Summary

Eligibility
for people ages 12-75 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
study ends around

Description

Summary

This is a phase 3 study that will evaluate subcutaneous (SC) VGA039 in patients with von Willebrand Disease (VWD)

Official Title

A Prospective, Multicenter, Open-label, Phase 3 Clinical Study to Evaluate the Efficacy and Safety of Prophylactic VGA039 in Adolescent and Adult Patients With Von Willebrand Disease (VIVID-6)

Details

This Phase 3 multicenter, open-label, single-sequence cross-over study will investigate the safety and efficacy of subcutaneous administration of VGA039 as prophylaxis for bleeding in patients with every type of VWD. The study consists of an Observational Period of at least 24 weeks followed by an Active Treatment Period of approximately 49 weeks of VGA039 treatment. Bleeding data and details of treatments used will be collected from each patient during both study periods. The number, duration, location, and types of bleeds experienced, as well as treatments for bleeds, will be recorded in patient diaries. Adverse events will also be monitored and recorded throughout both study periods.

Keywords

Von Willebrand Disease (VWD), VWD, von Willebrand Disease, VIVID-6, Vega Therapeutics, Star Therapeutics, VGA039, von Willebrand Diseases

Eligibility

You can join if…

Open to people ages 12-75

  • 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

You CAN'T join if...

  • 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)

Locations

  • UCSF accepting new patients
    San Francisco California 94143 United States
  • UC Davis Medical Center accepting new patients
    Sacramento California 95817 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Vega Therapeutics, Inc
ID
NCT07115004
Phase
Phase 3 Von Willebrand Disease Research Study
Study Type
Interventional
Participants
Expecting 60 study participants
Last Updated