CompletedNCT02598128Updated Jan 25, 2017Results posted

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

An interventional study of RELiZORB and Placebo in Exocrine Pancreatic Insufficiency, sponsored by Alcresta Therapeutics, Inc.. Completed at 11 sites in United States. Open to participants aged 4 Years to 45 Years. Per ClinicalTrials.gov, last updated 2017-01-25.

Sponsored by Alcresta Therapeutics, Inc. · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 34
Allocation: Randomized
Ages: 4 Years to 45 Years
Sex: All

Study 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.

Read the 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.

Conditions studied

Exocrine Pancreatic Insufficiency

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Exocrine Pancreatic Insufficiency 128

In context

Exocrine Pancreatic Insufficiency

128 studies on the registry are indexed under Exocrine Pancreatic Insufficiency; 27 are open to participants now.

This study's enrollment of 34 is below the median of 40 across 90 interventional studies indexed under Exocrine Pancreatic Insufficiency.

Browse Exocrine Pancreatic Insufficiency studies →

Lead sponsor

Alcresta Therapeutics, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 4 Years to 45 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 34 participants (actual)

Study arms

Experimental
RELiZORB
Treatment (RELiZORB)
Device: RELiZORB
Placebo comparator
Control
Placebo control
Device: Placebo

Interventions

DeviceRELiZORB
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.
Also known as: Peptamen 1.5, Impact Peptide 1.5
DevicePlacebo
Sham device

What researchers measure

Primary outcomes

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)
Time frame: 27 days
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
Time frame: Day 1 first intervention and Day 9 second intervention.

Other outcomes

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.
Time frame: Period C: Single assessment on Day 19 or 20

Results

Posted Jan 20, 2017

Participant flow

34 patients enrolled; 33 patients completed the study from 11 U.S. sites.

Period A: Days -7 to -1

Participant flow — Period A: Days -7 to -1
Milestone	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)
Started	34	0	0	0
Completed	33	0	0	0
Not completed	1	0	0	0
Withdrew: Adverse event	1	0	0	0

Period B: Days 1 to 11

Participant flow — Period B: Days 1 to 11
Milestone	Crossover Period B: Placebo Then RELiZORB	Crossover Period B: RELiZORB Then Placebo
Started	17	16
Completed	17	16
Not completed	0	0

Period C: Days 12 to 20

Participant flow — Period C: Days 12 to 20
Milestone	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)
Started	0	0	0	33
Completed	0	0	0	33
Not completed	0	0	0	0

Outcome measures

PrimaryNumber 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)

Time frame:: 27 days
Reported as:: Count of participants · Participants

Number of Patients With Adverse Events and Unanticipated Adverse Device Effects
Participants	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
Patients With Adverse Events	4	6	1	2
Adverse Event by Severity (Mild)	2	6	1	0
Adverse Event by Severity (Moderate)	2	0	0	1
Adverse Event by Severity (Severe)	0	0	0	1
Patients With At Least One UADE	0	0	0	0

PrimaryLong 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

Time frame:: Day 1 first intervention and Day 9 second intervention.
Reported as:: Mean · ug*h/mL

Long Chain Polyunsaturated Fatty Acid Plasma Concentration (Intent to Treat Population)
ug*h/mL	RELiZORB	Control
Long Chain Polyunsaturated Fatty Acid Plasma Concentration (Intent to Treat Population)	536.98 ± 400.519	192.18 ± 198.664

Statistical analysis

RELiZORB vs Control · Mixed Models Analysis · p = <0.001The independent variables in the mixed model analysis included fixed effect factors for treatment (placebo or RELiZORB).

Other pre-specifiedEase 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.

Time frame:: Period C: Single assessment on Day 19 or 20
Reported as:: Count of participants · Participants

Ease of Use of RELiZORB (Per-Protocol Population)
Participants	Clinical Treatment Practice and Relizorb: Period C: Days 12-20
No breakfast	11
Small breakfast	14
Normal breakfast	6
Big breakfast	0
Other	1

Adverse events

Collected over 20 days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Clinical Treatment Practice: Period A: Days -7 to -1	—	1/33 (3%)	2/33 (6.1%)
Double-Blind Crossover: Period B: Days 1 to 11	—	0/33 (0%)	0/33 (0%)
Clinical Treatment Practice and Relizorb: Period C: Days 12-20	—	0/33 (0%)	0/33 (0%)

Most frequent serious events

Most frequent serious events
Event	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
Cystic fibrosis pulmonary exacerbationInfections and infestations	1/33	0/33	0/33

Most frequent other events

Most frequent other events
Event	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
HeadacheNervous system disorders	2/33	0/33	0/33

Baseline characteristics

Safety Population

Age, Categorical
Age, Categorical(Participants)	Clinical Treatment Practice: Period A: Days -7 to -1
<=18 years	27
Between 18 and 65 years	6
>=65 years	0

Sex: Female, Male
Sex: Female, Male(Participants)	Clinical Treatment Practice: Period A: Days -7 to -1
Female	13
Male	20

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Clinical Treatment Practice: Period A: Days -7 to -1
Hispanic or Latino	5
Not Hispanic or Latino	28
Unknown or Not Reported	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Clinical Treatment Practice: Period A: Days -7 to -1
American Indian or Alaska Native	0
Asian	0
Native Hawaiian or Other Pacific Islander	0
Black or African American	1
White	31
More than one race	0
Unknown or Not Reported	1

Region of Enrollment
Region of Enrollment(Participants)	Clinical Treatment Practice: Period A: Days -7 to -1
United States	33

Baseline Weight
Baseline Weight(kilograms)	Clinical Treatment Practice: Period A: Days -7 to -1
Mean	41.81 ± 13.332

Baseline Height
Baseline Height(centimeters)	Clinical Treatment Practice: Period A: Days -7 to -1
Mean	152.32 ± 19.640

Baseline Body Mass Index
Baseline Body Mass Index(kg/m^2)	Clinical Treatment Practice: Period A: Days -7 to -1
Mean	17.47 ± 2.026

Study locations

11 sites

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

References and documents

Publications

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. PubMed 28471913 ↗

Individual participant data

Plan to share: Undecided

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 25, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02598128
Lead sponsor: Alcresta Therapeutics, Inc.
Responsible party: Sponsor
First posted: Nov 5, 2015
Start date: Nov 2015
Primary completion: Jun 2016
Completion: Jun 2016
Results posted: Jan 20, 2017
Last update: Jan 25, 2017

Study contacts

Russell G. Clayton, Sr., DO

study director · Chief Medical Officer, Alcresta Therapeutics, Inc.

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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