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A Trial Evaluating Brelovitug (BJT-778) vs Bulevirtide for the Treatment of Chronic Hepatitis Delta Infection (AZURE-2)

RecruitingPhase 3Ages 18 Years - 99 YearsAllMirum Pharmaceuticals, Inc.
NCT07200908 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Brelovitug 300 mg
  • Bulevirtide 2 mg and Brelovitug - 300 mg
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Where

57 sites
Medical University of Graz
Graz, Austria
Universitätsklinikum St. Pölten
Sankt Pölten, Austria
Fakultni Nemocnice Brno
Brno, Czechia
Fakultni Nemocnice Hradec Kralove
Hradec Králové, Czechia
Krajská nemocnice Liberec, a.s.
Liberec, Czechia
Institute For Clinical And Experimental Medicine
Prague, Czechia
Klin Med s.r.o.
Prague, Czechia
Hôpital Estaing
Clermont-Ferrand, France

…and 49 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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