NCT07454837 Study to Evaluate Switching to Brelovitug for the Treatment of CHD in Participants Receiving Bulevirtide
| NCT ID | NCT07454837 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Mirum Pharmaceuticals, Inc. |
| Condition | Chronic Hepatitis D |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2026-02-26 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 120 participants in total. It began in 2026-02-26 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07454837 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Hepatitis D. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07454837 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07454837 currently recruiting?
Yes, NCT07454837 is actively recruiting participants. Contact the research team at clinicaltrials@mirumpharma.com for enrollment information.
Where is the NCT07454837 trial being conducted?
This trial is being conducted at Graz, Austria, Innsbruck, Austria, Brno, Czechia, Prague, Czechia and 11 additional locations.
Who is sponsoring the NCT07454837 clinical trial?
NCT07454837 is sponsored by Mirum Pharmaceuticals, Inc.. The trial plans to enroll 120 participants.