Terminated OBSERVATIONAL NCT01652157

Long-term Study in US Cystic Fibrosis Patients Receiving Digestive Enzyme Supplements to Assess Narrowing of the Large Intestine Causing Adverse Intestinal Symptoms (Fibrosing Colonopathy)

A Long-Term Prospective Observational Safety Study of the Incidence of and Risk Factors for Fibrosing Colonopathy in US Patients With Cystic Fibrosis Treated With Pancreatic Enzyme Replacement Therapy: A Harmonized Protocol Across Sponsors(The CF-FC Study)

Sponsor: AbbVie

Conditions Fibrosing Colonopathy

Interventions CREON No pancreatic enzyme replacement therapy PANCREAZE PERTZYE ULTRESA ZENPEP other non-sponsor pancreatic enzyme replacement therapy

Updated 18 times since 2017 Last updated: Mar 18, 2021 Started: Jul 31, 2012 Primary completion: Apr 8, 2020 Completion: Apr 8, 2020

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Strategic considerations

Other terminated trials from AbbVie

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This observational or N/A phase trial investigates Fibrosing Colonopathy and is currently terminated or withdrawn. AbbVie leads this study, which shows 18 recorded versions since 2012 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

18 versions recorded

Sep 2025 — Present [monthly]

Terminated
Sep 2024 — Sep 2025 [monthly]

Terminated
Jul 2024 — Sep 2024 [monthly]

Terminated
Mar 2022 — Jul 2024 [monthly]

Terminated
Apr 2021 — Mar 2022 [monthly]

Terminated

▶ Show 13 earlier versions

Jan 2021 — Apr 2021 [monthly]

Terminated
Aug 2020 — Jan 2021 [monthly]

Terminated

Status: Recruiting → Terminated
Jan 2020 — Aug 2020 [monthly]

Recruiting
Dec 2019 — Jan 2020 [monthly]

Recruiting
Jan 2019 — Dec 2019 [monthly]

Recruiting
Oct 2018 — Jan 2019 [monthly]

Recruiting
Jun 2018 — Oct 2018 [monthly]

Recruiting
Apr 2018 — Jun 2018 [monthly]

Recruiting

Phase: NA → None
Dec 2017 — Apr 2018 [monthly]

Recruiting NA
Sep 2017 — Dec 2017 [monthly]

Recruiting NA
Jun 2017 — Sep 2017 [monthly]

Recruiting NA
Feb 2017 — Jun 2017 [monthly]

Recruiting NA
Jan 2017 — Feb 2017 [monthly]

Recruiting NA

First recorded

Jul 2012

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

AbbVie
Cystic Fibrosis Foundation
Digestive Care, Inc.
Nestle Health Science
VIVUS LLC

Data source: AbbVie

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Akron, United States , Albany, United States , Altamonte Springs, United States , Anchorage, United States , Ann Arbor, United States , Atlanta, United States , Augusta, United States , Aurora, United States , Austin, United States , Baltimore, United States and 93 more locations