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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)
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.
Details
| Lead sponsor | AbbVie |
|---|---|
| Phase | Phase 3 |
| Status | TERMINATED |
| Enrolment | 3 |
| Start date | 2015-07 |
| Completion | 2016-12 |
Conditions
- Chronic Hepatitis C Infection
Interventions
- ombitasvir/paritaprevir/ritonavir and dasabuvir
- ombitasvir/paritaprevir/ritonavir
- ribavirin
Primary outcomes
- Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) — 12 weeks after the last actual dose of study drug
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification \[\<LLOQ\]) 12 weeks after the last dose of study drug. Participants with missing data after flanking imputation were imputed as nonresponders.