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
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
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