Safety, Tolerability and Fat Absorption Using Enteral Feeding In-line Enzyme Cartridge (Relizorb)

Not Applicable

Completed

• Conditions: Exocrine Pancreatic Insufficiency
• Interventions: Device: RELiZORB; Device: Placebo

• Registration Number: NCT02598128
• Lead Sponsor: Alcresta Therapeutics, Inc.

Brief Summary

Protocol ALCT-0000497 is a multicenter safety, tolerability and fat absorption study that anticipates enrolling 35 male and female subjects (pediatric and adult) with cystic fibrosis. Subjects with confirmed exocrine pancreatic insufficiency will use a novel enteral feeding in-line digestive enzyme cartridge (RELiZORB) connected to enteral pump sets.

Detailed Description

Protocol ALCT-0000497 consists of three distinct study periods as follows:

1. In Period A (7 days), subjects will receive Peptamen 1.5 enteral feedings at home.

2. In Period B (11 days), subjects will be randomized to either Group A (active investigational then placebo control) or Group B (placebo control then active investigational) and receive Impact Peptide 1.5 on Days 1 and 9. During the 8-day washout period between Days 1 and 9, subjects will receive Peptamen 1.5.

3. In Period C (9 days), subjects will use RELiZORB during nocturnal enteral feedings with Impact Peptide 1.5.

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-03
• Study First Submitted QC: 2015-11-04
• Study First Posted: 2015-11-05
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Results First Submitted: 2016-11-14
• Status Verified: 2017-01
• Results First Submitted QC: 2017-01-19
• Results First Posted: 2017-01-20
• Last Update Submitted: 2017-01-24
• Last Update Posted: 2017-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

1. Confirmed CF diagnosis with 2 clinical features
2. Documented history of EPI
3. Enteral formula use minimum of 4x/week
4. Written informed consent or assent, as applicable

Exclusion Criteria

1. Uncontrolled diabetes mellitus
2. Signs and symptoms of liver cirrhosis or portal hypertension
3. Lung/liver transplant
4. Active cancer currently receiving cancer treatment
5. Crohn's or celiac disease, infectious gastroenteritis, sprue, lactose intolerant, inflammatory bowel disease
6. DIOS or fibrosing colonopathy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
RELiZORB	RELiZORB	Treatment (RELiZORB)
Control	Placebo	Placebo control

Primary Outcome Measures

Name	Time	Method
Long Chain Polyunsaturated Fatty Acid Plasma Concentration (Intent to Treat Population)	Day 1 first intervention and Day 9 second intervention.	AUC analysis of plasma fatty acid concentration for DHA + EPA baseline adjusted over 24-hours
Number of Patients With Adverse Events and Unanticipated Adverse Device Effects	27 days	1) Frequency and severity of adverse events; 2) Patients with at least one unanticipated adverse device effects (UADE)

Trial Locations

Locations (11)

Maine Medical Center; 🇺🇸 Portland, Maine, United States

Rainbow Babies and Children's Hospital; 🇺🇸 Cleveland, Ohio, United States

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States

Monroe Carell Junior Children's Hospital at Vanderbilt; 🇺🇸 Nashville, Tennessee, United States

Children's Hospital of Los Angeles; 🇺🇸 Los Angeles, California, United States

Riley Hospital for Children at Indiana University Health; 🇺🇸 Indianapolis, Indiana, United States

Children's Mercy Hospital; 🇺🇸 Kansas City, Missouri, United States

Cardinal Glennon Children's Medical Center; 🇺🇸 Saint Louis, Missouri, United States

Children's Hospital of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

Children's Hospital of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

St. Luke's Cystic Fibrosis Center of Idaho; 🇺🇸 Boise, Idaho, United States