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Rondaptivon Pegol

Clinical trials are investigating Rondaptivon Pegol in people with type 2B von Willebrand disease. These studies are looking at safety, efficacy, and effects on bleeding-related measures such as platelet counts. The target group is patients with this rare bleeding disorder.

Table of Contents

Trial overview

The available clinical trial for Rondaptivon Pegol is titled “Efficacy and Safety of BT200 (rondaptivon pegol) in Patients with Type 2B von Willebrand disease.”[1] The trial is an interventional study, which means researchers give a study treatment and then measure the results.[1]

This study is in Phase 2 and has been authorised.[1] The trial is focused on people with type 2B von Willebrand disease.[1]

Who is being studied

The target condition is Von Willebrand’s Disease Type 2B.[1] This is the only condition listed in the trial data, so the study is aimed at patients with this rare bleeding disorder.[1]

The enrollment is 6 people, which means the study is very small.[1] The trial data do not give more detailed participation rules, such as age limits or other entry requirements.[1]

What the study measures

The brief summary says the study is looking at the effects of BT200, which is named as rondaptivon pegol, on platelet count, VWF indices, FVIII, and bleeding in type 2B VWD.[1] In simple terms, the researchers want to see how the treatment affects blood clotting-related measures and bleeding.[1]

The primary outcomes are listed as platelet counts and the number of monthly bleeding events.[1] A primary outcome is the main result a trial is designed to measure.[1]

Trial design and treatment groups

The interventions listed are 0.9% sodium chloride solution and Rondaptivon Pegol.[1] Both are given by subcutaneous use, which means under the skin.[1]

The trial data show a dose of 12 mg/kg for Rondaptivon Pegol and 0.8 ml for the sodium chloride solution.[1] The data do not explain the full study schedule or how the comparison is organized beyond these listed interventions.[1]

Study status and size

The study status is Authorised, which means it has permission to proceed according to the source data.[1] The planned enrollment is 6 participants, so this is a small early-stage study.[1]

Because the trial is small, its main purpose is likely to gather early information about whether the treatment should be studied further in this condition.[1] The source data do not report final results.[1]

What this means for patients

For patients, this trial means researchers are testing whether Rondaptivon Pegol may help in type 2B von Willebrand disease by improving clotting-related measures and reducing bleeding.[1] The study is focused on a rare condition and uses clear outcome measures such as platelet count and monthly bleeding events.[1]

The trial data do not provide broader conclusions yet, because only the study plan and design details are available.[1]

Trial ID Phase Condition studied Status Enrollment
2024-518294-34-01 Phase 2 Von Willebrand’s Disease Type 2B Authorised 6

FAQ

  • What condition is being studied in the Rondaptivon Pegol trial? The trial is studying type 2B von Willebrand disease, a rare bleeding disorder. It focuses on people who have this specific condition.
  • What is the main goal of the trial? The main goal is to examine efficacy and safety. The study also measures platelet counts and the number of monthly bleeding events.
  • What phase is the Rondaptivon Pegol trial? This is a Phase 2 trial. Phase 2 studies usually look more closely at whether a treatment seems to work and continue checking safety.
  • Who can take part in this study? The study is for patients with type 2B von Willebrand disease. The trial data do not list other participation details.
  • What treatment is being compared in the trial? The trial compares Rondaptivon Pegol with 0.9% sodium chloride solution. Both are given by subcutaneous use, which means under the skin.

Ongoing Clinical Trials on Rondaptivon Pegol

  • Study on the Effects of BT200 (Rondaptivon Pegol) for Patients with Type 2B von Willebrand Disease

    Recruiting

    2 1
    Investigated diseases:
    Investigated drugs:
    Austria

Glossary

  • Type 2B von Willebrand disease: A rare bleeding disorder studied in this trial. It is the main condition the researchers are focusing on.
  • Phase 2: A mid-stage clinical trial phase. It usually checks whether a treatment seems effective and continues to monitor safety.
  • Interventional study: A study in which participants receive a treatment or comparison treatment so researchers can measure results.
  • Efficacy: How well a treatment works for the condition being studied.
  • Safety: Information about whether a treatment causes problems or is tolerated by participants.
  • Platelet count: The number of platelets in the blood. Platelets help the blood clot.
  • Bleeding events: Episodes of bleeding. In this study, researchers count the number of monthly bleeding events.
  • VWF indices: Measures related to von Willebrand factor, a blood protein involved in clotting.
  • FVIII: A clotting factor in the blood. The trial summary says it is one of the things being examined.
  • Subcutaneous use: Given under the skin, not into a vein or by mouth.

References

  1. https://clinicaltrials.gov/study/2024-518294-34-01