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Trial record 1 of 18 for:    cystic fibrosis patient registry
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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)

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. Read our disclaimer for details.
 
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 LLC
Information provided by (Responsible Party):
AbbVie

Study Description
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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.

Condition or disease Intervention/treatment
Fibrosing Colonopathy Biological: ULTRESA Biological: PANCREAZE Biological: CREON Biological: ZENPEP Biological: other non-sponsor pancreatic enzyme replacement therapy Biological: PERTZYE Other: No pancreatic enzyme replacement therapy

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 Design
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Study Type : Observational
Actual Enrollment : 17 participants
Observational Model: Cohort
Time Perspective: Prospective
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)
Actual Study Start Date : July 31, 2012
Actual Primary Completion Date : April 8, 2020
Actual Study Completion Date : April 8, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Groups and Cohorts
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Group/Cohort Intervention/treatment
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: 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%)


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   0 Months to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cystic fibrosis patients who are active in the Cystic Fibrosis Patient Registry
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01652157


Locations
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Sponsors and Collaborators
AbbVie
Cystic Fibrosis Foundation
Digestive Care, Inc.
Nestle Health Science
VIVUS LLC
Investigators
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Study Director: Craig Peterson VIVUS LLC
More Information
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Additional Information:

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT01652157    
Other Study ID Numbers: CFFC-OB-11
First Posted: July 27, 2012    Key Record Dates
Last Update Posted: March 22, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by AbbVie:
prospective
observational
pancreatic insufficiency
 pancreatic enzyme replacement therapy
fibrosing colonopathy
patients with cystic fibrosis
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
 Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pancrelipase
Pancreatin
Gastrointestinal Agents