75 Participants Needed

VAD044 for Hereditary Hemorrhagic Telangiectasia

Recruiting at 8 trial locations
HL
DP
Overseen ByDamien Picard
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Vaderis Therapeutics AG

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have used drugs with anti-angiogenic properties in the past 8 weeks or if you require therapeutic anticoagulation.

What is the purpose of this trial?

This trial is testing a new medication called VAD044 to see if it can help adults with Hereditary Hemorrhagic Telangiectasia (HHT). The study will compare two different doses of VAD044 to check its safety and effectiveness. Participants will be assigned to one of the groups, and neither they nor the researchers will know which treatment they are receiving.

Research Team

DP

Damien Picard

Principal Investigator

Vaderis Therapeutics AG

Eligibility Criteria

This trial is for adults with Hereditary Hemorrhagic Telangiectasia (HHT) who experience several nosebleeds per week and have anemia. Participants must be vaccinated against or have antibodies for COVID-19. Those on blood thinners, recent anti-angiogenic drugs, with certain diabetes conditions, active infections including COVID-19, or recent nasal procedures cannot join.

Inclusion Criteria

I experience nosebleeds several times a week.
I have anemia.
You have been diagnosed with HHT using the Curaçao criteria.
See 1 more

Exclusion Criteria

I have type 1 diabetes or my type 2 diabetes is not under control.
Abnormal test results from blood or other lab tests.
I do not have an active infection and am not HIV or hepatitis B/C positive.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

8 weeks

Treatment

Participants are randomized to receive either 30mg VAD044, 40mg VAD044, or placebo once daily

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension

Participants may opt into continuation of treatment with VAD044 for long-term safety and efficacy assessment

12 months

Treatment Details

Interventions

  • VAD044
Trial Overview The study tests the safety and effectiveness of two doses of a new medication called VAD044 in HHT patients. It's a Phase 1b trial where participants are randomly assigned to receive either VAD044 or a placebo without knowing which one they get.
Participant Groups
3Treatment groups
Experimental Treatment
Placebo Group
Group I: 40 mgExperimental Treatment2 Interventions
40 mg VAD044
Group II: 30 mgExperimental Treatment2 Interventions
30 mg VAD044
Group III: PlaceboPlacebo Group1 Intervention
Placebo

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vaderis Therapeutics AG

Lead Sponsor

Trials
1
Recruited
80+
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