Titrating-Dose of Lonafarnib in Combination With Ritonavir — LOWR-4  

Chronic Delta Hepatitis Clinical Trial

Official title: A Phase 2, Open-Label Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Activity of a Titrating-Dose Lonafarnib/Ritonavir in Patients Chronically Infected With Hepatitis Delta Virus

Status Completed

Clinical Trial Summary

A phase 2, open-label study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic activity of titrating-dose lonafarnib/ritonavir in patients chronically infected with hepatitis delta virus (HDV)

Clinical Trial Description

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 twice daily (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. ;

Related Conditions & MeSH terms

• Chronic Delta Hepatitis
• Hepatitis
• Hepatitis D
• Hepatitis D, Chronic

• NCT number: NCT02527707
• Study type: Interventional
• Source: Eiger BioPharmaceuticals
• Status: Completed
• Phase: Phase 2
• Start date: September 2015
• Completion date: February 9, 2017