A Study to Compare US Marketed Creon Manufactured With a Modernized Process at an Alternate Manufacturing Site and Manufactured With the Approved Manufacturing Process at an Alternate Active Pharmaceutical Ingredient Site, in Participants With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis

• Register: ClinicalTrials.gov
• Last refreshed on: 9 October 2023
• Main ID: NCT03924947
• Date of registration: 18/04/2019
• Prospective Registration: Yes
• Primary sponsor: AbbVie
• Public title: A Study to Compare US Marketed Creon Manufactured With a Modernized Process at an Alternate Manufacturing Site and Manufactured With the Approved Manufacturing Process at an Alternate Active Pharmaceutical Ingredient Site, in Participants With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
• Scientific 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 and With Drug Product Manufactured With the Approved Manufacturing Process at an Alternate Active Pharmaceutical Ingredient Site, in Subjects With EPI Due to Cystic Fibrosis
• Date of first enrolment: October 23, 2019
• Target sample size: 36
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03924947
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

Spain, United States

Contacts

• Name: ABBVIE INC.
• Affiliation: AbbVie

Key inclusion & exclusion 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 moderate to severe Exocrine Pancreatic Insufficiency
(EPI), as determined by Fecal Elastase 1 (FE-1) < 15 µg/g at screening.

- 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 two (if participating in one of the parts) or four (if
participating in both parts) hospitalization/confinement periods of 6 to 8 days each
during the expected study window.

- Participant is able to consume a diet with 100 g fat/day, a minimum of 1 g/kg of
protein/day and normal to low fiber content.

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.



Age minimum: 12 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Drug: Pancrelipase

Primary Outcome(s)

Part 2 Coefficient of Fat Absorption (CFA) [Time Frame: Up to Day 8 of each DB treatment period]

Part 1 Coefficient of Fat Absorption (CFA) [Time Frame: Up to Day 8 of each DB treatment period]

Secondary Outcome(s)

Stool Fat [Time Frame: Up to Day 8 of each DB treatment period]

Stool Weight [Time Frame: Up to Day 8 of each DB treatment period]

Coefficient of Nitrogen Absorption (CNA) [Time Frame: Up to Day 8 of each DB treatment period]

Secondary ID(s)

2017-000578-12

M16-111

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 28/09/2023
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03924947