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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: |
NCT02279498 |
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Date of registration:
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28/10/2014 |
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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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SOLUTION: Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin in Patients With Cystic Fibrosis
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Scientific title:
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A Phase 3, Randomized, Open-Label, Assessor-Blind, Noninferiority, Active-Comparator 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 2015 |
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Target sample size:
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128 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02279498 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel 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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Canada
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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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Contacts
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Name:
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Monica Gangal |
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Address:
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Telephone:
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Email:
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Affiliation:
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Anthera Pharmaceuticals |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of Cystic Fibrosis based on presentation, genotype and/or sweat chloride
- Fecal elastase <100 mcg/g stool
- Minimum Coefficient of Fat (CFA) at screening while on stable PERT therapy
- 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
- Forced expiratory volume in 1 second (FEV1) <30%
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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Drug: porcine (pig) PERT
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Primary Outcome(s)
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Treatment Difference in Coefficient of Fat Absorption (CFA) Change From Baseline
[Time Frame: Baseline, 7 weeks]
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Secondary Outcome(s)
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Coefficient of Fat Absorption (CFA)
[Time Frame: Baseline, 7 weeks]
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Coefficient of Nitrogen Absorption (CNA)
[Time Frame: Baseline, 7 weeks]
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Secondary ID(s)
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AN-EPI3331
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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