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

Update Il y a 4 ans
Reference: NCT01992289

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Extract

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


Inclusion criteria

  • X-Linked Hypohidrotic Ectodermal Dysplasia