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

NCT07200908

RecruitingPhase 3

Sponsor: Mirum Pharmaceuticals, Inc.

Conditions: Chronic Hepatitis D Infection

Interventions: Brelovitug 300 mg, Bulevirtide 2 mg and Brelovitug - 300 mg

Countries: Austria, Czechia, France, Germany, Italy, Romania, Spain, Sweden

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 overview

Sex: ALL

Age: 18 Years to 99 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (48)
  • Graz, Austria
  • Sankt Pölten, Austria
  • Brno, Brno, Czechia
  • Hradec Králové, Hradec Králové, Czechia
  • Liberec, Liberec, Czechia
  • Prague, Prague, Czechia
  • Prague, Prague, Czechia
  • Clermont-Ferrand, France
  • Clichy, France
  • Créteil, France
  • La Tronche, France
  • Le Chesnay, France
  • Lille, France
  • Limoges, France
  • Lyon, France
  • Paris, France
  • Pessac, France
  • Rennes, France
  • Toulouse, France
  • Frankfurt, Frankfurt, Germany
  • Rostock, Rostock, Germany
  • Düsseldorf, Germany
  • Hanover, Germany
  • Milan, Italy
  • Pisa, Italy
  • Roma, Italy
  • Bucharest, Bucharest, Romania
  • Bucharest, Bucharest, Romania
  • Iași, Lasi, Romania
  • Bucharest, Romania
  • + 18 more on CT.gov