Trials / Terminated
TerminatedNCT02504099
A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/r With or Without Dasabuvir and With or Without Ribavirin in Chronic Hepatitis C Virus Genotype 1 or 4 Infected Adults With Successfully Treated Early Stage Hepatocellular Carcinoma
Open-label Study to Evaluate the Safety and Efficacy of the Combination of Ombitasvir, Paritaprevir/r ± Dasabuvir With or Without Ribavirin (RBV) in Adult Patients With GT1 or GT4 Chronic HCV Infection and Response to Prior Treatment of Early Stage Hepatocellular Carcinoma (GEODE - I)
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 3 (actual)
- Sponsor
- AbbVie · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety and efficacy of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r), with or without dasabuvir (DSV) coadministered with or without ribavirin (RBV) for 12 or 24 weeks in adult patients with genotype 1 or genotype 4 chronic HCV infection and treated early stage Hepatocellular Carcinoma with compensated cirrhosis.
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 |
| DRUG | ribavirin | Tablet |
Timeline
- Start date
- 2015-07-01
- Primary completion
- 2016-09-01
- Completion
- 2016-12-01
- First posted
- 2015-07-21
- Last updated
- 2017-12-12
- Results posted
- 2017-12-12
Source: ClinicalTrials.gov record NCT02504099. Inclusion in this directory is not an endorsement.