Exocrine Pancreatic InsufficiencyNCT02598128

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

A study testing RELiZORB in people with Exocrine Pancreatic Insufficiency, run by Alcresta Therapeutics, Inc. at 11 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 4 to 45 years
Conditions the study is for: Exocrine Pancreatic Insufficiency
What is being tested?: RELiZORB
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 34 participants
Where: 11 sitesUnited States
Study dates: Nov 2015to Jun 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 4 to 45 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

United States11 sites

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

Other trials in United States

About this study

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

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: Exocrine Pancreatic Insufficiency
Being tested: RELiZORB, Placebo
Medical subject headings: Exocrine Pancreatic Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RELiZORBDevice
Also called Peptamen 1.5, Impact Peptide 1.5
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.
PlaceboDevice
Sham device

Study groups in NCT02598128
Study group	Role	What they receive
RELiZORB	Experimental	Treatment (RELiZORB) Receives: Device: RELiZORB
Control	Placebo comparator	Placebo control Receives: Device: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 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
Measured: Day 1 first intervention and Day 9 second intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2015Jun 2016

First posted5 Nov 2015 (estimated)
Study startNov 2015
Primary completionJun 2016
Study completionJun 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Exocrine Pancreatic InsufficiencyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02598128
Sponsor's protocol ID: ALCT-0000497
Status last verified: Jan 2017
First submitted: 3 Nov 2015
Last updated: 25 Jan 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Undecided

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Comparative Study to Evaluate Microbial Versus Porcine Pancreatic Enzyme Therapy in Chronic Pancreatitis
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All Exocrine Pancreatic Insufficiency trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02598128
Acronym / sponsor ID: ALCT-0000497
Conditions: Exocrine Pancreatic Insufficiency
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: Alcresta Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: Nov 2015
Primary completion: Jun 2016 (actual)
Study completion: Jun 2016 (actual)
First posted: 5 Nov 2015 (estimated)
Results: Posted 20 Jan 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
RELiZORB	Experimental	Device: RELiZORBTreatment (RELiZORB)
Control	Placebo comparator	Device: PlaceboPlacebo control

Who may qualify

Ages: 4 to 45 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RELiZORBAlso: Peptamen 1.5, Impact Peptide 1.5Peptamen 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.	Device	RELiZORB
PlaceboSham device	Device	Control

Primary outcome

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)
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

Results and safety

Results posted to the registry on 20 Jan 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Period A: Clinical Treatment Practice (Days -7 to -1)	34	33
Crossover Period B: Placebo Then RELiZORB	0	0
Crossover Period B: RELiZORB Then Placebo	0	0
Period C: Clinical Treatment Practice + RELiZORB (Days 12-20)	0	0

Primary outcome: Number of Patients With Adverse Events and Unanticipated Adverse Device Effects

Time frame: 27 days. Count of participants. Unit: Participants

Measure	Clinical Treatment Practice: Period A: Days -7 to -1 n = 33	Crossover Period B: Placebo n = 33	Crossover Period B: RELiZORB n = 33	Clinical Treatment Practice + RELiZORB: Period C: Days 12-20 n = 33
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

Population analysed: Safety Population

Primary outcome: Long Chain Polyunsaturated Fatty Acid Plasma Concentration (Intent to Treat Population)

Time frame: Day 1 first intervention and Day 9 second intervention.. Mean (Standard Deviation). Unit: ug*h/mL

Measure	RELiZORB n = 33	Control n = 33
Value	536.98 (400.519)	192.18 (198.664)

RELiZORB vs Control: p <0.001, Mixed Models Analysis

Adverse events

Time frame: 20 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Clinical Treatment Practice: Period A: Days -7 to -1	1 of 33 (3%)	2 of 33 (6.1%)	Not reported
Double-Blind Crossover: Period B: Days 1 to 11	0 of 33 (0%)	0 of 33 (0%)	Not reported
Clinical Treatment Practice and Relizorb: Period C: Days 12-20	0 of 33 (0%)	0 of 33 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28471913Freedman 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.
Individual participant dataSharing planned: Undecided

Related trials for Exocrine Pancreatic Insufficiency

RecruitingObservational study
Cancer in Inherited Bone Marrow Failure Syndromes
Diamond Blackfan Anemia, Dyskeratosis Congenita
RecruitingPhase 2
Phase 2 Study to Assess the Safety and Efficacy of ANG003
Exocrine Pancreatic Insufficiency (EPI), Cystic Fibrosis (CF)
RecruitingObservational study
Determine the Prevalence of Exocrine Pancreatic Insufficiency (EPI) in Pediatric and Adult Participants With Alagille Syndrome After Liver Transplantation
Exocrine Pancreatic Insuficiency
RecruitingPhase 3
Comparative Study to Evaluate Microbial Versus Porcine Pancreatic Enzyme Therapy in Chronic Pancreatitis
Pancreatitis, Chronic, Exocrine Pancreatic Insufficiency (EPI)
Active, not recruitingPhase 4
A Study Of Effect Of Secretin For In Injection (Chirostim) On Pancreatic Fluid Composition In Healthy Subjects
Exocrine Pancreatic Insufficiency, Chronic Pancreatitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Russell G. Clayton, Sr., DO study director

Chief Medical Officer, Alcresta Therapeutics, Inc.

11 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing RELiZORB in people with Exocrine Pancreatic Insufficiency, run by Alcresta Therapeutics, Inc. at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients With Adverse Events and Unanticipated Adverse Device Effects (time frame: 27 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02598128, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2017.