Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Brief Summary
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Detailed Description
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Conditions
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Interventions
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copper histidinate
copper histidinate for subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Parent or legal guardian is willing and able to sign and date an informed consent form.
3. Male or female, aged 0 to \<6 years of age.
4. Diagnosis of Menkes disease: A confirmed gene mutation in ATP7A is not required; however, the test must be at least pending prior to initiating therapy. For those patients whose molecular ATP7A gene mutation confirmation is pending, they should have serum copper \<75 mcg/dL. If the mutation is subsequently not confirmed, the patient should discontinue treatment.
5. Ability to adhere to the prescribed subcutaneous copper histidinate injection regimen.
6. Willingness to adhere to all recommended visits and procedures.
7. Resident of the US.
Exclusion Criteria
2. Any disease or condition that, in the opinion of the Investigator, has a high probability of precluding the subject from completing the study or where the subject cannot or will not appropriately comply with study requirements.
3. Receipt of concomitant medication or device not approved for any use (i.e. experimental) by FDA within 30 days prior to screening for this study, except for participation in protocol 09-CH-0059.
4. Patient/caregiver cannot or will not appropriately comply with protocol recommendations (e.g., site visits, renal monitoring).
5. Currently receiving any concomitant copper-containing medications.
0 Years
6 Years
ALL
No
Sponsors
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Sentynl Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Phoenix Children's Hospital
Phoenix, Arizona, United States
University of California Davis Medical Center
Sacramento, California, United States
Rady Children's Hospital
San Diego, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Connecticut Children's Medical Center
Hartford, Connecticut, United States
Memorial Healthcare Systems
Hollywood, Florida, United States
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, United States
Emory University
Atlanta, Georgia, United States
Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
University of Iowa Stead Family Children's Hospital
Iowa City, Iowa, United States
Maine Medical Center
Portland, Maine, United States
Helen DeVos Children's Hospital
Grand Rapids, Michigan, United States
Shodair Children's Hospital
Helena, Montana, United States
Duke University Hospital
Durham, North Carolina, United States
Oregon Health & Science University
Portland, Oregon, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Monroe Carrell Jr. Children's Hospital at Vanderbilt University Medical Center
Nashville, Tennessee, United States
Cook Children's Health Care System
Fort Worth, Texas, United States
Seattle Children's Hospital
Seattle, Washington, United States
Countries
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Central Contacts
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Related Links
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Related Info
Other Identifiers
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CYP-001
Identifier Type: -
Identifier Source: org_study_id