Once Daily Dosing of Lonafarnib Co-administered With Ritonavir for Treatment of Chronic Hepatitis D Virus Infection

Summary

Open label, single arm, multi-center clinical trial of lonafarnib 50 mg QD plus ritonavir 200 mg QD, administered orally, over a 48-week treatment period, with a 24-week post-treatment follow-up period, in patients with chronic Hepatitis D Virusinfection. Objectives: To evaluate the safety and tolerability of once daily dosing of lonafarnib 50 mg with ritonavir 200 mg over a 48-week treatment period. To evaluate the effect of once daily dosing of lonafarnib 50 mg with ritonavir 200 mg over a 48-week treatment period with a 24-week post-treatment follow-up on HDV viral levels. Trial population: Up to 30 patients with chronic HDV infection with detectable HDV RNA and compensated liver disease.

Timeline

Start

2021-05-15

Primary completion

2025-02-05

Completion

2025-02-05

Drugs

Indications