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Trial record 1 of 1 for:    Fibrosing Colonopathy in US Patients with Cystic Fibrosis
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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)

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ClinicalTrials.gov Identifier: NCT01652157
Recruitment Status : Terminated (Strategic considerations)
First Posted : July 27, 2012
Last Update Posted : March 22, 2021
Sponsor:
Collaborators:
Cystic Fibrosis Foundation
Digestive Care, Inc.
Nestle Health Science
VIVUS, Inc.
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date July 25, 2012
First Posted Date July 27, 2012
Last Update Posted Date March 22, 2021
Actual Study Start Date July 31, 2012
Actual Primary Completion Date April 8, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 17, 2018)
  • 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 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 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 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 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 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.
Original Primary Outcome Measures
 (submitted: July 25, 2012)
  • 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.
Change History
Current Secondary Outcome Measures
 (submitted: July 25, 2012)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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)
Official Title 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)
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.
Detailed Description 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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Cystic fibrosis patients who are active in the Cystic Fibrosis Patient Registry
Condition Fibrosing Colonopathy
Intervention
  • Biological: ULTRESA
    pancreatic enzyme replacement therapy
    Other Name: pancrelipase
  • Biological: PANCREAZE
    pancreatic enzyme replacement therapy
    Other Name: pancrelipase
  • Biological: CREON
    pancreatic enzyme replacement therapy
    Other Name: pancrelipase
  • Biological: ZENPEP
    pancreatic enzyme replacement therapy
    Other Name: pancrelipase
  • Biological: other non-sponsor pancreatic enzyme replacement therapy
    pancreatic enzyme replacement therapy
    Other Name: pancrelipase
  • Biological: PERTZYE
    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%)
Study Groups/Cohorts 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: ULTRESA
  • Biological: PANCREAZE
  • Biological: CREON
  • Biological: ZENPEP
  • Biological: other non-sponsor pancreatic enzyme replacement therapy
  • Biological: PERTZYE
  • Other: No pancreatic enzyme replacement therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: July 21, 2020)
17
Original Estimated Enrollment
 (submitted: July 25, 2012)
21960
Actual Study Completion Date April 8, 2020
Actual Primary Completion Date April 8, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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:

  • None
Sex/Gender
Sexes Eligible for Study: All
Ages up to 99 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01652157
Other Study ID Numbers CFFC-OB-11
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party AbbVie
Study Sponsor AbbVie
Collaborators
  • Cystic Fibrosis Foundation
  • Digestive Care, Inc.
  • Nestle Health Science
  • VIVUS, Inc.
Investigators
Study Director: Craig Peterson VIVUS, Inc.
PRS Account AbbVie
Verification Date March 2021