At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 41 enrolled
Drug / intervention
Bulevirtide (BLV)drug
Likely dose
Not stated in 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-Design, Multiple-Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Bulevirtide in Participants With Normal and Impaired Renal Function
In Brief
A Phase 1 clinical trial evaluating Bulevirtide (BLV) for Chronic Hepatitis D Infection. Completed, enrolled 41 participants across 9 sites.
Detailed Summary
The goals of this study are to compare the amount of study drug, bulevirtide (BLV), that gets into the bloodstream and how long it takes for the body to eliminate it, measure the effect of BLV on bile acids, and evaluate the safety and tolerability of multiple doses of BLV in participants with normal or impaired renal (kidney) function.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis D Infection
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
202420252026
First PostedMar 2023
Enrollment StartMar 2023
Primary CompletionJul 2024
Study CompletionJul 2024
TodayJul 2026
First PostedMar 8, 2023
Enrollment StartMar 15, 2023
Primary CompletionJul 18, 2024
Study CompletionJul 23, 2024
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 3.3 years ago
Interventions
Bulevirtide (BLV)drug
Administered via subcutaneous (SC) injections