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NCT04980638 · ClinicalTrials.gov registry record · Phase 2
Intraamniotic Administrations of ER004 to Male Subjects With X-linked Hypohidrotic Ectodermal Dysplasia
A Phase 2 study of X-Linked Hypohidrotic Ectodermal Dysplasia (XLHED), sponsored by EspeRare Foundation.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 8
- Study locations
NCT04980638 is a Phase 2 study of X-Linked Hypohidrotic Ectodermal Dysplasia (XLHED) that is actively recruiting participants, run by EspeRare Foundation. The registered enrollment target is 20 participants. The trial reports 8 study locations across 7 states.
The verdict
NCT04980638, a Phase 2 study of X-Linked Hypohidrotic Ectodermal Dysplasia (XLHED), is actively recruiting participants, sponsored by EspeRare Foundation.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 8
- Study locations
Study Summary
This is an open-label, prospective, genotype-match controlled for primary estimand, non randomized, multicenter, international Phase 2 clinical trial designed to investigate the efficacy and safety of ER004 administered intraamniotically as a treatment for unborn XLHED male subjects.
Conditions Studied
Interventions
- BIOLOGICAL ER004
Study Locations (8)
Other
- IRCCS Ca' Granda Ospedale Policlinico - Milan
- University Hospital of Wales Cardiff and Vale University Local Health - Cardiff
California
- Cedars-Sinai Medical Center - Los Angeles
Missouri
- Washington University - St Louis
Paris
- Hôpital Necker - Enfants Malades - Paris
Bavaria
- Universitaetsklinikum Erlangen - Erlangen
Saxony
- Universitaetsklinikum Leipzig AoeR - Leipzig
Murcia
- Hospital Universitario Virgen de la Arrixaca - El Palmar
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2022-04-26 |
| Est. Completion | 2032-12 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04980638
The ClinicalTrials.gov registry entry for NCT04980638 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is EspeRare Foundation, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with X-Linked Hypohidrotic Ectodermal Dysplasia (XLHED) appearing as the primary indexed condition, and to 1 intervention - of which ER004 is the first listed.
NCT04980638 reports 8 study locations spanning 7 distinct geographic areas - top geographies include Other, California, Missouri.
Frequently Asked Questions
What is clinical trial NCT04980638 about?
NCT04980638 is a clinical study titled "Intraamniotic Administrations of ER004 to Male Subjects With X-linked Hypohidrotic Ectodermal Dysplasia". This is an open-label, prospective, genotype-match controlled for primary estimand, non randomized, multicenter, international Phase 2 clinical trial designed to investigate the efficacy and safety of ER004 administered intraamniotically as a treatment for unborn XLHED male subjects.
What is the current status of trial NCT04980638?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2022-04-26. Estimated completion is 2032-12.
What conditions does trial NCT04980638 study?
This clinical trial studies the following conditions: X-Linked Hypohidrotic Ectodermal Dysplasia (XLHED).
What interventions are being tested in trial NCT04980638?
The interventions under investigation include: ER004 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04980638?
This trial is sponsored by EspeRare Foundation, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04980638 being conducted?
This trial has 8 study locations across California, Missouri, Paris, Bavaria, Saxony. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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