drugset / Trial / NCT02968641
A Study of Lonafarnib With or Without Ritonavir in Patients With HDV
RandomizedParallel-groupOpen-labelTreatment
Summary
A Phase 2b, Open-Label, Randomized Study of the Safety, Tolerability, and Pharmacodynamic Activity of Lonafarnib With or Without Ritonavir in Patients Chronically Infected with Hepatitis Delta Virus
Timeline
- Start
- —
- Primary completion
- 2021-02-12
- Completion
- —
Publications
- Background Koh C, Canini L, Dahari H, Zhao X, Uprichard SL, Haynes-Williams V, Winters MA, Subramanya G, Cooper SL, Pinto P, Wolff EF, Bishop R, Ai Thanda Han M, Cotler SJ, Kleiner DE, Keskin O, Idilman R, Yurdaydin C, Glenn JS, Heller T. Oral prenylation inhibition with lonafarnib in chronic hepatitis D infection: a proof-of-concept randomised, double-blind, placebo-controlled phase 2A trial. Lancet Infect Dis. 2015 Oct;15(10):1167-1174. doi: 10.1016/S1473-3099(15)00074-2. Epub 2015 Jul 16.
- Background Yurdaydin C, et al. Optimizing the Prenylation Inhibitor Lonafarnib Using Ritonavir Boosting in Patients with Chronic Delta Hepatitis. EASL 2015, Abstract 0118.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Lonafarnib | Small molecule | 25 mg | — |
| Comparator | Lonafarnib | Small molecule | 50 mg | — |
| Comparator | Lonafarnib | Small molecule | 100 mg | — |
| Comparator | Ritonavir | Other / unclassified | 100 mg | — |