Status:
ACTIVE_NOT_RECRUITING
Assess Safety and Efficacy of VAD044 in HHT Patients
Lead Sponsor:
Vaderis Therapeutics AG
Conditions:
Hereditary Hemorrhagic Telangiectasia (HHT)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 patient...
Detailed Description
Part I: After being informed about the study and the potential risks, all patients giving written informed consent will undergo a two months screening and observation period to determine eligibility f...
Eligibility Criteria
Inclusion
- For Part I of the study:
- 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
- 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
Key Trial Info
Start Date :
July 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT05406362
Start Date
July 18 2022
End Date
December 1 2025
Last Update
March 4 2025
Active Locations (7)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Universitair Ziekenhuis Gent
Ghent, Belgium
3
Hospices Civils de Lyon
Lyon, France
4
Ospedale Maggiore di Crema
Crema, Italy