Extension Study of XLHED-Affected Male Subjects Treated With EDI200 in Protocol ECP-002
Status:
Active, not recruiting
Trial end date:
2025-03-01
Target enrollment:
Participant gender:
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