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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: |
NCT02750501 |
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Date of registration:
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20/04/2016 |
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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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Absorption and Safety With Sustained Use of RELiZORB Evaluation (ASSURE) Study
ASSURE |
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Scientific title:
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Absorption and Safety With Sustained Use of RELiZORB Evaluation (ASSURE) Study in Patients With Cystic Fibrosis Receiving Enteral Feeding |
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Date of first enrolment:
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July 20, 2016 |
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Target sample size:
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49 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02750501 |
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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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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Madhumalli Sarkar, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Alcresta Therapeutics, Inc. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Confirmed diagnosis of cystic fibrosis
2. Documented history of exocrine pancreatic insufficiency
3. Enteral formula use a minimum of 4x/week, using PERT, consuming an unrestricted fat
diet, and willing to use Peptamen 1.5 and Impact Peptide 1.5
4. Written informed consent or assent.
Exclusion Criteria:
1. Uncontrolled diabetes mellitus
2. Signs and symptoms of liver cirrhosis or portal hypertension
3. Lung or liver transplant
4. Active cancer currently receiving cancer treatment
5. Crohn's or celiac disease, infectious gastroenteritis, sprue, lactose intolerance,
inflammatory bowel disease
Age minimum:
4 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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Intervention(s)
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Other: Impact Peptide 1.5
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Device: RELiZORB (immobilized lipase) cartridge
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Primary Outcome(s)
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Change From Baseline of Erythrocyte Omega-3 Index % (DHA+EPA)
[Time Frame: Day 0 to Day 90]
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Secondary Outcome(s)
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Erythrocyte Composition (%) of DHA
[Time Frame: RELiZORB Treatment Period (Day 0-Day 90): 90 days]
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Erythrocyte Composition (%) of EPA
[Time Frame: RELiZORB Treatment Period (Day 0-Day 90): 90 days]
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Changes in Plasma Concentration Total DHA+EPA
[Time Frame: RELiZORB Treatment Period (Day 0-Day 90): 90 days]
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Unanticipated Adverse Device Effects (UADE)
[Time Frame: RELiZORB Treatment Period (Day 0-Day 90): 90 days with additional 30 days of follow up.]
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Erythrocyte Composition (%) Ratio of n6/n3 Fatty Acids
[Time Frame: RELiZORB Treatment Period (Day 0-Day 90): 90 days]
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Plasma Composition (%) Ratio of n6/n3 Fatty Acids.
[Time Frame: RELiZORB Treatment Period (Day 0-Day 90): 90 days]
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Secondary ID(s)
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Protocol 0000498-02
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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