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VGA039

Clinical trials are investigating VGA039 in people with von Willebrand Disease. The studies are looking at whether VGA039 can help prevent bleeding, with a focus on safety and efficacy in adolescent and adult patients. The main trial is a Phase 3 study in people who have not previously used prophylactic von Willebrand Factor-containing concentrates.

Table of contents

Clinical trials overview

One authorised Phase 3 interventional study is testing VGA039 in people with von Willebrand Disease.[1]

The study is designed to assess the effect of subcutaneous VGA039 prophylaxis, which means preventive treatment given under the skin, on bleeding events.[1]

Who the study is for

The trial is for adolescent and adult patients with von Willebrand Disease.[1]

It focuses on people who previously did not receive von Willebrand Factor-containing concentrates on a prophylactic basis, meaning they did not use these products regularly to prevent bleeding.[1]

What the trial measures

The main endpoint is annualized bleeding rate (ABR).[1]

ABR is a way to measure how many bleeding events happen over one year, so researchers can see whether the treatment helps reduce bleeding.[1]

Trial status and size

The study status is Authorised, which means it has been allowed to start.[1]

The planned enrollment is 54 participants.[1]

What this means for patients

This trial is part of clinical research to learn whether VGA039 can help prevent bleeding in a specific group of people with von Willebrand Disease.[1]

Because it is a Phase 3 study, the researchers are studying the treatment in a larger group to better understand its benefit in real patients.[1]

Trial IDPhaseCondition studiedStatusEnrollment
NCT07115004Phase 3von Willebrand DiseaseAuthorised54

FAQ

  • What is being studied in VGA039 clinical trials? The trial is studying VGA039 as a preventive treatment for bleeding in people with von Willebrand Disease. The main goal is to see if it lowers bleeding events.
  • Who can take part in the main trial? The main study includes adolescent and adult patients with von Willebrand Disease. It is aimed at people who have not previously received von Willebrand Factor-containing concentrates on a preventive basis.
  • What phase is the VGA039 trial? The available trial is a Phase 3 study. Phase 3 means the treatment is being tested in a larger group to better understand its effect.
  • What condition is the trial focused on? The trial is focused on von Willebrand Disease, a bleeding disorder. The study looks at bleeding prevention in this condition.
  • What is the main outcome being measured? The main outcome is the annualized bleeding rate, also called ABR. This means the researchers count how often bleeding happens over a year.

Ongoing Clinical Trials on VGA039

  • A Study of VGA039 to Prevent Bleeding in Teenagers and Adults with von Willebrand Disease Who Have Not Used Regular Preventive Treatment Before

    Recruiting

    1 1 1
    Investigated drugs:
    Austria Finland Germany Ireland Italy

Glossary

  • von Willebrand Disease: A bleeding disorder in which blood does not clot normally, so bleeding can happen more easily or last longer.
  • Prophylaxis: Treatment given to help prevent a problem before it happens, such as bleeding episodes.
  • Adolescent: A young person who is older than a child but not yet an adult.
  • Adult: A person who is fully grown and legally considered mature.
  • Phase 3: A later stage of clinical research that studies a treatment in a larger group of people.
  • Interventional study: A clinical trial in which researchers give a treatment and measure what happens.
  • Annualized bleeding rate (ABR): The number of bleeding events expected over one year.
  • Von Willebrand Factor-containing concentrates: Medicines that contain von Willebrand Factor and are used in some people with von Willebrand Disease.
  • Subcutaneous injection: An injection given under the skin.
  • Enrollment: The number of people planned or included in a study.
  • Authorised: The study has been allowed to start.

References