Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Exocrine Pancreatic Insufficiency
Interventions Device: RELiZORB
Device: Placebo
Enrollment 34
Recruitment Details 34 patients enrolled; 33 patients completed the study from 11 U.S. sites.
Pre-assignment Details 33 eligible patients according to the inclusion/exclusion criteria were randomized in Period B (double-blind crossover) to the study.
Arm/Group Title Period A: Clinical Treatment Practice (Days -7 to -1) Crossover Period B: Placebo Then RELiZORB Crossover Period B: RELiZORB Then Placebo Period C: Clinical Treatment Practice + RELiZORB (Days 12-20)
Hide Arm/Group Description Period A was a 7-day baseline period. Patients received Peptamen 1.5 at their normal volume of enteral formula administration up to a maximum of 1000 mL per feeding. Current treatment practice was followed with normal use of oral pancreatic enzyme replacement therapy (PERT) during daily meals and nightly enteral feedings. A gastrointestinal symptom diary was completed for 7 consecutive days. Baseline Day -7 required a clinic visit followed by Days -6 to -1 at home. Eligible subjects were randomized to Placebo then RELiZORB. Eligible subjects were randomized to RELiZORB then Placebo. Period C was the open label clinical treatment period with RELiZORB. All patients used RELiZORB with Impact Peptide 1.5 at their normal volume as in Period A up to a maximum of 1000 mL per feeding. Patients were instructed to use the same daily dose and schedule of oral PERT taken in Period C as in Period A. There were no dietary restrictions. A gastrointestinal symptom diary was completed for 7 consecutive days. Patients received enteral feeding at home from Days 12 to 18 and returned to clinic for their end of study Day 19.
Period Title: Period A: Days -7 to -1
Started 34 0 0 0
Completed 33 0 0 0
Not Completed 1 0 0 0
Reason Not Completed
Adverse Event             1             0             0             0
Period Title: Period B: Days 1 to 11
Started 0 17 16 0
Completed 0 17 16 0
Not Completed 0 0 0 0
Period Title: Period C: Days 12 to 20
Started 0 0 0 33
Completed 0 0 0 33
Not Completed 0 0 0 0
Arm/Group Title Clinical Treatment Practice: Period A: Days -7 to -1
Hide Arm/Group Description Period A was a 7-day baseline period. Patients received Peptamen 1.5 at their normal volume of enteral formula administration up to a maximum of 1000 mL per feeding. Current treatment practice was followed with normal use of oral pancreatic enzyme replacement therapy (PERT) during daily meals and nightly enteral feedings. A gastrointestinal symptom diary was completed for 7 consecutive days. Baseline Day -7 required a clinic visit followed by Days -6 to -1 at home.
Overall Number of Baseline Participants 33
Hide Baseline Analysis Population Description
Safety Population
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
<=18 years
27
  81.8%
Between 18 and 65 years
6
  18.2%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
Female
13
  39.4%
Male
20
  60.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
Hispanic or Latino
5
  15.2%
Not Hispanic or Latino
28
  84.8%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   3.0%
White
31
  93.9%
More than one race
0
   0.0%
Unknown or Not Reported
1
   3.0%
Region of Enrollment   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 33 participants
33
 100.0%
[1]
Measure Description: 11 United States clinical sites.
Baseline Weight   [1] 
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 33 participants
41.81  (13.332)
[1]
Measure Analysis Population Description: Baseline weight obtained in Period A.
Baseline Height   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 33 participants
152.32  (19.640)
[1]
Measure Description: Safety Population: Baseline Height
[2]
Measure Analysis Population Description: Baseline height obtained in Period A.
Baseline Body Mass Index   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 33 participants
17.47  (2.026)
[1]
Measure Analysis Population Description: Baseline Body Mass Index obtained in Period A.
1.Primary Outcome
Title Number of Patients With Adverse Events and Unanticipated Adverse Device Effects
Hide Description 1) Frequency and severity of adverse events; 2) Patients with at least one unanticipated adverse device effects (UADE)
Time Frame 27 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Clinical Treatment Practice: Period A: Days -7 to -1 Crossover Period B: Placebo Crossover Period B: RELiZORB Clinical Treatment Practice + RELiZORB: Period C: Days 12-20
Hide Arm/Group Description:
Period A was a 7-day baseline period. Patients received Peptamen 1.5 at their normal volume of enteral formula administration up to a maximum of 1000 mL per feeding. Current treatment practice was followed with normal use of oral pancreatic enzyme replacement therapy (PERT) during daily meals and nightly enteral feedings. A gastrointestinal symptom diary was completed for 7 consecutive days. Baseline Day -7 required a clinic visit followed by Days -6 to -1 at home.
Non-gastrointestinal adverse events during administration.
Non-gastrointestinal adverse events during administration.
Non-gastrointestinal adverse events during CTP+RELiZORB administration.
Overall Number of Participants Analyzed 33 33 33 33
Measure Type: Count of Participants
Unit of Measure: Participants
Patients With Adverse Events
4
  12.1%
6
  18.2%
1
   3.0%
2
   6.1%
Adverse Event by Severity (Mild)
2
   6.1%
6
  18.2%
1
   3.0%
0
   0.0%
Adverse Event by Severity (Moderate)
2
   6.1%
0
   0.0%
0
   0.0%
1
   3.0%
Adverse Event by Severity (Severe)
0
   0.0%
0
   0.0%
0
   0.0%
1
   3.0%
Patients With At Least One UADE
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2.Primary Outcome
Title Long Chain Polyunsaturated Fatty Acid Plasma Concentration (Intent to Treat Population)
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RELiZORB Control
Hide Arm/Group Description:
Subjects receiving RELiZORB at any time in the study.
Subjects receiving placebo at any time in the study.
Overall Number of Participants Analyzed 33 33
Mean (Standard Deviation)
Unit of Measure: ug*h/mL
536.98  (400.519) 192.18  (198.664)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RELiZORB, Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments The independent variables in the mixed model analysis included fixed effect factors for treatment (placebo or RELiZORB).
3.Other Pre-specified Outcome
Title Ease of Use of RELiZORB (Per-Protocol Population)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population.
Arm/Group Title Clinical Treatment Practice and Relizorb: Period C: Days 12-20
Hide Arm/Group Description:
Period C was the open label clinical treatment period with RELiZORB. All patients received RELiZORB with Impact Peptide 1.5 at their normal volume as in Period A up to a maximum of 1000 mL per feeding. Patients were instructed to use the same daily dose and schedule of oral PERT taken in Period C as in Period A. There were no dietary restrictions. A gastrointestinal symptom diary was completed for 7 consecutive days. Patients received enteral feeding at home from Days 12 to 18 and returned to clinic for their end of study Day 19.
Overall Number of Participants Analyzed 32
Measure Type: Count of Participants
Unit of Measure: Participants
No breakfast
11
  34.4%
Small breakfast
14
  43.8%
Normal breakfast
6
  18.8%
Big breakfast
0
   0.0%
Other
1
   3.1%
Time Frame 20 days
Adverse Event Reporting Description Safety Population: Non-gastrointestinal Adverse Event by System Organ Class and Preferred Term (n=33)
 
Arm/Group Title Clinical Treatment Practice: Period A: Days -7 to -1 Double-Blind Crossover: Period B: Days 1 to 11 Clinical Treatment Practice and Relizorb: Period C: Days 12-20
Hide Arm/Group Description Period A was a 7-day baseline period. Patients received Peptamen 1.5 at their normal volume of enteral formula administration up to a maximum of 1000 mL per feeding. Current treatment practice was followed with normal use of oral pancreatic enzyme replacement therapy (PERT) during daily meals and nightly enteral feedings. A gastrointestinal symptom diary was completed for 7 consecutive days. Baseline Day -7 required a clinic visit followed by Days -6 to -1 at home. Period B was the randomized, double-blind, placebo-controlled crossover period. Eligible patients were randomized in a 1:1 ratio to either Placebo-RELiZORB or RELiZORB-Placebo treatment sequences. On two separate administration Days 1 and 9, patients received 500 mL of Impact Peptide1.5 in clinic over a 4h period. Motility and acid suppression medications were discontinued 24h before arrival in clinic. No nocturnal feeding occurred between Days 1-2 and Days 9-10. During the home washout period Days 2 to 8, patients received Peptamen 1.5 for enteral nutrition up to a maximum volume of 1000 mL per feeding. Safety follow up calls were conducted on Days 2 and 10. Period C was the open label clinical treatment period with RELiZORB. All patients received RELiZORB with Impact Peptide 1.5 at their normal volume as in Period A up to a maximum of 1000 mL per feeding. Patients were instructed to use the same daily dose and schedule of oral PERT taken in Period C as in Period A. There were no dietary restrictions. A gastrointestinal symptom diary was completed for 7 consecutive days. Patients received enteral feeding at home from Days 12 to 18 and returned to clinic for their end of study Day 19.
All-Cause Mortality
Clinical Treatment Practice: Period A: Days -7 to -1 Double-Blind Crossover: Period B: Days 1 to 11 Clinical Treatment Practice and Relizorb: Period C: Days 12-20
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Clinical Treatment Practice: Period A: Days -7 to -1 Double-Blind Crossover: Period B: Days 1 to 11 Clinical Treatment Practice and Relizorb: Period C: Days 12-20
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/33 (3.03%)      0/33 (0.00%)      0/33 (0.00%)    
Infections and infestations       
Cystic fibrosis pulmonary exacerbation  1 [1]  1/33 (3.03%)  1 0/33 (0.00%)  0 0/33 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
[1]
Cystic fibrosis (increased cough, vomiting, decreased PFTs, hospital care required supplemental oxygen, IV antibiotics, and supportive care).
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Clinical Treatment Practice: Period A: Days -7 to -1 Double-Blind Crossover: Period B: Days 1 to 11 Clinical Treatment Practice and Relizorb: Period C: Days 12-20
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/33 (6.06%)      0/33 (0.00%)      0/33 (0.00%)    
Nervous system disorders       
Headache  1  2/33 (6.06%)  3 0/33 (0.00%)  0 0/33 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Russell G. Clayton, D.O., Chief Medical Officer
Organization: Alcresta Therapeutics, Inc.
Phone: 215.813.5100
EMail: rclayton@alcresta.com
Layout table for additonal information
Responsible Party: Alcresta Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02598128     History of Changes
Other Study ID Numbers: ALCT-0000497
First Submitted: November 3, 2015
First Posted: November 5, 2015
Results First Submitted: November 14, 2016
Results First Posted: January 20, 2017
Last Update Posted: January 25, 2017