Clinical Trial: Titrating-Dose of Lonafarnib in Combination With Ritonavir

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 2, Open-Label Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Activity of a Titrating-Dose Lonafarnib in Combination With Ritonavir in Patients Chronically Infected Wi

Brief Summary: A phase 2, open-label study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic activity of titrating-dose lonafarnib in combination with ritonavir in patients chronically infected with hepatitis delta virus

Detailed Summary:

This is a Phase 2 study of 24 weeks of treatment with a dose-titration regimen of lonafarnib/ritonavir in up to 15 patients chronically infected with HDV: lonafarnib starting at 50 mg bid in combination with ritonavir (100 mg bid) and escalating lonafarnib as tolerated.

The duration of the study for each patient is approximately 13 months (up to 4 weeks for screening, 24 weeks of treatment, 4 weeks for the primary follow-up visit, and monthly safety follow-up visits for 5 months thereafter). The 6-month follow-up after the last dose of study drug is designed to allow evaluation of the clinical and virologic course after completion of the 24-week Treatment Period.


Sponsor: Eiger BioPharmaceuticals

Current Primary Outcome: Number of Patients Tolerating Dose-Escalation from Lonafarnib 50 mg bid to 75 mg bid [ Time Frame: 6 months ]

Proportion of patients taking a lonafarnib dose greater than 50 mg bid at the end of the 24-week treatment period


Original Primary Outcome: Same as current

Current Secondary Outcome: Decrease in HDV viral load from baseline. [ Time Frame: 6 months ]

change in > 2 log in HDV viral load from baseline


Original Secondary Outcome: Same as current

Information By: Eiger BioPharmaceuticals

Dates:
Date Received: August 13, 2015
Date Started: September 2015
Date Completion:
Last Updated: September 14, 2016
Last Verified: September 2016