Study to Evaluate Symptoms of Exocrine Pancreatic Insufficiency in Adult Participants With Cystic Fibrosis or Chronic Pancreatitis Treated With Creon

A Phase 4 Study to Assess Symptoms of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis or Chronic Pancreatitis Treated With Creon® (Pancrelipase) With an Alternate Source of Active Pharmaceutical Ingredient

Exocrine pancreatic insufficiency (EPI) is a condition that is caused by the inadequate pancreatic enzymes needed for normal digestion and is commonly associated with a wide range of chronic diseases, including cystic fibrosis (CF), chronic pancreatitis (CP), and pancreatic cancer. This study will assess clinical symptoms when participants with CF or CP are treated with Creon with alternate source of active drug.

Creon is an approved drug for the treatment of EPI. This study is subject-blinded which means participants will not know the source of the study drug they are given. Approximately 30 adult participants with CF or CP will be enrolled at approximately 15 sites across the Unites States.

Participants will receive oral capsules of CREON for 113 days and will be followed for 30 days.

Participants will attend regular visits during the study at a hospital or clinic or via telemedicine. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.

Study Overview

• Status: Completed
• Conditions: Cystic Fibrosis; Chronic Pancreatitis
• Intervention / Treatment: Drug: CREON

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36608-1771
      • Velocity Clinical Research /ID# 231076
  • California
    • Madera, California, United States, 93636
      • Valley Children's Hospital /ID# 231452
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida - Archer /ID# 233411
    • Margate, Florida, United States, 33063-5737
      • Atlantic Medical Research /ID# 239568
    • Miami, Florida, United States, 33136
      • University of Miami, Miller School of Medicine /ID# 239415
    • Naples, Florida, United States, 34102-5449
      • GI Pros /ID# 239486
    • Orlando, Florida, United States, 32803
      • Central FL Pulmonary Orlando /ID# 245863
  • Idaho
    • Nampa, Idaho, United States, 83687
      • Asr, Llc /Id# 239566
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • UMass Chan Medical School /ID# 230476
  • Missouri
    • Columbia, Missouri, United States, 65211
      • The Curators of the University of Missouri /ID# 233331
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center /ID# 231633
  • New York
    • Albany, New York, United States, 12208-3504
      • Albany Medical College-Pulmonary /ID# 250041
    • New York, New York, United States, 10016-2708
      • NYU Langone Health /ID# 233417
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157-0001
      • Wake Forest Baptist Health /ID# 229537
  • Ohio
    • Cincinnati, Ohio, United States, 45267-0585
      • University of Cincinnati /ID# 229511
    • Cleveland, Ohio, United States, 44106
      • UH Cleveland Medical Center /ID# 246065
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Main Campus /ID# 245864
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • Options Health Research, LLC /ID# 239535
  • Texas
    • Houston, Texas, United States, 77030-4202
      • Baylor College of Medicine Medical Center /ID# 233441
    • San Antonio, Texas, United States, 78229-3901
      • Univ Texas HSC San Antonio /ID# 239060
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University Hospitals /ID# 239593

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Previous diagnosis of cystic fibrosis (CF) or chronic pancreatitis (CP).
• Previous diagnosis of exocrine pancreatic insufficiency (EPI) that is currently clinically controlled.
• Total Symptom Score (TSS) < 1.8 on Pancreatic Exocrine Insufficiency Questionnaire (PEI-Q) at Screening.

Exclusion Criteria:

- Malignancy involving the digestive tract in the last 5 years, or other significant disease or medical condition that may interfere with EPI symptom assessment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Run-in Period: Creon-ABT; Participants will receive Creon-ABT daily for 28 days.	Drug: CREON; Capsule; Oral; Other Names: Pancrelipase
Experimental: Treatment Period: Creon-AAPIS; Participants will receive Creon-AAPIS daily for 85 days.	Drug: CREON; Capsule; Oral; Other Names: Pancrelipase

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in Total Symptom Score (TSS) From Day 1 (Baseline) to Days 8, 15, 29, and 85	The Pancreatic Exocrine Insufficiency Questionnaire (PEI-Q) is an 18-item Patient-Reported Outcome (PRO) instrument that assesses EPI symptoms and associated impact over the previous 7 days. All items are scored using a 5-point Likert scale (Not at all to Yes, a lot). The average score for each symptom domain is calculated, ranging from 0 to 4. TSS is calculated from the average of the mean abdominal domain score and the mean bowel movement symptom score. A numerically higher response indicates more severe EPI symptoms. Positive changes from baseline indicate a worsening of symptoms.	Day 1 (baseline), 8, 15, 29, and 85
Mean Change in Abdominal Symptom Domain Score (ASDS) From Day 1 (Baseline) to Days 8, 15, 29, and 85	The PEI-Q is an 18-item PRO instrument that assesses EPI symptoms and associated impact over the previous 7 days. All items are scored using a 5-point Likert scale (Not at all to Yes, a lot). The average score for each symptom domain is calculated, ranging from 0 to 4. ASDS is the mean abdominal symptom domain score measured by the PEI-Q. A numerically higher response indicates more severe EPI symptoms. Positive changes from baseline indicate a worsening of symptoms.	Day 1 (Baseline), 8, 15, 29, and 85
Mean Change in Bowel Movement Symptom Score (BMSS) From Day 1 (Baseline) to Days 8, 15, 29, and 85	The PEI-Q is an 18-item PRO instrument that assesses EPI symptoms and associated impact over the previous 7 days. All items are scored using a 5-point Likert scale (Not at all to Yes, a lot). The average score for each symptom domain is calculated, ranging from 0 to 4. BMSS is the mean bowel movement symptom domain score measured by the PEI-Q. A numerically higher response indicates more severe EPI symptoms. Positive changes from baseline indicate a worsening of symptoms.	Day 1 (Baseline), 8, 15, 29, and 85

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related info

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2021
• Primary Completion (Actual): July 7, 2023
• Study Completion (Actual): August 28, 2023

Study Registration Dates

• First Submitted: September 27, 2021
• First Submitted That Met QC Criteria: September 27, 2021
• First Posted (Actual): October 6, 2021

Study Record Updates

• Last Update Posted (Actual): July 23, 2024
• Last Update Submitted That Met QC Criteria: June 26, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Cystic Fibrosis; Exocrine Pancreatic Insufficiency; Chronic Pancreatitis; Pancrelipase; Creon
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Chronic Disease; Fibrosis; Cystic Fibrosis; Pancreatitis; Pancreatitis, Chronic; Exocrine Pancreatic Insufficiency; Gastrointestinal Agents; Pancrelipase
• Other Study ID Numbers: M21-432

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• IPD Sharing Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No