RELiZORB for Pancreatic Insufficiency

Overseen By Casey M Luckhurst, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Massachusetts General Hospital

Disqualifiers: Chronic pancreatitis, GI cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 30

Duration: 14 days

60 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment RELiZORB for pancreatic insufficiency?

RELiZORB is a treatment designed to help people with pancreatic insufficiency who have trouble absorbing fats. It works by breaking down more than 90% of fats in enteral nutrition formulas into forms that the body can absorb, which can help improve nutrition in these patients. ^{1 2 3 4 5}

How is the treatment RELiZORB different from other treatments for pancreatic insufficiency?

RELiZORB is unique because it is an in-line digestive cartridge designed specifically for patients receiving enteral nutrition (tube feeding), efficiently breaking down fats into absorbable forms, unlike traditional enzyme replacement therapies that are not indicated for use with enteral nutrition. ^{1 6 7 8 9}

What is the purpose of this trial?

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.

Research Team

Casey M Luckhurst, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for hospitalized patients who need more than half of their daily nutrition through a feeding tube and have moderate to severe exocrine pancreatic insufficiency (EPI) due to pancreatitis. Participants must be able to consent and have a PEI-Q score of 1.4 or higher, indicating EPI.

Inclusion Criteria

I am currently in the hospital.

I am willing and able to agree to participate in the study.

I have been diagnosed with severe EPI, scoring 1.4 or higher on the PEI-Q.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tube feeds with or without RELiZORB to manage exocrine pancreatic insufficiency

14 days

Regular monitoring visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, including biochemical profile and stool assessment

90 days

Visits at 30, 60, and 90 days

Treatment Details

Interventions

• RELiZORB

Trial Overview The study tests RELiZORB's effectiveness in managing EPI for tube-fed patients with pancreatitis. Previously studied only in cystic fibrosis cases, this trial seeks to determine if RELiZORB can simplify enzyme delivery for these individuals.

Participant Groups

Group I: RELiZORB Experimental Treatment 1 Intervention

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

Group II: No RELiZORB Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Alcresta Therapeutics, Inc.

Industry Sponsor

Trials

6

Recruited

240+

Findings from Research

RELiZORB is a novel in-line digestive cartridge that effectively addresses the need for pancreatic enzyme replacement therapy (PERT) in patients with exocrine pancreatic insufficiency (EPI) receiving enteral nutrition, demonstrating compatibility with various formulas.

In clinical evaluations, RELiZORB was able to hydrolyze over 90% of fats in enteral nutrition formulas into absorbable fatty acids and monoglycerides, significantly improving fat absorption for patients who struggle with traditional long-chain triglycerides.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Options for addressing exocrine pancreatic insufficiency in patients receiving enteral nutrition supplementation. Freedman, SD.[2018]

Pancreatic enzyme replacement therapy is crucial for patients with exocrine pancreatic insufficiency, particularly those who have undergone surgery, have chronic pancreatitis, or cystic fibrosis, with lipase being essential to reduce fat malabsorption (steatorrhoea).

Different formulations of pancreatic enzymes, including porcine pancreatin and enteric-coated preparations, have varying effectiveness and must be tailored to individual patient needs, highlighting the importance of understanding both the patient's condition and the specific characteristics of the enzyme supplements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical and pharmacological aspects of pancreatic enzyme substitution therapy]. Löser, C., Fölsch, UR.[2006]

References

1. United States pubmed.ncbi.nlm.nih.gov

Options for addressing exocrine pancreatic insufficiency in patients receiving enteral nutrition supplementation. [2018]

2. Italy pubmed.ncbi.nlm.nih.gov

Post-surgical exocrine pancreatic insufficiency. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Real-World Patient Experience With Pancreatic Enzyme Replacement Therapy in the Treatment of Exocrine Pancreatic Insufficiency. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

A Retrospective Real-World Evidence Evaluation of the Characteristics of Exocrine Pancreatic Insufficiency in Patients With Chronic Pancreatitis and Type 2 Diabetes Treated With Pancrelipase in the United States. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Rationale for the use of cimetidine in pancreatic insufficiency. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Pancrelipase/Pancreatin in Patients With Exocrine Pancreatic Insufficiency and a Medical History of Diabetes Mellitus. [2017]

7. Germany pubmed.ncbi.nlm.nih.gov

[Clinical and pharmacological aspects of pancreatic enzyme substitution therapy]. [2006]

8. United States pubmed.ncbi.nlm.nih.gov

Development of pancreatic enzyme microsphere technology and US findings with Pancrease in the treatment of chronic pancreatitis. [2005]

9. United States pubmed.ncbi.nlm.nih.gov

Treatment of pancreatic exocrine deficiency. [2018]