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NCT05406362 · ClinicalTrials.gov registry record · Phase 1
Assess Safety and Efficacy of VAD044 in HHT Patients
A Phase 1 study of Hereditary Hemorrhagic Telangiectasia (HHT), sponsored by Vaderis Therapeutics.
- Active
- Registry status
- Phase 1
- Development phase
- 75
- Enrollment target
- 7
- Study locations
NCT05406362: Active Phase 1 study of Hereditary Hemorrhagic Telangiectasia (HHT), sponsored by Vaderis Therapeutics.
NCT05406362 is a Phase 1 study of Hereditary Hemorrhagic Telangiectasia (HHT) that is active but no longer recruiting, run by Vaderis Therapeutics. The registered enrollment target is 75 participants, above the 61-participant average among 3 other Hereditary Hemorrhagic Telangiectasia (HHT) trials with a reported enrollment target (23% higher). The trial reports 7 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05406362, a Phase 1 study of Hereditary Hemorrhagic Telangiectasia (HHT), is active but no longer recruiting, sponsored by Vaderis Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 75 participants
- Enrollment target
- 7
- Study locations
Study Summary
Part I: 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. Part II: The purpose of this open-label extension following the completion of the randomised double blind treatment and follow-up period (Part I of the study) is to assess the long-term safetty, tolerability and efficacy of VAD044 in adult HHT patients.
Primary Outcome
Type and severity of Adverse Events (AEs)
Conditions Studied
Interventions
- DRUG VAD044 Part I
- DRUG VAD044 Part II
Study Locations (7)
Other
- Universitair Ziekenhuis Gent - Ghent
- Hospices Civils de Lyon - Lyon
- Ospedale Maggiore di Crema - Crema
- St. Antonius Hospital - Nieuwegein
- Hospital Universiati De Bellvitge - Barcelona
- Hospital Universitario Ramón y Cajal - Madrid
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2022-07-18 |
| Est. Completion | 2027-01 |
| Phase | Phase 1 |
What the registry record for NCT05406362 still lists
NCT05406362 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, above the 61-participant average among 3 other Hereditary Hemorrhagic Telangiectasia (HHT) trials with a reported enrollment target (23% higher).
The record links to 1 condition, with Hereditary Hemorrhagic Telangiectasia (HHT) appearing as the primary indexed condition, and to 2 interventions - of which VAD044 Part I is the first listed.
NCT05406362 lists 7 locations in 2 states (Other, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT05406362 about?
NCT05406362 is a clinical study titled "Assess Safety and Efficacy of VAD044 in HHT Patients". Part I: 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. Part II: The purpose of this open-label extension following the completion of the randomised dou...
What is the current status of trial NCT05406362?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 75 participants. The study started on 2022-07-18. Estimated completion is 2027-01.
What conditions does trial NCT05406362 study?
This clinical trial studies the following conditions: Hereditary Hemorrhagic Telangiectasia (HHT).
What interventions are being tested in trial NCT05406362?
The interventions under investigation include: VAD044 Part I (DRUG), VAD044 Part II (DRUG).
Who is sponsoring clinical trial NCT05406362?
This trial is sponsored by Vaderis Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05406362 being conducted?
This trial has 7 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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