Brelovitug versus bulevirtide for treating chronic hepatitis D (AZURE-2)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3, global, randomized, open-label, multicenter trial will enroll about 172 adults with chronic HDV infection and randomize them 3:1 to two treatment arms. One arm receives brelovitug 300 mg subcutaneously once weekly for 96 weeks; the other receives bulevirtide 2 mg subcutaneously once daily for 48 weeks followed by brelovitug 300 mg weekly for the next 48 weeks. All participants must be on or willing to start HBV nucleos(t)ide therapy and will have regular blood testing for HDV RNA and liver function. The study compares long-term virologic and biochemical responses and safety between continuous brelovitug and the sequential bulevirtide-then-brelovitug regimen.

Why it matters

Who can join: the full rules

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.

Where it's running

• Medical University of Graz
  Graz, Austria Recruiting
• Universitätsklinikum St. Pölten
  Sankt Pölten, Austria Recruiting
• Fakultni Nemocnice Brno
  Brno, Brno, Czechia Recruiting
• Fakultni Nemocnice Hradec Kralove
  Hradec Králové, Hradec Králové, Czechia Recruiting
• Krajská nemocnice Liberec, a.s.
  Liberec, Liberec, Czechia Recruiting
• Institute For Clinical And Experimental Medicine
  Prague, Prague, Czechia Recruiting

+7 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Clinical Trials Clinical Trials Mirum
• Email: clinicaltrials@mirumpharma.com
• Phone: +16506674085

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Libevitug for chronic HDV infection: a big, international phase 3 study

  This phase 3 study tests Libevitug in people with chronic HDV infection to see if it works and is safe.

  Recruiting at 7 sites Phase 3 Huahui Health · Garden Grove, California and 6 other locations · NCT07499544

• Switching from bulevirtide to brelovitug for chronic hepatitis D treatment

  This trial tests whether switching people with chronic hepatitis D who are already taking bulevirtide to brelovitug keeps their infection under control and is safe.

  Recruiting at 46 sites Phase 2/3 Mirum Pharmaceuticals, Inc. · Graz and 45 other locations · NCT07454837

• Long-term safety and outcomes of Livmarli for Alagille syndrome in the EU

  This study will follow people with Alagille syndrome who take Livmarli to see if it is safe, well tolerated over the long term, and continues to reduce cholestatic itching.

  Recruiting at 13 sites Phase 4 Mirum Pharmaceuticals, Inc. · Brussels and 14 other locations · NCT07290257

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  Recruiting at 17 sites Phase 2 Mirum Pharmaceuticals, Inc. · Phoenix, Arizona and 17 other locations · NCT07209462

• Evaluating the long-term safety and outcomes of Livmarli in patients with liver diseases

  This study is testing how safe and effective the medication Livmarli is for people with Alagille syndrome or Progressive familial intrahepatic cholestasis over a five-year period.

  Recruiting at 8 sites Mirum Pharmaceuticals, Inc. · Los Angeles, California and 7 other locations · NCT06193928

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.