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A Study to Compare US Marketed Pancrelipase Drug Product With Drug Product Manufactured With a Modernized Process at an Alternate Manufacturing Site, in Participants With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03924947
Recruitment Status : Recruiting
First Posted : April 23, 2019
Last Update Posted : January 6, 2020
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
This is a study to demonstrate that pancrelipase Delayed Release (DR) capsules manufactured with a Modernized Process (MP) is non-inferior to currently marketed pancrelipase DR capsules in participants with EPI due to Cystic Fibrosis (CF), as measured by Coefficient of Fat Absorption (CFA). Safety will also be evaluated.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Drug: Pancrelipase Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 4 Study to Compare US Marketed Creon Drug Product With Drug Product Manufactured With a Modernized Process at an Alternate Manufacturing Site, in Subjects With Exocrine Pancreatic Insufficiency (EPI) Due to Cystic Fibrosis
Actual Study Start Date : October 23, 2019
Estimated Primary Completion Date : July 18, 2020
Estimated Study Completion Date : February 22, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
Experimental: Arm A
Participants will receive Pancrelipase delayed release (DR) Capsules manufactured by modernized process uniform coated pellets (MP) in treatment period 1, followed by currently marketed Pancrelipase DR Capsules in treatment period 2.
Drug: Pancrelipase
Delayed release capsules
Other Names:
  • Creon
  • ABT-SLV-245

Experimental: Arm B
Participants will receive currently marketed Pancrelipase delayed release (DR) Capsules in treatment period 1, followed by Pancrelipase DR Capsules manufactured by modernized process uniform coated pellets (MP) in treatment period 2.
Drug: Pancrelipase
Delayed release capsules
Other Names:
  • Creon
  • ABT-SLV-245




Primary Outcome Measures :
  1. Coefficient of Fat Absorption (CFA) [ Time Frame: Up to Week 6 post randomization ]

    CFA is calculated as 100*[fat intake - fat excretion]/fat intake.

    Fat intake will be determined from fat content of food consumed. Fat excretion will be determined from the fat content in the stool(s) collected between the two dye markers.



Secondary Outcome Measures :
  1. Stool fat [ Time Frame: Up to Week 6 post randomization ]
    Total amount of fat excreted during the stool collection period.

  2. Coefficient of Nitrogen Absorption (CNA) [ Time Frame: Up to Week 6 post randomization ]
    The CNA is calculated as 100*[nitrogen intake - nitrogen excretion]/nitrogen intake.

  3. Stool weight [ Time Frame: Up to Week 6 post randomization ]
    Stool weight is assessed by weighing the stool(s).



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant has a documented diagnosis of Cystic Fibrosis (CF) confirmed by:

    • a sweat chloride test >= 60 mmol/L, and/or
    • documented CF-causing cystic fibrosis transmembrane conductance regulator (CFTR) mutations and clinical features of CF.
  • Participant has diagnosis of Exocrine Pancreatic Insufficiency (EPI) at screening proven by CFA < 70% without Pancreatic Enzyme Replacement Therapy (PERT) supplementation.
  • Participant has EPI that is currently clinically controlled (no clinically overt steatorrhea or diarrhea) under treatment with a commercially available Pancreatic Enzyme Replacement Therapy (PERT), on an individually established dose regimen for more than 3 months prior to Screening, with a daily dose not exceeding 4,000 Lipase Units (LU)/g fat/day or 10,000 LU/kg/day.
  • Participant is available for three hospitalization/confinement periods of 6 to 8 days each, one during the screening period and two during the expected study window.
  • Participant is able to consume the 100 g fat/day diet.

Exclusion Criteria:

  • BMI percentile for age less than 10% in participants less than 18 years of age.
  • Participant has a history of any of the following gastrointestinal disorders (acute pancreatitis within 6 months prior to Visit 2, chronic pancreatitis, fibrosing colonopathy, distal intestinal obstruction syndrome (DIOS) within 6 months prior to Visit 2, C. difficile infection within 6 months prior to Visit 2, celiac disease, gastric bypass or partial/total gastrectomy, Crohn's disease or other inflammatory bowel disease, small bowel surgery (other than minor resection due to meconium ileus without resultant malabsorption syndrome), or any type of malignancy involving the digestive tract in the last 5 years).
  • Participant has a history of any clinically significant endocrine, respiratory (except mild asthma or CF related lung disease), neurological, cardiac, renal, hepatic (including Hepatitis B or C), hematologic or psychiatric disease or disorder, or any other uncontrolled medical illness which might limit participation in or completion of the study.
  • Participant requires concomitant treatment with any medication not allowed by the protocol or a prohibited medication is expected to be needed during the study.
  • Participant is currently receiving nutritional supplementation via tube feeding (nasogastric, gastrostomy, jejunostomy).
  • Participant has clinically significant (as per Investigator's judgment) abnormalities in clinical chemistry, hematology, or urinalysis (excluding findings that are associated with CF) such as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels >= 3 times the upper limit of normal values, or clinically significant (investigator opinion) elevation of uric acid.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03924947


Contacts
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Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

Locations
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United States, California
Usc /Id# 164571 Not yet recruiting
Los Angeles, California, United States, 90033
Landon Pediatric Foundation /ID# 215411 Not yet recruiting
Ventura, California, United States, 93003-3099
United States, Florida
Nemours Childrens Specialty Ca /ID# 164553 Recruiting
Jacksonville, Florida, United States, 32207
Central FL Pulmonary Orlando /ID# 164558 Recruiting
Orlando, Florida, United States, 32803
United States, Georgia
Children's Healthcare of Atlanta - Ferry Rd /ID# 213433 Not yet recruiting
Atlanta, Georgia, United States, 30342-1605
United States, Illinois
Chicago Pulmonary Specialists /ID# 210757 Recruiting
Glenview, Illinois, United States, 60025-7645
United States, Iowa
University of Iowa Hospitals and Clinics /ID# 164551 Recruiting
Iowa City, Iowa, United States, 52242
United States, Kansas
Via Christi Research /ID# 214266 Recruiting
Wichita, Kansas, United States, 67214-2878
United States, Ohio
Cleveland Clinic Main Campus /ID# 212853 Not yet recruiting
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Children's Hosp of PA (CHOP) /ID# 208114 Recruiting
Philadelphia, Pennsylvania, United States, 19104-4399
United States, Tennessee
Vanderbilt Univ Med Ctr /ID# 213434 Not yet recruiting
Nashville, Tennessee, United States, 37232-0011
United States, Virginia
Virginia Commonwealth Univ /ID# 164574 Recruiting
Richmond, Virginia, United States, 23219
Spain
Hospital Univ Vall d'Hebron /ID# 165112 Not yet recruiting
Barcelona, Spain, 08035
Hosp Infantil Univ Nino Jesus /ID# 213460 Not yet recruiting
Madrid, Spain, 28009
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie

Additional Information:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03924947    
Other Study ID Numbers: M16-111
2017-000578-12 ( EudraCT Number )
First Posted: April 23, 2019    Key Record Dates
Last Update Posted: January 6, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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 and 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
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 (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

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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.: Yes
Keywords provided by AbbVie:
Cystic Fibrosis
Creon
Pancrelipase
ABT-SLV-245
Exocrine Pancreatic Insufficiency (EPI)
Modernized Process (MP)
Additional relevant MeSH terms:
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Cystic Fibrosis
Exocrine Pancreatic Insufficiency
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pancrelipase
Pancreatin
Gastrointestinal Agents