Summary

for people ages up to 99 years (full criteria)
at Oakland, California and other locations
study started
estimated completion:

Description

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.

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)

Details

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, LLC; Digestive Care, Inc.

Keywords

Fibrosing Colonopathy prospective pancreatic insufficiency observational pancreatic enzyme replacement therapy Cystic Fibrosis Pancrelipase Pancreatin CREON ZENPEP ULTRESA PANCREAZE PERTZYE other non-sponsor pancreatic enzyme replacement therapy No pancreatic enzyme replacement therapy

Eligibility

You can join if…

Open to people ages up to 99 years

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

You CAN'T join if...

Locations

  • Children's Hospital and Research Center Oakland /ID# 79295 accepting new patients
    Oakland California 94609 United States
  • University of California, San Francisco /ID# 78925 accepting new patients
    San Francisco California 94143 United States
  • California Pacific Medical Center Research Institute /ID# 76775 accepting new patients
    San Francisco California 94115 United States
  • Kaiser Permanente /ID# 78899 accepting new patients
    Oakland California 94611 United States
  • Stanford University /ID# 95156 accepting new patients
    Palo Alto California 94304 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie (prior sponsor, Abbott)
Links
Prescribing Information for CREON
Prescribing Information for ZENPEP
Prescribing Information for PANCREAZE
ID
NCT01652157
Study Type
Observational
Last Updated
May 18, 2018