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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
Must not have
Active uncontrolled infection or known to be serologically positive for HIV, Hep B, Hep C infection
Type 1 diabetes or uncontrolled type II diabetes (insulin or non-insulin dependent)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Summary
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.
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have an active infection and am not HIV or hepatitis B/C positive.
Select...
I have type 1 diabetes or my type 2 diabetes is not under control.
Select...
I haven't taken any anti-angiogenic drugs in the last 8 weeks.
Select...
I currently have an active COVID-19 infection.
Select...
I need medication to prevent blood clots.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Safety and Tolerability
Secondary study objectives
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Osler-Weber-Rendu Syndrome treatments often include anti-angiogenic agents to inhibit new blood vessel formation and reduce bleeding, antifibrinolytic agents to stabilize blood clots, and supportive treatments like iron supplements and blood transfusions to manage anemia. These treatments are crucial for managing symptoms and preventing complications in HHT patients.
The trial VAD044 is likely exploring a new treatment targeting these pathways to enhance safety and efficacy.
Kasabach-Merritt syndrome.[Prostacyclin in the treatment of hemolytic-uremic syndrome: apropos of a case].[Our experience with sirolimus for the treatment of complicated vascular anomalies].
Kasabach-Merritt syndrome.[Prostacyclin in the treatment of hemolytic-uremic syndrome: apropos of a case].[Our experience with sirolimus for the treatment of complicated vascular anomalies].
Find a Location
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.
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