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Efficacy and Safety of BT200 (Rondaptivon Pegol) in Patients With Type 2B Von Willebrand Disease

RecruitingPhase 2Ages 18 Years - anyAllMedical University of Vienna
NCT07273721 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This randomized clinical trial with a cross-over design is being conducted at the Department of Clinical Pharmacology at the Medical University of Vienna, and a total of 4-6 patients with type 2B von Willebrand disease (VWD) will participate. The main purpose of this clinical trial is to investigate the efficacy and safety of BT200, a new drug for thrombocytopenic patients with type 2B von Willebrand disease (VWD). Based on previous studies, we expect that this drug will inhibit the breakdown of von Willebrand factor (VWF) in small doses, leading to an increase in von Willebrand factor (VWF), platelet count, and factor VIII. This should also lead to a reduced tendency to bleed. This study will begin with an observation phase and will then proceed in two periods of approximately 64 days each: Placebo or BT200 will be administered subcutaneously at a dose of 12 mg on the first day of th

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. ≥18 years old 2. Type 2B VWD with thrombocytopenia and a recent bleeding history (e.g. recurrent haematomas) 3. Able to comprehend and to give informed consent 4. Able to cooperate with the Investigator, to comply with the requirements of the study, and to complete the full sequence of protocol-related procedures Exclusion Criteria: 1. Clinically significant medical history or ongoing chronic illness that would jeopardise the safety of the patient or compromise the quality of the data derived from his/her participation in this study 2. History of significant drug allergy or anaphylactic reactions 3. Substance abuse, mental illness, or any reason that makes it unlikely in the judgment of the Investigator for the patient to be able to comply fully with study procedures 4. Use of medication during 2 weeks before the start of the study, which in the judgment of the Investigator may adversely affect the patient's welfare or the integrity of the study's results 5. Concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days or 5 elimination half-lives (whichever is longer) prior to treatment start
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What it tests

  • BT200
  • Placebo
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Where

1 site
Medical University of Vienna, Department of Clinical Pharmacology
Vienna, Austria
🤝 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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