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โ† Trials
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Study to Evaluate Switching to Brelovitug for the Treatment of CHD in Participants Receiving Bulevirtide

RecruitingPhase 2, Phase 3Ages 18 Years - anyAllMirum Pharmaceuticals, Inc.
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In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Willing and able to provide written informed consent. 2. Male or female, โ‰ฅ18 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 โ‰ฅ6 months at the time of Screening. 5. HDV RNA โ‰ฅ100 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.
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What it tests

  • Brelovitug (BJT-778)
  • Bulevirtide
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Where

44 sites
Medical University of Graz
Graz, Austria
Medizinische Universitat Innsbruck
Innsbruck, Austria
University Hospital St. Polten- Lilenfeld
Lilienfeld, Austria
Medical University of Vienna
Vienna, Austria
Fakultni Nemocnice Brno (University Hospital Brno)
Brno, Czechia
Klin Med Ltd. (KLIN MED s.r.o.)
Prague, Czechia
Institut klinicke a experimentalni mediciny- IKEM (Institute for Clinical and Experimental Medicine)
Prague, Czechia
CHU de Bordeaux
Bordeaux, France

โ€ฆand 36 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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