Once Daily Dosing of Lonafarnib Co-administered With Ritonavir for Treatment of Chronic Hepatitis D Virus Infection

NCT05229991 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-04-30

No results posted yet for this study

Summary

Open label, single arm, multi-center clinical trial of lonafarnib 50 mg QD plus ritonavir 200 mg QD, administered orally, over a 48-week treatment period, with a 24-week post-treatment follow-up period, in patients with chronic Hepatitis D Virusinfection.

Objectives: To evaluate the safety and tolerability of once daily dosing of lonafarnib 50 mg with ritonavir 200 mg over a 48-week treatment period.

To evaluate the effect of once daily dosing of lonafarnib 50 mg with ritonavir 200 mg over a 48-week treatment period with a 24-week post-treatment follow-up on HDV viral levels.

Trial population: Up to 30 patients with chronic HDV infection with detectable HDV RNA and compensated liver disease.

Conditions

  • Hepatitis D, Chronic

Interventions

DRUG

Lonafarnib

once-daily dosing of lonafarnib 50 mg with ritonavir 200 mg over a 48-week treatment period.

DRUG

Ritonavir

once-daily dosing of lonafarnib 50 mg with ritonavir 200 mg over a 48-week treatment period.

Sponsors & Collaborators

  • Eiger BioPharmaceuticals

    collaborator INDUSTRY
  • Soroka University Medical Center

    lead OTHER

Principal Investigators

  • Ohad Etzion, MD · Soroka University Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-15
Primary Completion
2025-02-05
Completion
2025-02-05

Countries

  • Israel
  • New Zealand
  • Turkey (Türkiye)

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05229991 on ClinicalTrials.gov