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Clinical Trials in Spain / NCT05406362
Active, not recruiting Phase 1/2

Assess Safety and Efficacy of VAD044 in HHT Patients

NCT05406362 · tracked via the Priya Life Science Spain tracker
Sponsor
Vaderis Therapeutics AG
Phase
Phase 1/2
Started
2022-07-18
Last updated
2026-03-17

Condition(s) studied

Hereditary Hemorrhagic Telangiectasia (HHT)

Investigational drug(s) / intervention(s)

VAD044 Part I →VAD044 Part II →

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)

FacilityCityRegionStatus
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.

View NCT05406362 on ClinicalTrials.gov ↗ ← All trials in Spain