NCT01652157|TerminatedFDA Drug

Study Stopped

Strategic considerations

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)

AbbVie ClinicalTrials.gov

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1 other identifier

CFFC-OB-11

Study Type

observational

Target

Locations

1 country

Sites

123

Timeline

RegisteredJul 2012

StartedJul 2012

CompletionApr 2020

Brief Summary

This is a long-term study in cystic fibrosis patients who are participating in the Cystic Fibrosis Patient Registry to assess the occurrence and risk factors for a rare bowel disorder called fibrosing colonopathy (narrowing of the large intestine). Patients will be followed at their regular clinical care visits over a 10-year period and approached if they develop symptoms of fibrosing colonopathy for collection and use of further detailed information.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for all trials

Timeline

Completed

Started Jul 2012

Longer than P75 for all trials

Geographic Reach

1 country

123 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

7.7 years study duration

First Submitted

Initial submission to the registry

July 25, 2012

Completed

2 days until next milestone

First Posted

Study publicly available on registry

July 27, 2012

Completed

4 days until next milestone

Study Start

First participant enrolled

July 31, 2012

Completed

7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 8, 2020

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2020

Completed

Last Updated

March 22, 2021

Status Verified

March 1, 2021

Enrollment Period

7.7 years

First QC Date

July 25, 2012

Last Update Submit

March 18, 2021

Conditions

Fibrosing Colonopathy

Keywords

prospectiveobservationalpancreatic insufficiencypancreatic enzyme replacement therapyfibrosing colonopathypatients with cystic fibrosis

Outcome Measures

Primary Outcomes (7)

Incidence rate of fibrosing colonopathy confirmed by an independent adjudication panel in patients receiving ZENPEP
Fibrosing colonopathy is confirmed by an independent adjudication panel based on prospectively defined criteria.
up to 10 years
Incidence rate of fibrosing colonopathy confirmed by an independent adjudication panel in patients receiving ULTRESA
Fibrosing colonopathy is confirmed by an independent adjudication panel based on prospectively defined criteria.
up to 10 years
Incidence rate of fibrosing colonopathy confirmed by an independent adjudication panel in patients receiving PERTZYE.
Fibrosing colonopathy is confirmed by an independent adjudication panel based on prospectively defined criteria.
up to 10 years
Incidence rate of fibrosing colonopathy confirmed by an independent adjudication panel in patients receiving CREON
Fibrosing colonopathy is confirmed by an independent adjudication panel based on prospectively defined criteria.
up to 10 years
Incidence rate of fibrosing colonopathy confirmed by an independent adjudication panel in patients receiving PANCREAZE
Fibrosing colonopathy is confirmed by an independent adjudication panel based on prospectively defined criteria.
up to 10 years
Incidence rate of fibrosing colonopathy confirmed by an independent adjudication panel in patients not receiving pancreatic enzyme therapy.
Fibrosing colonopathy is confirmed by an independent adjudication panel based on prospectively defined criteria.
up to 10 years
Incidence rate of fibrosing colonopathy confirmed by an independent adjudication panel in patients receiving non-sponsor pancreatic enzyme replacement therapy
Fibrosing colonopathy is confirmed by an independent adjudication panel based on prospectively defined criteria.
up to 10 years

Secondary Outcomes (1)

Odds ratio (95% confidence interval) to quantify the association between possible risk factors and confirmed fibrosing colonopathy
up to 10 years

Study Arms (1)

Cystic fibrosis (CF) patients in the CF Patient Registry

Patients diagnosed with cystic fibrosis at participating sites who are providing data to the Cystic Fibrosis Patient Registry

Biological: ULTRESABiological: PANCREAZEBiological: CREONBiological: ZENPEPBiological: other non-sponsor pancreatic enzyme replacement therapyBiological: PERTZYEOther: No pancreatic enzyme replacement therapy