Assess Safety and Efficacy of VAD044 in HHT Patients

Running, not enrolling · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Hereditary Hemorrhagic Telangiectasia (HHT)

In brief

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.

Key facts

Study ID

NCT05406362

Run by

Vaderis Therapeutics AG

People needed

75

Starts

2022-07-18

Expected to finish

2027-01-01

Last updated by the study team

2026-03-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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