NCT07200908 A Trial Evaluating Brelovitug (BJT-778) vs Bulevirtide for the Treatment of Chronic Hepatitis Delta Infection (AZURE-2)
| NCT ID | NCT07200908 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Mirum Pharmaceuticals, Inc. |
| Condition | Chronic Hepatitis D Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 172 participants |
| Start Date | 2025-08-27 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 172 participants in total. It began in 2025-08-27 with a primary completion date of 2027-06-30.
⚠ 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 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
Key Inclusion Criteria: 1. Willing and able to provide written informed consent 2. Chronic HDV infection 3. HDV RNA \>500 IU/mL at Screening 4. ALT \>ULN at Screening 5. Willing to take or already taking HBV neucleos(t)ide therapy. Key Exclusion Criteria: 1. Pregnant or nursing females 2. Unwilling to comply with contraception requirements during the study 3. Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy 4. Clinical hepatic decompensation (i.e., ascites, encephalopathy variceal hemorrhage). 5. Solid organ or bone marrow transplantation 6. Presence of other liver disease(s) (non-HBV/HDV), such as nonalcoholic steatohepatitis (NASH), alcohol associated hepatitis, cholestatic liver disease, hepatocellular carcinoma. Note - Other protocol-defined Inclusion/Exclusion criteria apply.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07200908 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Chronic Hepatitis D Infection. 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 NCT07200908 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 172 participants.
Is NCT07200908 currently recruiting?
Yes, NCT07200908 is actively recruiting participants. Contact the research team at clinicaltrials@mirumpharma.com for enrollment information.
Where is the NCT07200908 trial being conducted?
This trial is being conducted at Graz, Austria, Sankt Pölten, Austria, Brno, Czechia, Hradec Králové, Czechia and 11 additional locations.
Who is sponsoring the NCT07200908 clinical trial?
NCT07200908 is sponsored by Mirum Pharmaceuticals, Inc.. The trial plans to enroll 172 participants.