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

January 24, 2017 updated by: Alcresta Therapeutics, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90027
        • Children's Hospital of Los Angeles
    • Idaho
      • Boise, Idaho, United States, 83712
        • St. Luke's Cystic Fibrosis Center of Idaho
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Riley Hospital for Children at Indiana University Health
    • Maine
      • Portland, Maine, United States, 04102
        • Maine Medical Center
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Children's Mercy Hospital
      • Saint Louis, Missouri, United States, 63104
        • Cardinal Glennon Children's Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Rainbow Babies and Children's Hospital
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
        • Children's Hospital of Pittsburgh
    • Tennessee
      • Nashville, Tennessee, United States, 37332
        • Monroe Carell Junior Children's Hospital at Vanderbilt
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Children's Hospital of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 45 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: RELiZORB
Treatment (RELiZORB)
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.
Other Names:
  • Peptamen 1.5
  • Impact Peptide 1.5
PLACEBO_COMPARATOR: Control
Placebo control
Device: Placebo
Sham device

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ease of Use of RELiZORB (Per-Protocol Population)
Time Frame: Period C: Single assessment on Day 19 or 20
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcresta Therapeutics, Inc.

Investigators

  • Study Director: Russell G. Clayton, Sr., DO, Chief Medical Officer, Alcresta Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (ACTUAL)

June 1, 2016

Study Completion (ACTUAL)

June 1, 2016

Study Registration Dates

First Submitted

November 3, 2015

First Submitted That Met QC Criteria

November 4, 2015

First Posted (ESTIMATE)

November 5, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

January 25, 2017

Last Update Submitted That Met QC Criteria

January 24, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALCT-0000497

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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