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Intraamniotic Administrations of ER004 to Male Subjects With X-linked Hypohidrotic Ectodermal Dysplasia
Sponsor: EspeRare Foundation
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.
Official title: A Prospective, Open-label, Genotype-match Controlled, Multicenter Clinical Trial to Investigate the Efficacy and Safety of Intra-amniotic ER004 as a Prenatal Treatment for Male Subjects With XLHED
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2022-04-26
Completion Date
2032-12
Last Updated
2025-04-30
Healthy Volunteers
No
Interventions
ER004
Intra-amniotic route 100 mg/kg of estimated fetal weight per injection. 3 injections, approximately 3 weeks apart starting from gestational week 26
Locations (8)
Cedars-Sinai Medical Center
Los Angeles, California, United States
Washington University
St Louis, Missouri, United States
Hôpital Necker - Enfants Malades
Paris, Paris, France
Universitaetsklinikum Erlangen
Erlangen, Bavaria, Germany
Universitaetsklinikum Leipzig AoeR
Leipzig, Saxony, Germany
IRCCS Ca' Granda Ospedale Policlinico
Milan, Italy
Hospital Universitario Virgen de la Arrixaca
El Palmar, Murcia, Spain
University Hospital of Wales Cardiff and Vale University Local Health
Cardiff, United Kingdom