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

PHASE4CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

October 23, 2019

Primary Completion Date

July 11, 2022

Study Completion Date

July 11, 2022

Conditions
Cystic Fibrosis
Interventions
DRUG

Pancrelipase

Delayed release capsules

DRUG

Pancrelipase

Delayed release capsules

Trial Locations (13)

23219

Virginia Commonwealth University Medical Center Main Hospital /ID# 164574, Richmond

32207

Nemours Children's Health System /ID# 164553, Jacksonville

32803

Central FL Pulmonary Orlando /ID# 164558, Orlando

44106

UH Cleveland Medical Center /ID# 206095, Cleveland

44195

Cleveland Clinic Main Campus /ID# 212853, Cleveland

52242

University of Iowa Hospitals and Clinics /ID# 164551, Iowa City

60093

The Cystic Fibrosis Institute /ID# 210757, Northfield

90033

University of Southern California /ID# 164571, Los Angeles

93003-3099

Landon Pediatric Foundation /ID# 215411, Ventura

67214-2878

Via Christi Research /ID# 214266, Wichita

43205-2664

Nationwide Children's Hospital /ID# 225628, Columbus

19104-4319

Children's Hospital of Philadelphia - Main /ID# 208114, Philadelphia

37232-0011

Vanderbilt University Medical Center /ID# 213434, Nashville

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AbbVie

INDUSTRY