A Study of Lonafarnib With or Without Ritonavir in Patients With HDV — LOWR-5

Chronic Delta Hepatitis Clinical Trial

Official title:
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Status Withdrawn

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02968641
Study type	Interventional
Source	Eiger BioPharmaceuticals
Contact
Status	Withdrawn
Phase	Phase 2

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See also
	Status	Clinical Trial	Phase
	Completed	`NCT02527707` - Titrating-Dose of Lonafarnib in Combination With Ritonavir	Phase 2
	Not yet recruiting	`NCT02960360` - A Phase 2b Study of Lonafarnib With or Without Ritonavir in Patients With HDV	Phase 2