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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: |
NCT02734810 |
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Date of registration:
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06/04/2016 |
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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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SIMPLICITY: Studying Impacts on Malabsorption With Liprotamase in Cystic Fibrosis
SIMPLICITY |
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Scientific title:
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A Phase 3, Open-Label Study Evaluating the Efficacy and Safety of Liprotamase in Subjects With Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency |
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Date of first enrolment:
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June 2016 |
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Target sample size:
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15 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02734810 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. 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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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- For Part A: males or females =7 years of age
- For Part B: males or females 28 days to <7 years
- Diagnosis of cystic fibrosis based on presentation, genotype and/or sweat chloride
- Low fecal elastase
- Fair-to-good nutritional status
Exclusion Criteria:
- History or diagnosis of fibrosing colonopathy
- Distal intestinal obstruction syndrome in 6 months prior to screening
- Receiving enteral tube feedings
- Chronic diarrheal illness unrelated to pancreatic insufficiency
- Liver abnormalities, or liver or lung transplant, or significant bowel resection
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis
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Exocrine Pancreatic Insufficiency
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Intervention(s)
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Drug: Liprotamase Powder for Oral Solution
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Primary Outcome(s)
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Safety
[Time Frame: 1 week]
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Secondary ID(s)
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AN-EPI3332
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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