Absorption and Safety With Sustained Use of RELiZORB Evaluation (ASSURE) Study (ASSURE)
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|ClinicalTrials.gov Identifier: NCT02750501|
Recruitment Status : Completed
First Posted : April 25, 2016
Results First Posted : July 18, 2018
Last Update Posted : August 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis||Device: RELiZORB (immobilized lipase) cartridge Other: Impact Peptide 1.5||Not Applicable|
Study Entry (Day -14): Baseline blood samples collected for plasma and erythrocyte concentrations of docosahexaenoic acid (DHA) and eicosapentaenoic (EPA). Baseline characteristics collected included BMI and cystic fibrosis related diabetes.
Observation Period (Day -14 to Day -8): Subjects followed their usual enteral nutrition regimen with pancreatic enzyme replacement therapy (PERT).
Run-in Period (Day -7 to Day -1): Subjects used Peptamen 1.5 enteral formula at their normal volume of administration from 500 mL to 1,000 mL per feeding with usual PERT regimen.
Treatment Period (Day 0 to Day 90): Subjects used Impact Peptide 1.5 up to a maximum volume of 1,000 mL per feeding with RELiZORB for the 90 day treatment period. Blood screening measurements were repeated at start of treatment period (Day 0), Day 30, Day 60 and Day 90. PERT use with enteral feedings was prohibited. Safety and tolerability were assessed with GI symptom diaries and systematic assessments of adverse events and unanticipated adverse device effects.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Absorption and Safety With Sustained Use of RELiZORB Evaluation (ASSURE) Study in Patients With Cystic Fibrosis Receiving Enteral Feeding|
|Actual Study Start Date :||July 20, 2016|
|Actual Primary Completion Date :||March 30, 2017|
|Actual Study Completion Date :||March 30, 2017|
Single Arm: Open label RELiZORB Cartridge & Impact Peptide 1.5
RELiZORB (immobilized lipase) cartridge and Impact Peptide 1.5 with enteral feedings ranging from 500 mL to 1,000 mL per feeding for a period of 90 days.
Device: RELiZORB (immobilized lipase) cartridge
Hydrolyzing fats from enteral formula, ex vivo, with in-line enteral feed RELiZORB (immobilized lipase) cartridge
Other: Impact Peptide 1.5
Impact Peptide 1.5 at a volume of administration from 500 mL to 1,000 mL per enteral feeding
Other Name: Enteral Formula
- Change From Baseline of Erythrocyte Omega-3 Index % (DHA+EPA) [ Time Frame: Day 0 to Day 90 ]Change from baseline Day 0 to Day 90 of erythrocyte tissue composition % of the omega-3 index
- Unanticipated Adverse Device Effects (UADE) [ Time Frame: RELiZORB Treatment Period (Day 0-Day 90): 90 days with additional 30 days of follow up. ]A UADE is analogous to a serious adverse event (SAE), defined as an AE, occurring at any exposure to the therapeutic agent, that results in any of the following outcomes: death, life-threatening AE, inpatient hospitalization or prolonged existing hospitalization, a persistent or significant disability or incapacity or a congenital anomaly/birth defect.
- Changes in Plasma Concentration Total DHA+EPA [ Time Frame: RELiZORB Treatment Period (Day 0-Day 90): 90 days ]Changes in plasma concentration total DHA+EPA from baseline (Day 0 to Day 90).
- Erythrocyte Composition (%) of DHA [ Time Frame: RELiZORB Treatment Period (Day 0-Day 90): 90 days ]Changes over time in erythrocyte composition (%) for total DHA in ITT population (n=39)
- Erythrocyte Composition (%) of EPA [ Time Frame: RELiZORB Treatment Period (Day 0-Day 90): 90 days ]Changes over time in erythrocyte composition (%) for EPA in ITT population
- Erythrocyte Composition (%) Ratio of n6/n3 Fatty Acids [ Time Frame: RELiZORB Treatment Period (Day 0-Day 90): 90 days ]Change from baseline to Day 90 in n6/n3 ratio in erythrocytes
- Plasma Composition (%) Ratio of n6/n3 Fatty Acids. [ Time Frame: RELiZORB Treatment Period (Day 0-Day 90): 90 days ]Change over time in n6/n3 ratio in plasma in the ITT population
- GI Symptoms [ Time Frame: Observation, Baseline and RELiZORB Treatment periods (Day -14 to Day 90): 104 days with additional 30 days of follow up. ]GI symptoms recorded in GI diaries by subject and/or caregiver.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02750501
|United States, Florida|
|Joe DiMaggio Children's Hospital / Memorial Healthcare System|
|Hollywood, Florida, United States, 33021|
|United States, Idaho|
|St. Luke's CF Center of Idaho|
|Boise, Idaho, United States, 83712|
|United States, Indiana|
|Riley Hospital for Children at Indiana University Health|
|Indianapolis, Indiana, United States, 46202|
|United States, Maine|
|Maine Medical Center|
|Portland, Maine, United States, 04102|
|United States, Michigan|
|Helen DeVos Children's Hospital CF Care Center|
|Grand Rapids, Michigan, United States, 49503|
|United States, Missouri|
|Children's Mercy Hospital|
|Kansas City, Missouri, United States, 64108|
|Cardinal Glennon Children's Hospital / Saint Louis University|
|Saint Louis, Missouri, United States, 63104|
|United States, Ohio|
|Nationwide Children's Hospital|
|Columbus, Ohio, United States, 43205|
|Dayton Children's Hospital|
|Dayton, Ohio, United States, 45404-1815|
|United States, Pennsylvania|
|Children's Hospital of Pittsburgh of UPMC|
|Pittsburgh, Pennsylvania, United States, 15224|
|Study Director:||Madhumalli Sarkar, MD, PhD||Alcresta Therapeutics, Inc.|