Phase 4
N=26
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
Cystic Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT03924947 ↗Enrolled (actual)
26
Serious AEs
1.5%
Results posted
Sep 2023
Primary outcome: Primary: Part 1 Coefficient of Fat Absorption (CFA) — 85.53; 84.59 percentage of fat intake absorbed
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Pancrelipase (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- AbbVie
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part 1 Coefficient of Fat Absorption (CFA) |
85.53; 84.59 | — |
| PRIMARY Part 2 Coefficient of Fat Absorption (CFA) |
87.74; 88.88 | — |
| SECONDARY Coefficient of Nitrogen Absorption (CNA) |
85.01; 85.04; 85.67; 86.50 | — |
| SECONDARY Stool Fat |
44.52; 47.88; 37.46; 34.19 | — |
| SECONDARY Stool Weight |
861.04; 826.36; 754.91; 771.47 | — |
Summary
Part 1 is a study to demonstrate that Creon (pancrelipase) delayed release (DR) capsules manufactured with a modernized process (MP) is non-inferior to currently marketed pancrelipase DR capsules in participants with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF), as measured by coefficient of fat absorption (CFA). Part 2 is a study to demonstrate that Creon (pancrelipase) manufactured with an alternate active pharmaceutical ingredient site (AAPIS) is non-inferior to currently marketed active control (Creon®) in participants with EPI due to CF, as measured by CFA. Safety is evaluated in each part.
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 moderate to severe Exocrine Pancreatic Insufficiency (EPI), as determined by Fecal Elastase 1 (FE-1) = 3 times the upper limit of normal values, or clinically significant (investigator opinion) elevation of uric acid.
Data sourced from ClinicalTrials.gov (NCT03924947). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.