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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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12 December 2020 |
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Main ID: |
NCT02993133 |
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Date of registration:
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12/12/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Pharmacokinetics Study of Mycophenolic Acid in Patients With an Autoimmune Bullous Dermatose, Pemphigus or Cicatricial Pemphigoid.
PEMPA |
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Scientific title:
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Pharmacokinetics Study of Mycophenolic Acid in Patients With an Autoimmune Bullous Dermatose, Pemphigus or Cicatricial Pemphigoid. |
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Date of first enrolment:
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December 2016 |
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Target sample size:
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53 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02993133 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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France
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age > or = 18 years.
- Patient treated by Mycophénolate Mofétil (MMF) per os (Cellcept®) for an autoimmune
bullous dermatose (pemphigus or cicatricial pemphigoid) for at least 30 days according
to the recommendations (PNDS Pemphigus and cicatricial pemphigoid HAS 2011)
- Patient able to understand the nature, purpose and methodology of the study
- Patient affiliated to the French social security system or equivalent
- Patient who have signed an informed consent form
Exclusion Criteria:
- Pregnant or breast-feeding women or women of childbearing potential without efficient
contraception (based on a declaration)
- Patient under legal protection.
- Patient deprived of freedom
- Patient with any altered mental status or any psychiatric condition that would
interfere with the understanding of the study.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Autoimmune Bullous Dermatose
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Intervention(s)
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Drug: Cellcept® in autoimmune bullous dermatoses
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Primary Outcome(s)
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Evaluation of the Bayesian estimator performance
[Time Frame: 8 hours]
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Secondary ID(s)
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I14027 / PEMPA
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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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