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

NCT02750501 | Completed Results DMC FDA Device

• 1 other identifier: Protocol 0000498-02
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Cystic Fibrosis

Keywords

CF, EPI, diabetes, PERT, LCPUFA, DHA, EPA, Omega-3 index

Outcome Measures

Primary Outcomes (1)

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

  Change from baseline Day 0 to Day 90 of erythrocyte tissue composition % of the omega-3 index

  Day 0 to Day 90

Secondary Outcomes (6)

• Unanticipated Adverse Device Effects (UADE)

  RELiZORB Treatment Period (Day 0-Day 90): 90 days with additional 30 days of follow up.

• Changes in Plasma Concentration Total DHA+EPA

  RELiZORB Treatment Period (Day 0-Day 90): 90 days

• Erythrocyte Composition (%) of DHA

  RELiZORB Treatment Period (Day 0-Day 90): 90 days

• Erythrocyte Composition (%) of EPA

  RELiZORB Treatment Period (Day 0-Day 90): 90 days

• Erythrocyte Composition (%) Ratio of n6/n3 Fatty Acids

  RELiZORB Treatment Period (Day 0-Day 90): 90 days

Other Outcomes (1)

• GI Symptoms

  Observation, Baseline and RELiZORB Treatment periods (Day -14 to Day 90): 104 days with additional 30 days of follow up.

Study Arms (1)

Single Arm: Open label RELiZORB Cartridge & Impact Peptide 1.5

OTHER

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; Other: Impact Peptide 1.5

Interventions

RELiZORB (immobilized lipase) cartridge DEVICE

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

Single Arm: Open label RELiZORB Cartridge & Impact Peptide 1.5

Impact Peptide 1.5 OTHER

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

Also known as: Enteral Formula

Single Arm: Open label RELiZORB Cartridge & Impact Peptide 1.5

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Alcresta Therapeutics, Inc.: lead
• Cystic Fibrosis Foundation: collaborator

Study Sites (10)

Joe DiMaggio Children's Hospital / Memorial Healthcare System

Hollywood, Florida, 33021, United States

Location

St. Luke's CF Center of Idaho

Boise, Idaho, 83712, United States

Location

Riley Hospital for Children at Indiana University Health

Indianapolis, Indiana, 46202, United States

Location

Maine Medical Center

Portland, Maine, 04102, United States

Location

Helen DeVos Children's Hospital CF Care Center

Grand Rapids, Michigan, 49503, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Cardinal Glennon Children's Hospital / Saint Louis University

St Louis, Missouri, 63104, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Dayton Children's Hospital

Dayton, Ohio, 45404-1815, United States

Location

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis; Exocrine Pancreatic Insufficiency; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

Patient GI symptom diary: recall method using unvalidated tool. Patients were allowed to eat normal diet during the day, hence the amount of LCPUFA that was measured in the plasma is not the sole reflection of the device use only.

Results Point of Contact

• Title: Madhumalli ("Molly") Sarkar, MD, PhD, Head of Clinical Development
• Organization: Alcresta Therapeutics, Inc.

msarkar@alcresta.com

617 431 8866

Study Officials

• Madhumalli Sarkar, MD, PhD

  Alcresta Therapeutics, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2016
• First Posted: April 25, 2016
• Study Start: July 20, 2016
• Primary Completion: March 30, 2017
• Study Completion: March 30, 2017
• Last Updated: August 15, 2018
• Results First Posted: July 18, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)