Actively Recruiting

Phase 1
Phase 2
Age: 12Years - 60Years
All Genders
Healthy Volunteers
NCT05776069

Study of VGA039 in Healthy Volunteers and Patients With Von Willebrand Disease (VIVID)

Led by Vega Therapeutics, Inc · Updated on 2025-08-26

116

Participants Needed

25

Research Sites

350 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The VIVID study is structured in a master protocol format comprised of multiple parts that evaluate intravenous (IV) and subcutaneous (SC) VGA039 in healthy volunteers and subjects with von Willebrand Disease (VWD) and other bleeding disorders.

CONDITIONS

Official Title

Study of VGA039 in Healthy Volunteers and Patients With Von Willebrand Disease (VIVID)

Who Can Participate

Age: 12Years - 60Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 60 years for Parts 1 and 2
  • Age 12 to 60 years for Parts 3 and 5
  • No clinically significant abnormal laboratory results, ECG, or vital signs
  • Body mass index between 18 and 32 kg/m2 (Part 1 only)
  • For Part 2, subjects must have symptomatic von Willebrand Disease with a history of bleeding or bruising
  • Hemoglobin level of at least 8 g/dL and platelet count of at least 150 x 10^9/L at screening (Part 2 only)
Not Eligible

You will not qualify if you...

  • Use of hormonal contraceptives within 56 days before study drug administration
  • Detection of certain blood clotting mutations or deficiencies at screening, including FV Leiden, Prothrombin G20210A mutation, protein C or S deficiency, antithrombin deficiency, or antiphospholipid antibody syndrome
  • Known pro-thrombotic disorders or abnormal thrombophilia lab results
  • History of arterial or venous thrombosis, including superficial thrombophlebitis or embolism
  • Kidney, liver, nervous system, respiratory, heart, brain, blood vessel, or metabolic diseases
  • Baseline factor VIII activity greater than 150 IU/dL (Part 1 only)
  • Baseline factor VIII activity greater than 50 IU/dL (Parts 2, 3, 4, and 5)
  • Any acute bleeding event needing surgical or procedural intervention within 7 days before receiving study drug (Parts 2, 3, 4, and 5)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 25 locations

1

Orthopedic Institute for Children (UCLA)

Los Angeles, California, United States, 90007

Actively Recruiting

2

UC Davis Medical Center

Sacramento, California, United States, 95817

Actively Recruiting

3

University of Colorado School of Medicine

Aurora, Colorado, United States, 80045

Actively Recruiting

4

Hemophilia of Georgia Center for Bleeding & Clotting Disorders of Emory

Atlanta, Georgia, United States, 30308

Actively Recruiting

5

Science 37, Inc.

Morrisville, North Carolina, United States, 27560

Actively Recruiting

6

Hemophilia Center of Western PA

Pittsburgh, Pennsylvania, United States, 15213

Actively Recruiting

7

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232

Actively Recruiting

8

University of Texas Southwestern

Dallas, Texas, United States, 75235

Actively Recruiting

9

Washington Center for Bleeding Disorders

Seattle, Washington, United States, 98101

Actively Recruiting

10

Versiti Comprehensive Center for Bleeding Disorders

Milwaukee, Wisconsin, United States, 53233

Actively Recruiting

11

Royal Brisbane & Women's Hospital, Queensland Haemophilia Centre

Herston, Queenland, Australia, 4029

Actively Recruiting

12

Medical University of Vienna

Vienna, State of Vienna, Austria

Completed

13

Centro de Hemoterapia e Hematologia do Rio de Janeiro HEMORIO

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

Actively Recruiting

14

Hemocentro Unicamp

Campinas, São Paulo, Brazil, 13083-878

Actively Recruiting

15

Hospital das Clinicas - USP Endereco

São Paulo, São Paulo, Brazil, 05403-010

Actively Recruiting

16

Hamilton Health Sciences Corporation

Hamilton, Ontario, Canada, L8N 3Z5

Actively Recruiting

17

Queens University

Kingston, Ontario, Canada, K7L 3N6

Actively Recruiting

18

St. Michaels Hospital

Toronto, Ontario, Canada, M5B 1W8

Actively Recruiting

19

K J Somaiya Super Speciality Hospital & Research Centre

Sion, Mumbai, India, 400022

Actively Recruiting

20

Charlotte Maxeke Johannesburg Academic Hospital

Johannesburg, South Africa

Actively Recruiting

21

Queen Elizabeth Hospital Birmingham

Birmingham, Edgbaston, United Kingdom, B15 2TT

Actively Recruiting

22

University Hospital Southampton NHS Foundation Trust

Southampton, Hampshire, United Kingdom, SO16 6YD.

Actively Recruiting

23

Royal Free Hospital

London, London, United Kingdom, NW3 2QG

Actively Recruiting

24

Royal London Hospital, Clinical Haematology Research

Whitechapel, London, United Kingdom, E12ES

Actively Recruiting

25

Imperial College Healthcare NHS Trust- Queen Charlotte's & Chelsea Hospital

London, United Kingdom

Actively Recruiting

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Research Team

C

Clinical Trials

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

5

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