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

Completed · Not applicable

Conditions studied: Cystic Fibrosis

In brief

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.

Key facts

Study ID

NCT02750501

Run by

Alcresta Therapeutics, Inc.

People needed

49

Starts

2016-07-20

Expected to finish

2017-03-30

Last updated by the study team

2018-08-15

Who can join

Age: 4 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Joe DiMaggio Children's Hospital / Memorial Healthcare System — Hollywood, Florida, United States
• St. Luke's CF Center of Idaho — Boise, Idaho, United States
• Riley Hospital for Children at Indiana University Health — Indianapolis, Indiana, United States
• Maine Medical Center — Portland, Maine, United States
• Helen DeVos Children's Hospital CF Care Center — Grand Rapids, Michigan, United States
• Children's Mercy Hospital — Kansas City, Missouri, United States
• Cardinal Glennon Children's Hospital / Saint Louis University — St Louis, Missouri, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• Dayton Children's Hospital — Dayton, Ohio, United States
• Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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