Evaluating the Efficacy of RELiZORB in Managing Exocrine Pancreatic Insufficiency in Tube-fed Pancreatitis Patients

NCT06691893 | Recruiting Phase 3 FDA Device

• 1 other identifier: 2024p002758
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This research aims to improve the management of exocrine pancreatic insufficiency (EPI), a condition that can develop after pancreatitis, a painful inflammation of the pancreas. EPI occurs when the pancreas does not produce enough enzymes to help the body properly digest food. While pancreatic enzyme replacement therapy (PERT) is commonly used to manage EPI symptoms, it can be challenging for people who rely on feeding tubes. RELiZORB, could help these patients by simplifying the delivery of the enzymes they need. However, RELiZORB has only been studied in people with EPI caused by cystic fibrosis, so its effectiveness in pancreatitis patients remains unknown. This study aims to determine whether RELiZORB is effective for individuals requiring feeding tube support after pancreatitis.

Conditions

Exocrine Pancreatic Insufficiency (EPI); Pancreatitis

Keywords

exocrine pancreatic insufficiency; pancreatitis; RELiZORB; lipase; enteral nutrition

Outcome Measures

Primary Outcomes (1)

• Pancreatic Exocrine Insufficiency Questionnaire (PEI-Q)

  The PEI-Q is an 18-item Patient-Reported Outcome (PRO) questionnaire designed to help individuals with pancreatic exocrine insufficiency (PEI) assess their symptoms and the impact on their health-related quality of life. Created and validated by Adelphi Values UK in collaboration with Abbott, the PEI-Q is available for use in clinical studies without the need to purchase a license. The scoring system ranges from 0 to 4, with higher scores indicating more severe symptoms. A score between 0.6 and 1.4 reflects mild PEI, 1.4 to 1.8 indicates moderate PEI, and a score of 1.8 or higher signifies severe or poorly controlled PEI. Our primary outcome measure is examining the change in baseline PEI-Q symptom score.

  Measured at 14 days from randomization

Secondary Outcomes (4)

• Time to treatment failure

  Measured up to 14 days from randomization

• Biochemical Profile

  Measured at 30, 60, and 90 days from randomization

• Stool Assessment

  Measured at 30, 60, and 90 days from randomization

• Time to oral nutrition

  Measured up to 90 days from randomization

Study Arms (2)

No RELiZORB

NO INTERVENTION

Patients will receive tube feeds (via nasogastric or nasojejunal tube) without the use of RELiZORB

RELiZORB

EXPERIMENTAL

Patients will receive tube feeds (via nasogastric or nasojejunal tube) with the use of RELiZORB

Device: RELiZORB

Interventions

RELiZORB DEVICE

RELiZORB (immobilized lipase) is a therapeutic device designed to enhance fat absorption in patients receiving enteral tube feedings. It works by hydrolyzing fats found in enteral formulas. RELiZORB is a single-use cartridge that connects in-line with enteral feeding sets. It contains lipase covalently bound to small polymer beads, forming a complex called iLipase, which remains within the cartridge. As the enteral formula passes through the cartridge, its fat content is hydrolyzed upon contact with iLipase. This process is especially beneficial for the absorption of long-chain polyunsaturated fatty acids, which require hydrolysis by pancreatic lipase for proper intestinal absorption. RELiZORB is compatible with a wide variety of commercially available enteral formulas.

Also known as: Immobilized Lipase

RELiZORB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient diagnosed with moderate or severe exocrine pancreatic insufficiency (EPI), as defined using the Pancreatic Exocrine Insufficiency Questionnaire (PEI-Q) symptom score of 1.4 or greater.
• Patient diagnosed with acute, recurrent acute pancreatitis or subacute pancreatitis. Subacute pancreatitis is defined as recent diagnosis of acute pancreatitis with sequelae of the acute episode including infection, pseudocyst, walled-off pancreatic necrosis.
• Patient is currently admitted to the hospital at the time of study enrollment.
• Patient requiring at least 50% of daily caloric and fluid intake through enteral tube feeds.
• Patient is able and willing to provide informed consent.

You may not qualify if:

• Patient with chronic pancreatitis
• Patient is currently intubated and unable to provide consent
• Patient with active gastrointestinal tract cancer
• Patient requiring less than 50% of nutritional support at time of enrollment
• Patient is unable to tolerate any form of enteral nutrition

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Alcresta Therapeutics, Inc.: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Related Publications (3)

• Stevens J, Wyatt C, Brown P, Patel D, Grujic D, Freedman SD. Absorption and Safety With Sustained Use of RELiZORB Evaluation (ASSURE) Study in Patients With Cystic Fibrosis Receiving Enteral Feeding. J Pediatr Gastroenterol Nutr. 2018 Oct;67(4):527-532. doi: 10.1097/MPG.0000000000002110.

  PMID: 30074573 BACKGROUND

• Johnson CD, Williamson N, Janssen-van Solingen G, Arbuckle R, Johnson C, Simpson S, Staab D, Dominguez-Munoz E, Levy P, Connett G, Lerch MM. Psychometric evaluation of a patient-reported outcome measure in pancreatic exocrine insufficiency (PEI). Pancreatology. 2019 Jan;19(1):182-190. doi: 10.1016/j.pan.2018.11.013. Epub 2018 Nov 27.

  PMID: 30528109 BACKGROUND

• Johnson CD, Arbuckle R, Bonner N, Connett G, Dominguez-Munoz E, Levy P, Staab D, Williamson N, Lerch MM. Qualitative Assessment of the Symptoms and Impact of Pancreatic Exocrine Insufficiency (PEI) to Inform the Development of a Patient-Reported Outcome (PRO) Instrument. Patient. 2017 Oct;10(5):615-628. doi: 10.1007/s40271-017-0233-0.

  PMID: 28332032 BACKGROUND

MeSH Terms

Conditions

Exocrine Pancreatic Insufficiency; Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Study Officials

• Casey M Luckhurst, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Casey M Luckhurst, MD

CONTACT

617-726-2760; cluckhurst@mgb.org

Yasmin G Hernandez-Barco, MD

CONTACT

yhernandez-barco@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 18, 2024
• Study Start: March 28, 2025
• Primary Completion (Estimated): April 15, 2027
• Study Completion (Estimated): July 15, 2027
• Last Updated: April 13, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)