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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: |
NCT02823964 |
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Date of registration:
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29/06/2016 |
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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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EASY: Extended Access to Sollpura Over Years
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Scientific title:
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An Open-Label Study Evaluating the Efficacy and Safety of Liprotamase in Subjects With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis |
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Date of first enrolment:
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September 2016 |
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Target sample size:
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25 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02823964 |
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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 4
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Countries of recruitment
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Czech Republic
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Czechia
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Hungary
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Israel
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Poland
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Spain
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Male or female subjects with cystic fibrosis-related exocrine pancreatic insufficiency
who received liprotamase and completed Study AN-EPI3331 (SOLUTION: Study of Oral
Liprotamase Unit-Matched Therapy Of Non-Porcine Origin in Patients With Cystic
Fibrosis)
Exclusion Criteria:
- Any medical, psychological, or social condition that may put the subject at increased
risk by participating in this study.
- Females who are nursing, pregnant, intending to become pregnant, or intending to nurse
during the time of the study.
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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Cystic Fibrosis
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Exocrine Pancreatic Insufficiency
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Intervention(s)
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Drug: Liprotamase
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Primary Outcome(s)
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Safety, as Measured by Number of Participants With Adverse Events Including Clinical or Laboratory Abnormalities
[Time Frame: 12 months]
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Secondary ID(s)
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AN-EPI3334
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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