NCT02430181

Lonafarnib With and Without Ritonavir in HDV (LOWR-1)

An Open-label, Dose-ranging, Proof-of-Concept Study to Evaluate the Safety and Efficacy of Lonafarnib With and Without Ritonavir Boosting in Patients Chronically Infected With Delta Hepatitis (HDV) (LOWR-1)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Eiger BioPharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To Evaluate the Safety and Efficacy of Lonafarnib with and without Ritonavir Boosting in Adults With Genotype 1 Chronic Hepatitis D Virus (HDV) Infection (LOWR-1).

Detailed description

Chronic delta hepatitis is a serious form of chronic liver disease caused by infection with the hepatitis D virus (HDV), a small RNA virus that requires farnesylation of its major structural protein (HDV antigen) for replication. Twenty-one subjects with chronic delta hepatitis will be randomized to receive one of seven different doses of lonafarnib. Dosing will occur over 4-12 weeks, depending on treatment arm, and during that time, evidence of antiviral response will be assessed by frequent measurements of HDV-RNA. The primary therapeutic endpoint will be an improvement in quantitative serum HDV RNA levels after treatment with lonafarnib therapy. The primary safety endpoint will be the ability to tolerate the drug at the prescribed dose for the treatment duration. Several secondary endpoints will be measured, including side effects, ALT levels, and symptoms. Therapy will be stopped for intolerance to lonafarnib. This study is designed as a phase 2a study assessing the safety, tolerance and antiviral activity of seven dose combinations of lonafarnib with and without ritonavir boosting.

Conditions

• Chronic Hepatitis D Infection

Interventions

Type	Name	Description
DRUG	lonafarnib	antiviral farnesyl transferase inhibitor
DRUG	peginterferon alfa-2a	immunomodulator
DRUG	ritonavir	CYP 3A4 inhibitor, lonafarnib booster

Timeline

• Start date: 2014-11-01
• Primary completion: 2015-09-01
• Completion: 2015-11-01
• First posted: 2015-04-30
• Last updated: 2022-11-29
• Results posted: 2022-11-29

Locations

1 site across 1 country: Turkey (Türkiye)

Regulatory

• FDA-regulated drug study