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RECRUITING
NCT04980638
PHASE2

Intraamniotic Administrations of ER004 to Male Subjects With X-linked Hypohidrotic Ectodermal Dysplasia

Sponsor: EspeRare Foundation

View on ClinicalTrials.gov

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

BIOLOGICAL

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