NCT02968641

A Study of Lonafarnib With or Without Ritonavir in Patients With HDV

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 (LOWR-5)

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Eiger BioPharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Detailed description

This Phase 2b, randomized, open-label study will assess the safety, tolerability, and pharmacodynamics (PD)/efficacy of 48 weeks of lonafarnib (LNF) and ritonavir (RTV) combination therapy vs. LNF monotherapy in patients with chronically infected with Hepatitis Delta Virus (CHD). Sixty patients will be enrolled at a single study site. Eligible patients will have CHD infection (≥ 6 months) confirmed by positive HDV antibody (Ab) test and HDV RNA ≥ 3 lg IU/mL by quantitative polymerase chain reaction (qPCR) at study entry.

Conditions

• Chronic Delta Hepatitis

Interventions

Type	Name	Description
DRUG	Lonafarnib	antiviral farnesyltransferase inhibitor
DRUG	Ritonavir	CYP 3A4 inhibitor, lonafarnib booster

Timeline

• Primary completion: 2021-02-12
• First posted: 2016-11-18
• Last updated: 2021-02-16

Regulatory

• FDA-regulated drug study