UnknownNot Applicable

Extension Study of XLHED-Affected Male Subjects Treated With EDI200 in Protocol ECP-002

United States, France, Germany10 participantsStarted 2014-03

Plain-language summary

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

Who can participate

Age range6 Months – 1 Year

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Subject received at least one dose of EDI200 in the neonate study ECP-002
✓. Written informed consent of parent(s)

Exclusion criteria

✕. 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

What they're measuring

Growth and development

Timeframe: Annually up to age 10 years

Dentition

Timeframe: Change from baseline dentition at 2, 5 and 10 years

Trial details

NCT IDNCT01992289

SponsorEdimer Pharmaceuticals

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-03

View on ClinicalTrials.gov More X-linked Hypohidrotic Ectodermal Dysplasia trials