Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT03924947 · ClinicalTrials.gov registry record · Phase 4

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 of Cystic Fibrosis, sponsored by AbbVie.

Completed
Registry status
Phase 4
Development phase
36
Enrollment target
13
Study locations

NCT03924947 is a Phase 4 study of Cystic Fibrosis that has completed, run by AbbVie. The registered enrollment target is 36 participants, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (80% lower). The trial reports 13 study locations across 9 states.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT03924947, a Phase 4 study of Cystic Fibrosis, has completed, sponsored by AbbVie.

COMPLETED
Registry status
Phase 4
Development phase
36 participants
Enrollment target
13
Study locations

Study 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 Studied

Cystic Fibrosis

Interventions

  • DRUG Pancrelipase

Study Locations (13)

Ohio

  • UH Cleveland Medical Center /ID# 206095 - Cleveland
  • Cleveland Clinic Main Campus /ID# 212853 - Cleveland
  • Nationwide Children's Hospital /ID# 225628 - Columbus

California

  • University of Southern California /ID# 164571 - Los Angeles
  • Landon Pediatric Foundation /ID# 215411 - Ventura

Florida

  • Nemours Children's Health System /ID# 164553 - Jacksonville
  • Central FL Pulmonary Orlando /ID# 164558 - Orlando

Illinois

  • The Cystic Fibrosis Institute /ID# 210757 - Northfield

Iowa

  • University of Iowa Hospitals and Clinics /ID# 164551 - Iowa City

Kansas

  • Via Christi Research /ID# 214266 - Wichita

Pennsylvania

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

Tennessee

  • Vanderbilt University Medical Center /ID# 213434 - Nashville

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2019-10-23
Est. Completion 2022-07-11
Phase Phase 4

Sponsor

AbbVie

526 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03924947

The ClinicalTrials.gov registry entry for NCT03924947 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (80% lower). The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Cystic Fibrosis appearing as the primary indexed condition, and to 1 intervention - of which Pancrelipase is the first listed.

NCT03924947 reports 13 study locations spanning 9 distinct geographic areas - top geographies include Ohio, California, Florida.

Frequently Asked Questions

What is clinical trial NCT03924947 about?

NCT03924947 is a clinical study titled "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". 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...

What is the current status of trial NCT03924947?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 36 participants. The study started on 2019-10-23. Estimated completion is 2022-07-11.

What conditions does trial NCT03924947 study?

This clinical trial studies the following conditions: Cystic Fibrosis.

What interventions are being tested in trial NCT03924947?

The interventions under investigation include: Pancrelipase (DRUG).

Who is sponsoring clinical trial NCT03924947?

This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03924947 being conducted?

This trial has 13 study locations across California, Florida, Illinois, Iowa, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Cystic Fibrosis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Explore more on PlainTrial

Cystic Fibrosis

All registered trials for this condition

California

All trials with a study site in California

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.