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Assess Safety and Efficacy of VAD044 in HHT Patients
Sponsor: Vaderis Therapeutics AG
Summary
Part I: The purpose of this Phase 1b proof of concept study, randomised, placebo controlled, double blind, multicentre study is to asssess safety and efficacy of 2 doses of VAD044 in adult HHT patients. Part II: The purpose of this open-label extension following the completion of the randomised double blind treatment and follow-up period (Part I of the study) is to assess the long-term safetty, tolerability and efficacy of VAD044 in adult HHT patients.
Official title: A Randomised, Placebo Controlled, Double Blind, Multicentre Proof of Concept Study to Assess the Safety and Efficacy of Two Doses of VAD044 in Patients With Hereditary Hemorrhagic Telangiectasia (HHT)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
75
Start Date
2022-07-18
Completion Date
2027-01
Last Updated
2026-03-17
Healthy Volunteers
No
Interventions
VAD044 Part I
capsules to be taken once daily for 12 weeks
VAD044 Part II
capsules to be taken once daily for 36 months
Locations (7)
Massachusetts General Hospital
Boston, Massachusetts, United States
Universitair Ziekenhuis Gent
Ghent, Belgium
Hospices Civils de Lyon
Lyon, France
Ospedale Maggiore di Crema
Crema, Italy
St. Antonius Hospital
Nieuwegein, Netherlands
Hospital Universiati De Bellvitge
Barcelona, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain