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NCT04537377 · ClinicalTrials.gov registry record · Phase 1
A Phase I/II Study of VTX-801 in Adult Patients With Wilson's Disease
A Phase 1 study of Wilson's Disease, sponsored by Vivet Therapeutics SAS.
- Active
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
- 10
- Study locations
NCT04537377: Active Phase 1 study of Wilson's Disease, sponsored by Vivet Therapeutics SAS.
NCT04537377 is a Phase 1 study of Wilson's Disease that is active but no longer recruiting, run by Vivet Therapeutics SAS. The registered enrollment target is 4 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower). The trial reports 10 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04537377, a Phase 1 study of Wilson's Disease, is active but no longer recruiting, sponsored by Vivet Therapeutics SAS.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
- 10
- Study locations
Study Summary
The objectives of this clinical trial are to assess, for up to 5 years, the safety, tolerability and pharmacological activity of a single ascending doses of VTX-801, a gene therapy, administered intravenously (IV) to adult patients with Wilson's Disease prior to and following background WD therapy withdrawal.
Primary Outcome
AEs will be summarized based on the date of onset for the event. Number of treatment-emergent AEs will be provided by SOC and PT, by dose cohort and overall.
Conditions Studied
Interventions
- GENETIC VTX-801
Study Locations (10)
Other
- Aarhus University Hospital - Aarhus
- University Hospital Essen - Essen
- Universitätsklinikum Tübingen (UKT) - Tübingen
California
- UC Davis Medical Center - Sacramento
Connecticut
- Yale University School of Medecine - New Haven
Florida
- Advent Health - Orlando
Michigan
- University of Michigan Health System - Ann Arbor
North Carolina
- Wake Forest School of Medicine - Winston-Salem
Texas
- University of Texas Southwestern Medical Center - Dallas
Surrey
- Royal Surrey County Hospital - Guildford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2021-09-03 |
| Est. Completion | 2029-06-18 |
| Phase | Phase 1 |
What the registry record for NCT04537377 still lists
NCT04537377 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Wilson's Disease appearing as the primary indexed condition, and to 1 intervention - of which VTX-801 is the first listed.
NCT04537377 lists 10 locations in 8 states (Other, California, Connecticut).
Frequently Asked Questions
What is clinical trial NCT04537377 about?
NCT04537377 is a clinical study titled "A Phase I/II Study of VTX-801 in Adult Patients With Wilson's Disease". The objectives of this clinical trial are to assess, for up to 5 years, the safety, tolerability and pharmacological activity of a single ascending doses of VTX-801, a gene therapy, administered intravenously (IV) to adult patients with Wilson's Disease prior to and following background WD therapy w...
What is the current status of trial NCT04537377?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2021-09-03. Estimated completion is 2029-06-18.
What conditions does trial NCT04537377 study?
This clinical trial studies the following conditions: Wilson's Disease.
What interventions are being tested in trial NCT04537377?
The interventions under investigation include: VTX-801 (GENETIC).
Who is sponsoring clinical trial NCT04537377?
This trial is sponsored by Vivet Therapeutics SAS, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04537377 being conducted?
This trial has 10 study locations across California, Connecticut, Florida, Michigan, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04537377's enrollment target sits among peer trials
4 1995th of 2000 higher than 2 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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