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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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21 November 2022 |
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Main ID: |
NCT02635841 |
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Date of registration:
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17/12/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Compassionate Use of Deferiprone in Patients With PKAN
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Scientific title:
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The Compassionate Use of Deferiprone in Patients With Pantothenate Kinase-Associated Neurodegeneration |
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Date of first enrolment:
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June 16, 2016 |
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Target sample size:
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Recruitment status: |
No longer available |
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URL:
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https://clinicaltrials.gov/show/NCT02635841 |
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Study type:
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Expanded Access |
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Study design:
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Phase:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Completed study TIRCON2012V1-EXT
2. Able to adhere to program appointments and evaluation schedules
3. Females of childbearing potential must have a negative pregnancy test result at the
start of the program, unless the treating physician determines there is no reasonable
risk of pregnancy because of significant incapacity. If applicable, they must meet at
least one of the following criteria: Use an effective method of contraception during
the program and for 30 days following the last dose of deferiprone, OR participate in
a non-heterosexual lifestyle, OR have a male sexual partner who has been sterilized,
OR be abstinent during the program and for at least 30 days after its completion.
4. Fertile sexually active heterosexual males must agree to use an effective method of
contraception during the program and for at least 30 days after its completion
5. Patients and/or their authorized legal representatives must provide signed and dated
written informed consent, and minors must additionally sign an assent form as per
local regulatory requirements.
Exclusion Criteria:
Patients will be excluded from taking part in the compassionate use program if the treating
physician determines the presence of any medical, psychological, or psychiatric condition
which in his/her opinion would cause participation in the program to be unwise
Age minimum:
7 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pantothenate Kinase-Associated Neurodegeneration
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Intervention(s)
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Drug: Deferiprone
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Secondary ID(s)
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TIRCON2012V1-COMP
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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