drugset / Trial / NCT01715415
A Study to Evaluate Chronic Hepatitis C Infection in Treatment Experienced Adults
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study is to evaluate the safety and efficacy of ABT-450, ritonavir and ABT-267 (ABT-450/r/ABT-267; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) co-administered with ribavirin (RBV) in hepatitis C virus genotype 1 infected treatment-experienced adults.
Timeline
- Start
- 2012-11
- Primary completion
- 2013-11
- Completion
- 2014-10
Outcome
Met primary endpoint
paper This rate was noninferior and superior to the historical control rate. PMID 24720679 ↗
Publications
- Results Zeuzem S, Jacobson IM, Baykal T, Marinho RT, Poordad F, Bourliere M, Sulkowski MS, Wedemeyer H, Tam E, Desmond P, Jensen DM, Di Bisceglie AM, Varunok P, Hassanein T, Xiong J, Pilot-Matias T, DaSilva-Tillmann B, Larsen L, Podsadecki T, Bernstein B. Retreatment of HCV with ABT-450/r-ombitasvir and dasabuvir with ribavirin. N Engl J Med. 2014 Apr 24;370(17):1604-14. doi: 10.1056/NEJMoa1401561. Epub 2014 Apr 10.
- Feld JJ, Bernstein DE, Younes Z, Vlierberghe HV, Larsen L, Tatsch F, Ferenci P. Ribavirin dose management in HCV patients receiving ombitasvir/paritaprevir/ritonavir and dasabuvir with ribavirin. Liver Int. 2018 Sep;38(9):1571-1575. doi: 10.1111/liv.13708. Epub 2018 Mar 14.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ritonavir | Other / unclassified | 100 mg | — |
| Subject | dasabuvir | Small molecule | 250 mg | — |
| Subject | ombitasvir | Small molecule | 25 mg | — |
| Subject | paritaprevir | Small molecule | 150 mg | — |
| Background | Ribavirin | Small molecule | 1000 mg | — |
| Background | Ribavirin | Small molecule | 1200 mg | — |