Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Brelovitug in chronic hepatitis delta infection
NCT06907290Phase 3
Key facts
- Status
- Active, not recruiting
- Start
- Mar 2025
- Primary completion
- May 2029
- Countries
- 11
- Sponsor
- Mirum Pharmaceuticals, Inc.
- Modality
- Engineered Antibody Formats, Antibody Conjugates, Monoclonal Antibodies
- Drugs
- brelovitug
- Conditions
- chronic hepatitis D
01
Overview
Phase 3, randomised, open-label trial of brelovitug in chronic hepatitis D (3 arms), sponsored by Mirum Pharmaceuticals, Inc. Primary endpoint: Percentage of participants with a composite endpoint at 24 weeks. Started Mar 2025; status: active, not recruiting.
02
Design
3 arms- Study design
- RandomizedOpen-label
Brelovitug 300mg
Brelovitug 300 mg subcutaneously once weekly
Brelovitug 900mg
Brelovitug 900 mg subcutaneously once every 4 weeks
Delayed Treatment
24 weeks of delayed treatment, then Brelovitug 300 mg subcutaneously once weekly
03
Who it enrols
Participants must have chronic HDV infection with HDV RNA >500 IU/mL and abnormal ALT, and be on or willing to start HBV therapy. Pregnant/nursing females, those with other liver diseases, hepatic decompensation, or prior organ/bone marrow transplants are excluded.
04
Endpoints
Primary
Percentage of participants with a composite endpoint
Secondary
Percentage of participants with treatment-emergent adverse events as assessed by DAIDS
Percentage of participants that achieve virologic response and ALT normalization
Percentage of participants with a composite endpoint by treatment regimen
Percentage of participants with HDV associated liver disease progression
Beyond the preview
Go deeper on NCT06907290.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT06907290.