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: Completed Phase 4 study of Cystic Fibrosis, sponsored by AbbVie.

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. According to ClinicalTrials.gov, the official US trial registry.

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.

Primary Outcome

CFA is calculated as 100\*\[fat intake - fat excretion\]/fat intake. Fat intake was determined from fat content of food consumed on Day 3, 4, 5 of each treatment period. Fat excretion was determined from the content in the stool(s) collected after the first blue dyed stool (exclusive) following administration of the first blue dye marker (day 2) and until the first dyed stool (inclusive) following administration of the second blue dye marker (day 5) during each treatment period.

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
AbbVie

526 total trials

What the finished NCT03924947 record still lists

NCT03924947 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (80% lower).

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 lists 13 locations in 9 states (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.

Where NCT03924947's enrollment target sits among peer trials

36 107th of 169 higher than 61 of 169 other Cystic Fibrosis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Cystic Fibrosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT00929006 · 36 participants · Early Phase 1

    Acute Progesterone Suppression of Wake vs. Sleep Luteinizing Hormone Pulse Frequency in Pubertal Girls With and Without Hyperandrogenism

  • NCT01891318 · 36 participants · Phase 1

    Neoadjuvant Radiosurgery for Resectable Brain Metastases: Phase I/II Study

  • NCT02291848 · 36 participants · Phase 1

    Tumor-Associated Antigen-Specific Cytotoxic T-Lymphocytes for Multiple Myeloma

  • NCT02366819 · 36 participants · Phase 4

    Genetic Analysis-Guided Irinotecan Hydrochloride Dosing of mFOLFIRINOX in Treating Patients With Locally Advanced Gastroesophageal or Stomach Cancer

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Related registry views

Source: ClinicalTrials.gov NCT03924947, the US trial registry maintained by the National Library of Medicine. NCT03924947 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.