VAD044 Part I: capsules to be taken once daily for 12 weeks
VAD044 Part II: capsules to be taken once daily for 36 months
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
For Part I of the study:
Inclusion Criteria:
* Diagnosis of HHT by the Curaçao criteria
* Several epistaxis/week
* Anaemia
* COVID-19 vaccination or positive COVID-19 antibody test
* Patient has given written informed consent to participate in Part I
Exclusion Criteria:
* Type 1 diabetes or uncontrolled type II diabetes (insulin or non-insulin dependent)
* Active COVID-19 infection
* active uncontrolled infection or known to be serologically positive for HIV, Hep B, Hep C infection
* Recent procedures on nasal telangiectases (\<6 weeks)
* Requiring therapeutic anticoagulation
* Use of drugs with anti-angiogenic properties in the past 8 weeks
* laboratory abnormalities
Fort Part II of the study:
Inclusion Criteria:
* Completion of Part I of the study
* All adverse events or serious adverse events occuring during Part I of the study have resolved
* Patient has given written informed consent to participate in Part II
Exclusion Criteria:
\- Same as in Part I.
Primary outcome measure(s)
Part I: Safety and Tolerability — 12 weeks Type and severity of Adverse Events (AEs)
Part II: Safety and Tolerability — 36 months Type and severity of Adverse Events (AEs)
Trial sites (7)
Facility
City
Region
Status
Massachusetts General Hospital
Boston
Massachusetts
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
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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