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โ† Trials
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Study to Evaluate Subcutaneous (SC) VGA039 in Patients With Von Willebrand Disease (VWD)

RecruitingPhase 3Ages 12 Years - 75 YearsAllVega Therapeutics, Inc
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ12 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 โ‰ฅ 8 g/dL and platelet count โ‰ฅ 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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What it tests

  • VGA039
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Where

32 sites
Arkansas Children's Hospital
Little Rock, United States
Luskin Orthopaedic Institute For Children
Los Angeles, United States
Stanford University
Palo Alto, United States
UC Davis Medical Center
Sacramento, United States
University of California San Francisco
San Francisco, United States
Yale University School of Medicine
New Haven, United States
Emory University Hospital
Atlanta, United States
Children's Healthcare of Atlanta
Atlanta, United States

โ€ฆand 24 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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