTrials.gov record NCT02487199. Inclusion in this directory is not an endorsement.