CompletedNot Applicable

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

United States49 participantsStarted 2016-07-20

Plain-language summary

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.

Who can participate

Age range4 Years

SexALL

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Inclusion criteria

✓. Confirmed diagnosis of cystic fibrosis
✓. Documented history of exocrine pancreatic insufficiency
✓. 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
✓. Written informed consent or assent.

Exclusion criteria

✕. Uncontrolled diabetes mellitus
✕. Signs and symptoms of liver cirrhosis or portal hypertension
✕. Lung or liver transplant
✕. Active cancer currently receiving cancer treatment
✕. Crohn's or celiac disease, infectious gastroenteritis, sprue, lactose intolerance, inflammatory bowel disease

What they're measuring

Change From Baseline of Erythrocyte Omega-3 Index % (DHA+EPA)

Timeframe: Day 0 to Day 90

Trial details

NCT IDNCT02750501

SponsorAlcresta Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-03-30

Results submitted2018-03-30

View on ClinicalTrials.gov More Cystic Fibrosis trials