Status:
UNKNOWN
Long Term Follow-up on Menkes Disease Patients
Lead Sponsor:
Cyprium Therapeutics, Inc.
Conditions:
Menkes Disease
Eligibility:
All Genders
Brief Summary
This study will collect long term follow-up data regarding overall survival and neurological parameters from patients previously identified and/or enrolled in Protocols 09-CH-0059 and 90-CH0149 and Hi...
Detailed Description
Primary Objective: 1. To provide additional clinical and safety data on long term following administration of Copper Histidinate treatment in patients treated with Copper Histidinate under Protocols ...
Eligibility Criteria
Inclusion
- The subject must have been previously identified and/or enrolled under Protocols 09-CH-0059 or 90-CH-0149; or An untreated Menkes disease patients for whom data collection is incomplete under Protocols 09-CH-0059 (Amendment M); or Other untreated Menkes disease patients.
- Must sign and date an informed consent form by parent or legal guardian for this study prior to any assessment being done in this study. If the patient is \> 18 years of age, the patient must sign the informed consent.
- Male or female, aged 0 to \< 65 years of age.
Exclusion
- \- Unwillingness/unable to participate in the study.
Key Trial Info
Start Date :
December 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04337684
Start Date
December 1 2019
End Date
December 31 2023
Last Update
September 28 2023
Active Locations (1)
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1
Cyprium Study Team
New York, New York, United States, 10014