VAD044 for Hereditary Hemorrhagic Telangiectasia

Recruiting at 8 trial locations

Overseen By Damien Picard

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Vaderis Therapeutics AG

Must not be taking: Anti-angiogenics, Anticoagulants

Disqualifiers: Diabetes, Active infections, others

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

75 Participants Needed

What You Need to Know Before You Apply

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.

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.

Who Is on the Research Team?

Damien Picard

Principal Investigator

Vaderis Therapeutics AG

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: 40 mg Experimental Treatment 2 Interventions

40 mg VAD044

Group II: 30 mg Experimental Treatment 2 Interventions

30 mg VAD044

Group III: Placebo Placebo Group 1 Intervention

Placebo

Who Is Running the Clinical Trial?

Vaderis Therapeutics AG

Lead Sponsor

Trials

1

Recruited

80+