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

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.

Sponsors

Lead sponsor: AbbVie

Source 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.

Overall Status Recruiting
Start Date October 23, 2019
Completion Date February 22, 2021
Primary Completion Date July 18, 2020
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Coefficient of Fat Absorption (CFA) Up to Week 6 post randomization
Secondary Outcome
Measure Time Frame
Stool fat Up to Week 6 post randomization
Coefficient of Nitrogen Absorption (CNA) Up to Week 6 post randomization
Stool weight Up to Week 6 post randomization
Enrollment 28
Condition
Intervention

Intervention type: Drug

Intervention name: Pancrelipase

Description: Delayed release capsules

Eligibility

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.

Gender: All

Minimum age: 12 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
AbbVie Inc. Study Director AbbVie
Overall Contact

Last name: ABBVIE CALL CENTER

Phone: 847.283.8955

Email: [email protected]

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

Spain

United States

Verification Date

May 2020

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Arm A

Arm group type: Experimental

Description: 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.

Arm group label: Arm B

Arm group type: Experimental

Description: 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.

Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention model: Crossover Assignment

Primary purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov