At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 74 enrolled
Drug / intervention
Bulevirtide +1 moredrug
Likely dose
Bulevirtide 2 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1, Open-label, Parallel-group, Multiple-dose Study to Evaluate the Pharmacokinetics of Bulevirtide in Participants With Normal and Impaired Hepatic Function
In Brief
A Phase 1 clinical trial evaluating Bulevirtide for Hepatic Impairment and Healthy. Completed, enrolled 74 participants across 6 sites.
Detailed Summary
The goals of this study are to measure the amount of bulevirtide (BLV) that gets into the blood stream and how long it takes to get rid of it, measure the effect of BLV on bile acids, and evaluate the safety and tolerability of multiple doses of BLV in participants with normal and impaired hepatic (liver) function.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatic Impairment, Healthy
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
202420252026
First PostedMar 2023
Enrollment StartMar 2023
Primary CompletionJan 2025
Study CompletionJan 2025
TodayJul 2026
First PostedMar 13, 2023
Enrollment StartMar 15, 2023
Primary CompletionJan 10, 2025
Study CompletionJan 13, 2025
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 3.3 years ago
Interventions
Bulevirtidedrug
2 mg administered via subcutaneous injections.
Bulevirtidedrug
10 mg administered via subcutaneous injections.