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New shot aims to stop bleeding in rare blood disorder

NCT ID NCT07115004

Disease control Sponsor: Vega Therapeutics, Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 15, 2026 · Updated 3 times

Summary

This phase 3 study tests a drug called VGA039, given as a shot under the skin, to prevent bleeding in people with Von Willebrand disease. The trial will include 60 patients aged 12 to 75 who have frequent bleeding episodes. Researchers will track how well the drug reduces bleeds and check for side effects over about a year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
VGA039 (a drug given as a shot under the skin)
What this could lead to
If it works, this could offer a new preventive treatment to reduce bleeding episodes in people with Von Willebrand disease.
What could go wrong
This is still a phase 3 trial with only 60 participants, so results may not apply to everyone. There are risks like allergic reactions or side effects from the drug.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Oct 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria * 12 to 75 years of age, inclusive * No clinically significant laboratory, ECG, or vital signs results * Documented diagnosis consistent with VWD of any type * Historical annualized bleeding rate (ABR; excluding menstrual bleeds and bleeds under the skin) of both untreated and treated bleeds ≥12 per year * Patients with VWD who are judged by the investigator to be suitable candidates for routine prophylaxis to reduce the frequency of bleeding episodes * Hemoglobin level ≥ 8 g/dL and platelet count ≥ 100 x 109/L at Screening Key Exclusion Criteria * Use of routine prophylaxis of VWF-containing concentrates defined as at least 1 VWF-containing concentrate infusion to prevent or reduce bleeding per week during the previous 6 months prior to screening * Planning to initiate routine prophylaxis with VWF-containing concentrates or any other hemostatic treatment during the study * Patients with pro-thrombotic disorders or abnormal findings on laboratory thrombophilia evaluation performed at screening or previously documented * History of arterial or venous thrombosis, including superficial thrombophlebitis, or embolism * Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular disease, cerebrovascular disease, peripheral vascular disease, or metabolic dysfunction * Baseline FVIII activity \> lower limit of normal (LLN)

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Conditions

The condition(s) this trial relates to.

von Willebrand disease (hereditary or acquired)

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Von Willebrand disease (VWD)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    32 sites in 10 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Arkansas Children's Hospital

    RECRUITING

    Little Rock, Arkansas, 72202, United States

  • Azienda Ospedaliero-Universitaria Careggi (Careggi University Hospital)

    RECRUITING

    Florence, 50134, Italy

  • Centro de Hemoterapia e Hematologia do Rio de Janeiro (HEMORIO)

    RECRUITING

    Rio de Janeiro, Rio de Janeiro, 20211-030, Brazil

  • Charlotte Maxeke Johannesburg Academic Hospital School of Pathology Clinical Haematologist

    RECRUITING

    Johannesburg, 2194, South Africa

  • Children's Healthcare of Atlanta

    RECRUITING

    Atlanta, Georgia, 30329, United States

  • Emory University Hospital

    RECRUITING

    Atlanta, Georgia, 30308, United States

  • Frankfurt University Hospital (Universitätsmedizin Frankfurt)

    RECRUITING

    Frankfurt, 60596, Germany

  • Hemophilia Center of Western PA

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HC-FMUSP)

    RECRUITING

    São Paulo, São Paulo, 05403, Brazil

  • Imperial College Healthcare NHS Trust, Hammersmith Hospital

    RECRUITING

    London, Greater London, W12 0HS, United Kingdom

  • K Eristavi National Center of Experimental and Clinical Surgery (ქირურგიის ეროვნული ცენტრი)

    RECRUITING

    Tbilisi, 0159, Georgia

  • Luskin Orthopaedic Institute For Children

    RECRUITING

    Los Angeles, California, 90007, United States

  • Medical University of Vienna

    RECRUITING

    Vienna, 1090, Austria

  • Multihemo - Oncoclínicas

    RECRUITING

    Recife, Pernambuco, Brazil

  • Royal Brisbane & Women's Hospital (RBWH), Queensland Haemophilia Centre

    RECRUITING

    Brisbane, Queensland, 4029, Australia

  • Royal Free London NHS Foundation Trust,

    RECRUITING

    London, London, NW3 2QG, United Kingdom

  • Royal Prince Alfred Hospital, Institute of Haematology

    RECRUITING

    Sydney, New South Wales (nsw), 2050, Australia

  • Science 37, Inc. (Virtual Clinical MetaSite)

    RECRUITING

    Morrisville, North Carolina, 27560, United States

  • St. James's Hospital, National Coagulation Centre

    RECRUITING

    Dublin, Dublin, D08 NHY1, Ireland

  • Stanford University

    RECRUITING

    Palo Alto, California, 94304, United States

  • The Alfred Hospital (Alfred Health),Monash University

    RECRUITING

    Melbourne, Victoria, 3004, Australia

  • UC Davis Medical Center

    RECRUITING

    Sacramento, California, 95817, United States

  • UT Southwestern Children's Hospital

    RECRUITING

    Dallas, Texas, 75235, United States

  • University of California San Francisco

    RECRUITING

    San Francisco, California, 94143, United States

  • University of Michigan Health

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Milan

    RECRUITING

    Milan, Milan, 20122, Italy

  • University of Minnesota

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • Vivantes Klinikum im Friedrichshain

    RECRUITING

    Berlin, 10249, Germany

  • Washington Center for Bleeding Disorders

    RECRUITING

    Seattle, Washington, 98101, United States

    Contact Email: •••••@•••••

  • Worthwhile Clinical Trials Lakeview Hospital

    RECRUITING

    Benoni, Gauteng, 1501, South Africa

  • Yale University School of Medicine

    RECRUITING

    New Haven, Connecticut, 06510, United States

  • emocentro UNICAMP (Centro de Hematologia e Hemoterapia da UNICAMP), University of Campinas (UNICAMP)

    RECRUITING

    Campinas, São Paulo, 13083-878, Brazil

More trials for these conditions

Other studies related to the condition(s) this trial covers.