Extension Study of XLHED-Affected Male Subjects Treated With EDI200 in Protocol ECP-002
Status unconfirmed
Conditions studied: X-linked Hypohidrotic Ectodermal Dysplasia
In brief
The goal of the ECP-002e extension study is to continue the evaluation of all EDI200-treated ECP-002 subjects up to age 10 yrs. No additional study drug administration is planned. The efficacy evaluations will incorporate growth and development parameters, frequency of infections and hospitalizations, and age-appropriate assessments of ectoderm-derived organ function. The safety evaluations will include physical examinations, adverse events and concomitant medication documentation, and laboratory testing. Funding Source - FDA OOPD
Key facts
- Study ID
- NCT01992289
- Run by
- Edimer Pharmaceuticals
- People needed
- 10
- Starts
- 2014-03-01
- Expected to finish
- 2025-03-01
- Last updated by the study team
- 2017-09-05
Who can join
Age: 1 and older, up to 1. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Subjects must meet all of the following criteria to be enrolled:
- Subject received at least one dose of EDI200 in the neonate study ECP-002
- Written informed consent of parent(s)
You may not qualify if…
- Subjects who meet any of the following criteria may not be enrolled in this study:
- Medically-significant postnatal complications or congenital anomalies outside of those considered to be associated with the diagnosis of XLHED
- Major protocol violations during enrollment in study ECP-002 as determined by the Sponsor
Where it is running
- University of California, San Francisco — San Francisco, California, United States
- Children's National Medical Center — Washington D.C., District of Columbia, United States
- Washington University School of Medicine — St Louis, Missouri, United States
- Hôpital Necker-Enfants Malades — Paris, France
- Universitätsklinikum Erlangen — Erlangen, Bavaria, Germany
- Azienda Ospedaliera-Polo Universitario "Luigi Sacco" — Milan, Italy
- University Hospital of Wales — Cardiff, United Kingdom
Full record on ClinicalTrials.gov
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