NCT03924947

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	Pancrelipase	Delayed release capsules
DRUG	Pancrelipase	Delayed release capsules

Timeline

• Start date: 2019-10-23
• Primary completion: 2022-07-11
• Completion: 2022-07-11
• First posted: 2019-04-23
• Last updated: 2023-09-28
• Results posted: 2023-09-28

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated drug study