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

Exocrine Pancreatic Insufficiency Clinical Trial

Official title:

Study to Evaluate Safety, Tolerability and Fat Absorption Using a Novel Enteral Feeding In-line Digestive Enzyme Cartridge (RELIZORB) in Patients With Cystic Fibrosis Receiving Enteral Feeding

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02598128
• Other study ID #: ALCT-0000497
• Status: Completed
• Phase: N/A
• First received: November 3, 2015
• Last updated: January 24, 2017
• Start date: November 2015
• Est. completion date: June 2016

Study information

• Verified date: January 2017
• Source: Alcresta Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Exocrine Pancreatic Insufficiency

Intervention

Device:
• RELiZORB
Peptamen 1.5 received Period A and Period B (washout only). Impact Peptide 1.5 received Period B (Days 1 and 9 only) and Period C.
• Placebo
Sham device

Locations

Country	Name	City	State
United States	St. Luke's Cystic Fibrosis Center of Idaho	Boise	Idaho
United States	Rainbow Babies and Children's Hospital	Cleveland	Ohio
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	Riley Hospital for Children at Indiana University Health	Indianapolis	Indiana
United States	Children's Mercy Hospital	Kansas City	Missouri
United States	Children's Hospital of Los Angeles	Los Angeles	California
United States	Children's Hospital of Wisconsin	Milwaukee	Wisconsin
United States	Monroe Carell Junior Children's Hospital at Vanderbilt	Nashville	Tennessee
United States	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania
United States	Maine Medical Center	Portland	Maine
United States	Cardinal Glennon Children's Medical Center	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Alcresta Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Ease of Use of RELiZORB (Per-Protocol Population)	Effect of enteral nutrition on select activities of daily living. Patients judged the size of breakfast after overnight enteral tube feeding with the following choices: No breakfast; Small breakfast; Normal breakfast; Big breakfast; Other.	Period C: Single assessment on Day 19 or 20
Primary	Number of Patients With Adverse Events and Unanticipated Adverse Device Effects	1) Frequency and severity of adverse events; 2) Patients with at least one unanticipated adverse device effects (UADE)	27 days
Primary	Long Chain Polyunsaturated Fatty Acid Plasma Concentration (Intent to Treat Population)	AUC analysis of plasma fatty acid concentration for DHA + EPA baseline adjusted over 24-hours	Day 1 first intervention and Day 9 second intervention.