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NCT07335523

PHASE2

Management of Steatorrhea in Children and Young Adults With Alagille Syndrome After Liver Transplantation

Sponsor: Digestive Care, Inc.

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn if PERTZYE® works to treat steatorrhea in children and adults with Alagille Syndrome (ALGS) post liver transplant. It will also learn about the safety of PERTZYE®. The main questions it aims to answer are: * Does PERTZYE improve dietary fat absorption? * Does PERTZYE improve stool frequency and consistency? * Does PERTZYE improve abdominal signs and symptoms? * What medical problems do participants have when taking PERTZYE? Researchers will compare the results when participants are taking and stop taking PERTZYE. During the study, participants will: * Consume a high fat diet * Take PERTZYE every day with meals and snacks for up to 4 weeks * Have scheduled checkups by phone or video by clinical staff * Keep a diary of their symptoms and PERTZYE dosing * Collect stool for laboratory testing

Official title: A Phase 2 Treatment Withdrawal Clinical Trial of a Bicarbonate-Buffered, Enteric-Coated Pancreatic Enzyme Supplement for the Management of Steatorrhea in Children and Young Adults With Alagille Syndrome After Liver Transplantation

Key Details

Gender

All

Age Range

7 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-03

Completion Date

2028-03

Last Updated

2026-01-13

Healthy Volunteers

Conditions

Steatorrhea

Interventions

DRUG

Pertzye

PERTZYE (pancrelipase) delayed-release capsules

Inclusion Criteria: * Male and female participants ages 7-50 years inclusive. * Confirmed diagnosis of ALGS * Status post OLT due to ALGS complications. * Participants currently managed with pancreatic enzyme products (PEPs) are allowed pending discontinuation of PEPs for 5 days prior to beginning the 72-hour stool collections. Participants must discontinue PEPs for the entire study period until completion. * Agree to adhere to a high fat diet at least 2 days prior to and during the 72-hour stool collections and monitor dietary consumption through the use of a diet diary. * Presence of steatorrhea confirmed by baseline CFA ≤ 90%. * Have a consistent caregiver for the duration of the study if applicable for enrollment of a child. * Capable of giving written informed consent and assent (if age appropriate). Exclusion Criteria: * Surgical disruption of the enterohepatic circulation (e.g., biliary diversion). * Diets high in medium-chain triglyceride (MCT) oil. * Use of bile acids, bile acid uptake inhibitors, lipid-binding resins, synthetic fat substitutes (e.g. Olestra), and diaper rash ointments (note that H2 antagonists and proton pump inhibitors \[PPIs\] are permitted if on a stable and consistent regimen throughout the duration of the study). * History or presence of other concomitant liver diseases such as liver transplant rejection with cholestasis, hepatitis B or C virus infection, HIV, primary sclerosing cholangitis (PSC), alcoholic liver disease, autoimmune hepatitis, metabolic-associated fatty liver disease (MASLD)/non-alcoholic steatohepatitis (NASH) or significant chronic allograft rejection. * Currently pregnant or breastfeeding. * Cancers except for in situ carcinoma or cancers treated at least 5 years prior to screening with no evidence of recurrence. * Participation in a clinical trial and received an investigational product within the last 30 days. * Use of anti-diarrheal, anti-spasmodic, and/or cathartic laxatives. Change in osmotic laxatives within the past 3 months.