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Trial record 1 of 1 for:    fibrosing colonopathy
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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)

This study is currently recruiting participants.
Verified November 2017 by AbbVie ( AbbVie (prior sponsor, Abbott) )
Sponsor:
ClinicalTrials.gov Identifier:
NCT01652157
First Posted: July 27, 2012
Last Update Posted: November 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Cystic Fibrosis Foundation Therapeutics
Digestive Care, Inc.
Janssen Research & Development, LLC
Forest Research Institute, Inc., an Allergan affiliate
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
July 25, 2012
July 27, 2012
November 30, 2017
July 31, 2012
July 29, 2022   (Final data collection date for primary outcome measure)
  • Incidence rate of fibrosing colonopathy confirmed by an independent adjudication panel in patients receiving CREON [ Time Frame: up to 10 years ]
    Fibrosing colonopathy is confirmed by an independent adjudication panel based on prospectively defined criteria.
  • Incidence rate of fibrosing colonopathy confirmed by an independent adjudication panel in patients receiving ZENPEP [ Time Frame: up to 10 years ]
    Fibrosing colonopathy is confirmed by an independent adjudication panel based on prospectively defined criteria.
  • Incidence rate of fibrosing colonopathy confirmed by an independent adjudication panel in patients receiving ULTRESA [ Time Frame: up to 10 years ]
    Fibrosing colonopathy is confirmed by an independent adjudication panel based on prospectively defined criteria.
  • Incidence rate of fibrosing colonopathy confirmed by an independent adjudication panel in patients receiving PANCREAZE [ Time Frame: up to 10 years ]
    Fibrosing colonopathy is confirmed by an independent adjudication panel based on prospectively defined criteria.
  • Incidence rate of fibrosing colonopathy confirmed by an independent adjudication panel in patients receiving PERTZYE. [ Time Frame: up to 10 years ]
    Fibrosing colonopathy is confirmed by an independent adjudication panel based on prospectively defined criteria.
  • Incidence rate of fibrosing colonopathy confirmed by an independent adjudication panel in patients receiving non-sponsor pancreatic enzyme replacement therapy [ Time Frame: up to 10 years ]
    Fibrosing colonopathy is confirmed by an independent adjudication panel based on prospectively defined criteria.
  • Incidence rate of fibrosing colonopathy confirmed by an independent adjudication panel in patients not receiving pancreatic enzyme therapy. [ Time Frame: up to 10 years ]
    Fibrosing colonopathy is confirmed by an independent adjudication panel based on prospectively defined criteria.
  • Incidence rate of fibrosing colonopathy confirmed by an independent adjudication panel in patients receiving CREON [ Time Frame: up to 10 years ]
    Fibrosing colonopathy is confirmed by an independent adjudication panel based on prospectively defined criteria.
  • Incidence rate of fibrosing colonopathy confirmed by an independent adjudication panel in patients receiving ZENPEP [ Time Frame: up to 10 years ]
    Fibrosing colonopathy is confirmed by an independent adjudication panel based on prospectively defined criteria.
  • Incidence rate of fibrosing colonopathy confirmed by an independent adjudication panel in patients receiving ULTRESA [ Time Frame: up to 10 years ]
    Fibrosing colonopathy is confirmed by an independent adjudication panel based on prospectively defined criteria.
  • Incidence rate of fibrosing colonopathy confirmed by an independent adjudication panel in patients receiving PANCREAZE [ Time Frame: up to 10 years ]
    Fibrosing colonopathy is confirmed by an independent adjudication panel based on prospectively defined criteria.
  • Incidence rate of fibrosing colonopathy confirmed by an independent adjudication panel in patients receiving non-sponsor pancreatic enzyme replacement therapy [ Time Frame: up to 10 years ]
    Fibrosing colonopathy is confirmed by an independent adjudication panel based on prospectively defined criteria.
  • Incidence rate of fibrosing colonopathy confirmed by an independent adjudication panel in patients not receving pancreatic enzyme replacement therapy [ Time Frame: up to 10 years ]
    Fibrosing colonopathy is confirmed by an independent adjudication panel based on prospectively defined criteria.
Complete list of historical versions of study NCT01652157 on ClinicalTrials.gov Archive Site
Odds ratio (95% confidence interval) to quantify the association between possible risk factors and confirmed fibrosing colonopathy [ Time Frame: up to 10 years ]
Potential risk factors include demographics, medical history, and concurrent medications, including daily dosage and length of specific pancreatic enzyme replacement therapy.
Same as current
Not Provided
Not Provided
 
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)
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.

This is a prospective, observational, population-based cohort study in US cystic fibrosis patients participating in the Cystic Fibrosis Patient Registry in order to assess the incidence of and risk factors for fibrosing colonopathy. Cystic fibrosis (CF) patients participating in the registry from participating sites, as well as new CF patients enrolled in the registry at these sites over a 2-year period, will serve as the base study population (estimated to include 24,500-25,000 cystic fibrosis patients between the first patient encounter documented in the registry from any participating site and the 31st of July 2014). Cystic fibrosis patients in the base study population will be followed at their regular clinical care visits and, any patients presenting over a 10-year period with signs and symptoms of suspected fibrosing colonopathy, based on a prospective definition, will be approached to obtain a study-specific informed consent for collection of additional data outside the standard registry data collection form in order to augment surveillance. Data routinely collected via the standard CF registry will be used to determine exposure to any specific pancreatic enzyme replacement therapy and to assess potential risk factors for the outcome of confirmed fibrosing colonopathy. An independent adjudication panel will be utilized to validate the diagnosis of fibrosing colonopathy based on a prospective case definition as well as decision rules.

This harmonized protocol reflects equal sponsorship not only by the registering Sponsor, AbbVie, but also the Collaborators, Forest Research Institute, Inc., an Allergan affiliate, Janssen Research & Development and LLC. Digest Care, Inc.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Cystic fibrosis patients who are active in the Cystic Fibrosis Patient Registry
Fibrosing Colonopathy in Patients With Cystic Fibrosis
  • Biological: CREON
    pancreatic enzyme replacement therapy
    Other Name: pancrelipase
  • Biological: ZENPEP
    pancreatic enzyme replacement therapy
    Other Name: pancrelipase
  • Biological: ULTRESA
    pancreatic enzyme replacement therapy
    Other Name: pancrelipase
  • Biological: PANCREAZE
    pancreatic enzyme replacement therapy
    Other Name: pancrelipase
  • Biological: PERTZYE
    pancreatic enzyme replacement therapy
    Other Name: pancrelipase
  • Biological: other non-sponsor pancreatic enzyme replacement therapy
    pancreatic enzyme replacement therapy
    Other Name: pancrelipase
  • Other: No pancreatic enzyme replacement therapy
    Cystic fibrosis patients in the cystic fibrosis registry not receiving any pancreatic enzyme replacement therapy (approximately 10%)
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
Interventions:
  • Biological: CREON
  • Biological: ZENPEP
  • Biological: ULTRESA
  • Biological: PANCREAZE
  • Biological: PERTZYE
  • Biological: other non-sponsor pancreatic enzyme replacement therapy
  • Other: No pancreatic enzyme replacement therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
July 29, 2022
July 29, 2022   (Final data collection date for primary outcome measure)

Inclusion Criteria:

The inclusion criteria for enrollment in the Base Study Population

  • Diagnosed with cystic fibrosis,
  • Enrolled in the Cystic Fibrosis Patient Registry
  • Receiving medical care at a Cystic Fibrosis Foundation-accredited care center providing data to the Cystic Fibrosis Patient Registry

Exclusion Criteria:

Sexes Eligible for Study: All
up to 99 Years   (Child, Adult, Senior)
No
Contact: Christopher Dowd 301-841-2606 cdowd@cff.org
Contact: Barbra L Fogarty, BA 206-884-7592 barbra.fogarty@seattlechildrens.org
United States
 
 
NCT01652157
CFFC-OB-11
Not Provided
Not Provided
Not Provided
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
  • Cystic Fibrosis Foundation Therapeutics
  • Digestive Care, Inc.
  • Janssen Research & Development, LLC
  • Forest Research Institute, Inc., an Allergan affiliate
Study Director: Gerhard J Leitz Janssen Research & Development, LLC
AbbVie
November 2017