ConditionChronic Hepatitis D Infection
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-99
SponsorMirum Pharmaceuticals, Inc.
About this trial
This is a Phase 3, global, randomized, open-label, multicenter, trial evaluating brelovitug (BJT-778) vs bulevirtide for the treatment of chronic hepatitis delta infection (CHD). The main goal of this study is to test the effectiveness of brelovitug compared to bulevirtide as a long-term treatment in patients with chronic HDV infection.
Eligibility criteria
Qualifiers
Willing and able to provide written informed consent
Chronic HDV infection
HDV RNA >500 IU/mL at Screening
ALT >ULN at Screening
Disqualifiers
Pregnant or nursing females
Unwilling to comply with contraception requirements during the study
Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy
Clinical hepatic decompensation (i.e., ascites, encephalopathy variceal hemorrhage).
Trial design
Treatments tested in this trial
- Brelovitug 300 mg
- Bulevirtide 2 mg and Brelovitug - 300 mg
Treatment groups
172 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov