Phase 2b/3 Study to Evaluate Switching to Brelovitug for the Treatment of CHD in Participants Receiving Bulevirtide

Mirum Pharmaceuticals

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Chronic Hepatitis D

Treatments: Drug: Bulevirtide; Drug: Brelovitug (BJT-778)

Study type: Interventional

Funder types: Industry

Identifiers

NCT07454837

BJT-778-303

Details and patient eligibility

About

This is a Phase 2b/3, randomized, open-label, multicenter trial evaluating the efficacy and safety of switching from bulevirtide to brelovitug for the treatment of chronic hepatitis Delta infection (CHD).

Full description

This is a Phase 2b/3, open-label, multicenter study evaluating the efficacy and safety of switching participants on bulevirtide to brelovitug for the treatment of chronic hepatitis delta (CHD).

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Willing and able to provide written informed consent.
2. Male or female, ≥18 years of age at Screening.
3. Taking or willing to take TDF, TAF, or ETV at baseline, and willing to remain on stable treatment for the duration of the study.
4. Currently taking bulevirtide treatment for CHD for ≥6 months at the time of Screening.
5. HDV RNA ≥100 IU/mL at Screening.

Exclusion criteria

1. Evidence of decompensated liver disease (e.g., CTP Class B or C, history of hepatic encephalopathy, clinically significant ascites, or variceal bleeding).
2. Known history of immune-complex disease.
3. Active or clinically significant co-infection with hepatitis C virus (HCV) or human immunodeficiency virus (HIV).
4. Evidence of other significant liver diseases (e.g., autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis).
5. History of hepatocellular carcinoma (HCC) or evidence of HCC on screening imaging.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

120 participants in 2 patient groups

Immediate Switch to Brelovitug

Experimental group

Description:

Participants will switch to brelovitug 300 mg once weekly for 96 weeks.

Treatment:

Drug: Brelovitug (BJT-778)

Delayed Switch from Bulevirtide to Brelovitug

Experimental group

Description:

Participants will continue bulevirtide once daily and then switch to brelovitug 300 mg once weekly for 72 weeks.

Treatment:

Drug: Bulevirtide