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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02598128
Recruitment Status : Completed
First Posted : November 5, 2015
Results First Posted : January 20, 2017
Last Update Posted : January 25, 2017
Sponsor:
Information provided by (Responsible Party):
Alcresta Therapeutics, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Exocrine Pancreatic Insufficiency Device: RELiZORB Device: Placebo Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : November 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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)

  2. 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


Other Outcome Measures:
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   4 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02598128


Locations
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United States, California
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90027
United States, Idaho
St. Luke's Cystic Fibrosis Center of Idaho
Boise, Idaho, United States, 83712
United States, Indiana
Riley Hospital for Children at Indiana University Health
Indianapolis, Indiana, United States, 46202
United States, Maine
Maine Medical Center
Portland, Maine, United States, 04102
United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Cardinal Glennon Children's Medical Center
Saint Louis, Missouri, United States, 63104
United States, Ohio
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States, 44106
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
United States, Pennsylvania
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224
United States, Tennessee
Monroe Carell Junior Children's Hospital at Vanderbilt
Nashville, Tennessee, United States, 37332
United States, Wisconsin
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Alcresta Therapeutics, Inc.
Investigators
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Study Director: Russell G. Clayton, Sr., DO Chief Medical Officer, Alcresta Therapeutics, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Alcresta Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02598128    
Other Study ID Numbers: ALCT-0000497
First Posted: November 5, 2015    Key Record Dates
Results First Posted: January 20, 2017
Last Update Posted: January 25, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Exocrine Pancreatic Insufficiency
Pancreatic Diseases
Digestive System Diseases