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ACTIVE NOT RECRUITING
NCT05406362
PHASE1/PHASE2

Assess Safety and Efficacy of VAD044 in HHT Patients

Sponsor: Vaderis Therapeutics AG

View on ClinicalTrials.gov

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

DRUG

VAD044 Part I

capsules to be taken once daily for 12 weeks

DRUG

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