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VAD044 for Hereditary Hemorrhagic Telangiectasia
Phase 1
Recruiting
Research Sponsored by Vaderis Therapeutics AG
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Several epistaxis per week
Anemia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Study Summary
This trial is testing a new drug to see if it is safe and effective for people with a genetic condition that causes abnormal blood vessel growth.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
As this is an early-stage trial for VAD044, specific side effects are being studied but may include typical drug reactions such as headaches, nausea, allergic reactions or other unforeseen issues related to the medication.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I experience nosebleeds several times a week.
Select...
I have anemia.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety and Tolerability
Secondary outcome measures
Change in Epistaxis Frequency
Change in the Nasal Outcome for Epistaxis in Hereditary Hemorrhagic Telangiectasia score
Pharmacokinetics (PK) of VAD044
+1 moreTrial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: 40 mgExperimental Treatment1 Intervention
40 mg VAD044
Group II: 30 mgExperimental Treatment1 Intervention
30 mg VAD044
Group III: PlaceboPlacebo Group1 Intervention
Placebo
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Who is running the clinical trial?
Vaderis Therapeutics AGLead Sponsor
Damien PicardStudy DirectorVaderis Therapeutics AG
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I experience nosebleeds several times a week.I have type 1 diabetes or my type 2 diabetes is not under control.I have anemia.Abnormal test results from blood or other lab tests.You have been diagnosed with HHT using the Curaçao criteria.I do not have an active infection and am not HIV or hepatitis B/C positive.I have had recent treatment for nose blood vessel issues.I haven't taken any anti-angiogenic drugs in the last 8 weeks.I currently have an active COVID-19 infection.I need medication to prevent blood clots.You have recently received a COVID-19 vaccine or tested positive for COVID-19 antibodies.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: 30 mg
- Group 3: 40 mg
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current size of the patient cohort involved in this clinical trial?
"Affirmative. Clinicaltrials.gov attests to the fact that this medical trial is actively enlisting participants after its first posting on July 18th 2022. 80 volunteers from 3 centres are sought for the study which was last updated on September 19th, 2022."
Answered by AI
Are there vacancies in this research endeavor for participants?
"According to clinicaltrials.gov, this trial is currently recruiting participants after first being posted on July 18th 2022 and last updated on September 19th 2022."
Answered by AI
What is the security profile of VAD044 for patients?
"The safety of VAD044 was graded a 1 since this is an early Phase 1 trial, meaning there are only initial studies confirming its efficacy and scant data guaranteeing it's harmlessness."
Answered by AI
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