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

Primary Purpose

Exocrine Pancreatic Insufficiency

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RELiZORB
Placebo
Sponsored by
Alcresta Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Exocrine Pancreatic Insufficiency

Eligibility Criteria

4 Years - 45 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Hospital of Los Angeles
  • St. Luke's Cystic Fibrosis Center of Idaho
  • Riley Hospital for Children at Indiana University Health
  • Maine Medical Center
  • Children's Mercy Hospital
  • Cardinal Glennon Children's Medical Center
  • Rainbow Babies and Children's Hospital
  • Nationwide Children's Hospital
  • Children's Hospital of Pittsburgh
  • Monroe Carell Junior Children's Hospital at Vanderbilt
  • Children's Hospital of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

RELiZORB

Control

Arm Description

Treatment (RELiZORB)

Placebo control

Outcomes

Primary Outcome Measures

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)
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

Secondary Outcome Measures

Full Information

First Posted
November 3, 2015
Last Updated
January 24, 2017
Sponsor
Alcresta Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02598128
Brief Title
Safety, Tolerability and Fat Absorption Using Enteral Feeding In-line Enzyme Cartridge (Relizorb)
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcresta Therapeutics, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: In Period A (7 days), subjects will receive Peptamen 1.5 enteral feedings at home. 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. In Period C (9 days), subjects will use RELiZORB during nocturnal enteral feedings with Impact Peptide 1.5.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exocrine Pancreatic Insufficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RELiZORB
Arm Type
Experimental
Arm Description
Treatment (RELiZORB)
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Placebo control
Intervention Type
Device
Intervention Name(s)
RELiZORB
Other Intervention Name(s)
Peptamen 1.5, Impact Peptide 1.5
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Placebo
Intervention Description
Sham device
Primary Outcome Measure Information:
Title
Number of Patients With Adverse Events and Unanticipated Adverse Device Effects
Description
1) Frequency and severity of adverse events; 2) Patients with at least one unanticipated adverse device effects (UADE)
Time Frame
27 days
Title
Long Chain Polyunsaturated Fatty Acid Plasma Concentration (Intent to Treat Population)
Description
AUC analysis of plasma fatty acid concentration for DHA + EPA baseline adjusted over 24-hours
Time Frame
Day 1 first intervention and Day 9 second intervention.
Other Pre-specified Outcome Measures:
Title
Ease of Use of RELiZORB (Per-Protocol Population)
Description
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.
Time Frame
Period C: Single assessment on Day 19 or 20

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Confirmed CF diagnosis with 2 clinical features Documented history of EPI Enteral formula use minimum of 4x/week Written informed consent or assent, as applicable Exclusion Criteria: Uncontrolled diabetes mellitus Signs and symptoms of liver cirrhosis or portal hypertension Lung/liver transplant Active cancer currently receiving cancer treatment Crohn's or celiac disease, infectious gastroenteritis, sprue, lactose intolerant, inflammatory bowel disease DIOS or fibrosing colonopathy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Russell G. Clayton, Sr., DO
Organizational Affiliation
Chief Medical Officer, Alcresta Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Children's Hospital of Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
St. Luke's Cystic Fibrosis Center of Idaho
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
Riley Hospital for Children at Indiana University Health
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Maine Medical Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Cardinal Glennon Children's Medical Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Rainbow Babies and Children's Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Monroe Carell Junior Children's Hospital at Vanderbilt
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37332
Country
United States
Facility Name
Children's Hospital of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28471913
Citation
Freedman S, Orenstein D, Black P, Brown P, McCoy K, Stevens J, Grujic D, Clayton R. Increased Fat Absorption From Enteral Formula Through an In-line Digestive Cartridge in Patients With Cystic Fibrosis. J Pediatr Gastroenterol Nutr. 2017 Jul;65(1):97-101. doi: 10.1097/MPG.0000000000001617.
Results Reference
derived

Learn more about this trial

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

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