Absorption and Safety With Sustained Use of RELiZORB Evaluation (ASSURE) Study

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-20

Study Completion Date

2017-03-30

Brief Summary

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Protocol 0000498: Multicenter, open label study to evaluate the effect of sustained RELiZORB (immobilized lipase) cartridge use during enteral feeding on fat absorption, as well as safety and tolerability of sustained RELiZORB use, in patients with cystic fibrosis and exocrine pancreatic insufficiency.

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Detailed Description

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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.

Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

RELiZORB (immobilized lipase) cartridge

Intervention Type DEVICE

Hydrolyzing fats from enteral formula, ex vivo, with in-line enteral feed RELiZORB (immobilized lipase) cartridge

Impact Peptide 1.5

Intervention Type OTHER

Impact Peptide 1.5 at a volume of administration from 500 mL to 1,000 mL per enteral feeding

Interventions

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RELiZORB (immobilized lipase) cartridge

Hydrolyzing fats from enteral formula, ex vivo, with in-line enteral feed RELiZORB (immobilized lipase) cartridge

Intervention Type DEVICE

Impact Peptide 1.5

Impact Peptide 1.5 at a volume of administration from 500 mL to 1,000 mL per enteral feeding

Intervention Type OTHER

Other Intervention Names

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Enteral Formula

Eligibility 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

Minimum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No