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

NCT01992289 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2017-09-05

No results posted yet for this study

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

Conditions

  • X-linked Hypohidrotic Ectodermal Dysplasia

Interventions

DRUG

EDI200

Long-term follow-up study of subjects that received EDI200 as part of protocol ECP-002

Sponsors & Collaborators

  • Edimer Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Kenneth Huttner, MD, PhD · Edimer Pharmaceuticals

Eligibility

Min Age
6 Months
Max Age
1 Year
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2025-03-31
Completion
2025-03-31

Countries

  • United States
  • France
  • Germany
  • Italy
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01992289 on ClinicalTrials.gov