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Assess Safety and Efficacy of VAD044 in HHT Patients

V

Vaderis Therapeutics

Status and phase

Enrolling
Phase 1

Conditions

Hereditary Hemorrhagic Telangiectasia (HHT)

Treatments

Drug: VAD044

Study type

Interventional

Funder types

Industry

Identifiers

NCT05406362
VAD044C002

Details and patient eligibility

About

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

Full description

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 for study entry. At Day 0, patients who meet the eligibility requirements will be randomized in a double-blind manner (participant and investigator) in a 1:1:1 ratio to 30mg VAD044 (once daily), 40 mg (once daily) or placebo (once daily)

Enrollment

80 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • diagnosis of HHT by the Curaçao criteria
  • several epistaxis/week
  • anaemia
  • COVID-19 vaccination or positive COVID-19 antibody test

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

80 participants in 3 patient groups, including a placebo group

30 mg
Experimental group
Description:
30 mg VAD044
Treatment:
Drug: VAD044
40 mg
Experimental group
Description:
40 mg VAD044
Treatment:
Drug: VAD044
Placebo
Placebo Comparator group
Description:
Placebo
Treatment:
Drug: VAD044

Trial contacts and locations

8

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Central trial contact

Damien Picard; Hedvika Lazar

Data sourced from clinicaltrials.gov

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