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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 August 2017 by AbbVie ( AbbVie (prior sponsor, Abbott) )
Sponsor:
ClinicalTrials.gov Identifier:
NCT01652157
First Posted: July 27, 2012
Last Update Posted: September 1, 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 Laboratories
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
  Purpose
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 Intervention
Fibrosing Colonopathy in Patients With Cystic Fibrosis Biological: CREON Biological: ZENPEP Biological: ULTRESA Biological: PANCREAZE Biological: other non-sponsor pancreatic enzyme replacement therapy Other: No pancreatic enzyme replacement therapy Biological: PERTZYE

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):

Primary Outcome Measures:
  • 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 receiving 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:
  • 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.


Estimated Enrollment: 50
Study Start Date: July 31, 2012
Estimated Study Completion Date: July 29, 2022
Estimated Primary Completion Date: July 29, 2022 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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: 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: 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 patient registry not receiving any pancreatic enzyme replacement therapy (approximately 10%)
Biological: PERTZYE
pancreatic enzyme replacement therapy
Other Name: pancrelipase

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.

This harmonized protocol reflects equal sponsorship not only by the registering Sponsor, AbbVie, but also the Collaborators, Aptalis Pharma and Janssen Research & Development, LLC.

  Eligibility

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.


Ages Eligible for Study:   up to 99 Years   (Child, Adult, Senior)
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:

  Contacts and Locations
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


Contacts
Contact: Christopher Dowd 301-841-2606 cdowd@cff.org
Contact: Barbra L Fogarty, BA 206-884-7592 barbra.fogarty@seattlechildrens.org

  Hide Study Locations
Locations
United States, Alabama
Children's Hospital of Alabama /ID# 78920 Recruiting
Birmingham, Alabama, United States, 35233
United States, Alaska
Alaska Medical Center /ID# 79256 Recruiting
Anchorage, Alaska, United States, 99508
United States, Arizona
Phoenix Childrens Hospital /ID# 78906 Recruiting
Phoenix, Arizona, United States, 85016
University of Arizona /ID# 78939 Recruiting
Tucson, Arizona, United States, 85724
United States, Arkansas
Arkansas Children's Hospital /ID# 79265 Recruiting
Little Rock, Arkansas, United States, 72202
University of Arkansas for Medical Sciences /ID# 76785 Recruiting
Little Rock, Arkansas, United States, 72205
United States, California
University of California San Diego Health System /ID# 105039 Recruiting
La Jolla, California, United States, 92037
Loma Linda University School of Medicine /ID# 79237 Recruiting
Loma Linda, California, United States, 92354
Miller Childrens Hospital of Long Beach /ID# 78896 Recruiting
Long Beach, California, United States, 90806
Kaiser Permanente, Los Angeles Medical Center /ID# 79235 Recruiting
Los Angeles, California, United States, 90027
University of Southern California /ID# 76793 Recruiting
Los Angeles, California, United States, 90033
Children's Hospital and Research Center Oakland /ID# 79295 Recruiting
Oakland, California, United States, 94609
Kaiser Permanente /ID# 78899 Recruiting
Oakland, California, United States, 94611
Stanford University /ID# 95156 Recruiting
Palo Alto, California, United States, 94304
University of California Davis /ID# 118935 Recruiting
Sacramento, California, United States, 95817
California Pacific Medical Center Research Institute /ID# 76775 Recruiting
San Francisco, California, United States, 94115
University of California, San Francisco /ID# 78925 Recruiting
San Francisco, California, United States, 94143
United States, Colorado
Children's Hospital Colorado /ID# 79277 Recruiting
Aurora, Colorado, United States, 80045
National Jewish Health /ID# 76784 Recruiting
Denver, Colorado, United States, 80206
United States, Connecticut
Connecticut Childrens Medical Center /ID# 78923 Recruiting
Hartford, Connecticut, United States, 06106
Yale Univ School of Medicine /ID# 78940 Recruiting
New Haven, Connecticut, United States, 06520
United States, Delaware
Nemours/ Alfred I. duPont Hospital for Children /ID# 78945 Recruiting
Wilmington, Delaware, United States, 19803
United States, District of Columbia
Children's National Medical Center /ID# 79373 Recruiting
Washington, D.C., District of Columbia, United States, 20010
United States, Florida
Central Florida Pulmonary Group, PA /ID# 76776 Recruiting
Altamonte Springs, Florida, United States, 32701
University of Florida /ID# 76790 Recruiting
Gainesville, Florida, United States, 32610
University of Florida /ID# 78928 Recruiting
Gainesville, Florida, United States, 32610
Joe DiMaggio's Children Hospital /ID# 79234 Recruiting
Hollywood, Florida, United States, 33021
Nemours Children's Clinic Florida /ID# 78898 Recruiting
Jacksonville, Florida, United States, 32207
University of Miami , Miller School of Medicine /ID# 78927 Recruiting
Miami, Florida, United States, 33136
Arnold Palmer Hospital for Children /ID# 96075 Completed
Orlando, Florida, United States, 32806
Nemours Children's Clinic /ID# 78917 Recruiting
Orlando, Florida, United States, 32806
All Children's Hospital Outpatient Care Center /ID# 79264 Recruiting
Saint Petersburg, Florida, United States, 33701
Tampa General Hospital /ID# 76783 Recruiting
Tampa, Florida, United States, 33606
United States, Georgia
Emory University /ID# 79394 Recruiting
Atlanta, Georgia, United States, 30322
Children's Healthcare of Atlanta /ID# 116275 Recruiting
Atlanta, Georgia, United States, 30342
Augusta University /ID# 79395 Recruiting
Augusta, Georgia, United States, 30912
United States, Idaho
St. Lukes Cystic Fibrosis Center of Idaho /ID# 79259 Recruiting
Boise, Idaho, United States, 83712
United States, Illinois
Childrens Hospital of Chicago /ID# 79296 Recruiting
Chicago, Illinois, United States, 60611
The University of Chicago Medical Center /ID# 78924 Recruiting
Chicago, Illinois, United States, 60637
Loyola University Medical Center /ID# 76780 Recruiting
Maywood, Illinois, United States, 60153
Advocate Lutheran General Children's Hospital /ID# 76781 Recruiting
Park Ridge, Illinois, United States, 60068
OSF Saint Francis Medical Center /ID# 78905 Recruiting
Peoria, Illinois, United States, 61603
United States, Indiana
Lutheran Hospital of Indiana /ID# 79238 Recruiting
Fort Wayne, Indiana, United States, 46804
Indiana University /ID# 121395 Recruiting
Indianapolis, Indiana, United States, 46202
Riley Hospital for Children /ID# 78903 Recruiting
Indianapolis, Indiana, United States, 46202
United States, Iowa
University of Iowa Hospitals and Clinics /ID# 78921 Recruiting
Iowa City, Iowa, United States, 52242-1083
United States, Kansas
Kansas University Medical Center /ID# 78929 Recruiting
Kansas City, Kansas, United States, 66160
Via Christi Specialty Clinics /ID# 78946 Recruiting
Wichita, Kansas, United States, 67214
United States, Kentucky
Kentucky Clinic /ID# 78922 Recruiting
Lexington, Kentucky, United States, 40506
University of Louisville Hospital /ID# 78926 Recruiting
Louisville, Kentucky, United States, 40202
United States, Louisiana
Tulane University /ID# 78916 Recruiting
New Orleans, Louisiana, United States, 70112
Louisiana State University Health Sciences Center-Shreveport /ID# 78943 Recruiting
Shreveport, Louisiana, United States, 71103
United States, Maine
Maine Medical Center /ID# 78894 Recruiting
Portland, Maine, United States, 04102
United States, Maryland
The Johns Hopkins University Hospital /ID# 78893 Recruiting
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Tufts-New England Medical Center /ID# 79254 Recruiting
Boston, Massachusetts, United States, 02111
Massachusetts General Hospital /ID# 78895 Recruiting
Boston, Massachusetts, United States, 02114
Boston Childrens Hospital /ID# 79276 Recruiting
Boston, Massachusetts, United States, 02115
Baystate Medical Center /ID# 103437 Recruiting
Springfield, Massachusetts, United States, 01199
UMass Memorial Medical Center /ID# 78954 Recruiting
Worcester, Massachusetts, United States, 01655
United States, Michigan
University of Michigan /ID# 99035 Recruiting
Ann Arbor, Michigan, United States, 48109-5212
Michigan State University /ID# 78950 Recruiting
East Lansing, Michigan, United States, 48823
Children's Hospital of Michigan /ID# 79278 Recruiting
Farmington Hills, Michigan, United States, 48331
Helen DeVos Childrens Hospital /ID# 79397 Recruiting
Grand Rapids, Michigan, United States, 49503
United States, Minnesota
Children's Hospital and Clinics of Minnesota /ID# 79253 Recruiting
Minneapolis, Minnesota, United States, 55404
University of Minnesota /ID# 76791 Recruiting
Minneapolis, Minnesota, United States, 55455
United States, Mississippi
University of Mississippi Medical Center /ID# 78934 Recruiting
Jackson, Mississippi, United States, 39216
United States, Missouri
University of Missouri /ID# 109755 Recruiting
Columbia, Missouri, United States, 65201
The Children's Mercy Hospital & Clinics /ID# 78948 Recruiting
Kansas City, Missouri, United States, 64108
Cardinal Glennon Children's Hospital /ID# 79275 Recruiting
Saint Louis, Missouri, United States, 63104
Children's Hospital St Louis /ID# 78910 Recruiting
Saint Louis, Missouri, United States, 63110
United States, Nebraska
University of Nebraska Medical Center /ID# 78932 Recruiting
Omaha, Nebraska, United States, 68198
United States, New Hampshire
Dartmouth-Hitchcock Medical Center /ID# 78957 Recruiting
Manchester, New Hampshire, United States, 03104
United States, New Jersey
St. Barnabas Medical Center /ID# 79258 Recruiting
Livingston, New Jersey, United States, 07039
Monmouth Medical Center /ID# 78901 Recruiting
Long Branch, New Jersey, United States, 07740
Morristown Medical Center /ID# 76782 Recruiting
Morristown, New Jersey, United States, 07960
UMDNJ - Robert Wood Johnson Medical School /ID# 119978 Recruiting
New Brunswick, New Jersey, United States, 08901
United States, New York
Albany Medical College /ID# 76774 Recruiting
Albany, New York, United States, 12208
Cystic Fibrosis Therapeutics Development Center of W.Newyork /ID# 78941 Recruiting
Buffalo, New York, United States, 14222
North Shore University Hospital /ID# 76779 Recruiting
New Hyde Park, New York, United States, 11040
Mount Sinai Beth Israel /ID# 76773 Recruiting
New York, New York, United States, 10003
Morgan Stanley Children's Hospital of NY Presbyterian /ID# 79376 Recruiting
New York, New York, United States, 10032
University of Rochester /ID# 92713 Recruiting
Rochester, New York, United States, 14642
SUNY Upstate Medical Center /ID# 78912 Recruiting
Syracuse, New York, United States, 13210
New York Medical College /ID# 78956 Recruiting
Valhalla, New York, United States, 10595
United States, North Carolina
University of North Carolina /ID# 78937 Recruiting
Chapel Hill, North Carolina, United States, 27599
Duke Cancer Center /ID# 79393 Recruiting
Durham, North Carolina, United States, 27710
United States, North Dakota
Mid Dakota Clinic, PC /ID# 78958 Recruiting
Bismarck, North Dakota, United States, 58504
United States, Ohio
Akron Childrens Hospital /ID# 79263 Recruiting
Akron, Ohio, United States, 44308
Cincinnati Children's Hospital Medical Center /ID# 79375 Recruiting
Cincinnati, Ohio, United States, 45229
University of Cincinnati /ID# 76789 Recruiting
Cincinnati, Ohio, United States, 45267-0564
Rainbow Babies and Childrens Hospital /ID# 78904 Recruiting
Cleveland, Ohio, United States, 44106
Nationwide Childrens Hospital /ID# 78897 Recruiting
Columbus, Ohio, United States, 43205
The Childrens Medical Center of Dayton /ID# 78915 Recruiting
Dayton, Ohio, United States, 45404
The Toledo Hospital /ID# 78913 Recruiting
Toledo, Ohio, United States, 43606
United States, Oklahoma
University of Oklahoma Health Sciences Center /ID# 79279 Recruiting
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Kaiser Permanente, Northwest Region /ID# 79236 Recruiting
Portland, Oregon, United States, 97227
Oregon Health & Science University (OHSU) /ID# 78900 Recruiting
Portland, Oregon, United States, 97239
United States, Pennsylvania
Geisinger Medical Center /ID# 79233 Recruiting
Danville, Pennsylvania, United States, 17822-1339
Penn State Children's Hospital /ID# 79398 Recruiting
Hershey, Pennsylvania, United States, 17033
Drexel University College of Medicine /ID# 76777 Recruiting
Philadelphia, Pennsylvania, United States, 19102
Children's Hospital Philadephia /ID# 79280 Recruiting
Philadelphia, Pennsylvania, United States, 19104
St. Christopher's Hospital for Children /ID# 78908 Recruiting
Philadelphia, Pennsylvania, United States, 19134
Children's Hospital of Pittsburgh, Pennsylvania /ID# 79281 Recruiting
Pittsburgh, Pennsylvania, United States, 15224
United States, Rhode Island
Rhode Island Hospital /ID# 79274 Recruiting
Providence, Rhode Island, United States, 02903
United States, South Carolina
Medical University of South Carolina /ID# 79262 Recruiting
Charleston, South Carolina, United States, 29425
United States, South Dakota
Sanford Research/USD /ID# 78909 Recruiting
Sioux Falls, South Dakota, United States, 57104
United States, Tennessee
Children's Foundation Research Institute /ID# 78938 Recruiting
Memphis, Tennessee, United States, 38103
Vanderbilt Children's Hospital, /ID# 78947 Recruiting
Nashville, Tennessee, United States, 37212
United States, Texas
Specially for Children /ID# 79213 Recruiting
Austin, Texas, United States, 78723
UT Southwestern Medical Center /ID# 78914 Recruiting
Dallas, Texas, United States, 75390-9063
Cook Children's Medical Center /ID# 78949 Recruiting
Fort Worth, Texas, United States, 76014
Baylor College of Medicine /ID# 79273 Recruiting
Houston, Texas, United States, 77030
Univ of Texas Health Science Center San Antonio /ID# 79374 Recruiting
San Antonio, Texas, United States, 78229
The University of Texas Health Science Center at Tyler /ID# 79261 Recruiting
Tyler, Texas, United States, 75708
United States, Utah
University of Utah /ID# 76794 Recruiting
Salt Lake City, Utah, United States, 84132
United States, Vermont
Fletcher Allen Health Care, Inc. /ID# 78933 Recruiting
Burlington, Vermont, United States, 05405
United States, Virginia
University of Virginia Health System /ID# 78942 Recruiting
Charlottesville, Virginia, United States, 22908
Children's Hospital of the King's Daughters /ID# 79293 Recruiting
Norfolk, Virginia, United States, 23507
Children's Hospital of Richmond at VCU /ID# 78955 Recruiting
Richmond, Virginia, United States, 23298
United States, Washington
Seattle Children's Hospital /ID# 78902 Recruiting
Seattle, Washington, United States, 98105
Pediatric Pulmonary & Allergy/Immunology Clinic /ID# 79257 Recruiting
Spokane, Washington, United States, 99204
United States, West Virginia
West Virginia University, School of Medicine /ID# 78953 Recruiting
Morgantown, West Virginia, United States, 26506
United States, Wisconsin
University of Wisconsin Hospital and Clinics /ID# 78944 Recruiting
Madison, Wisconsin, United States, 53792
Children's Hospital of Wisconsin /ID# 79294 Recruiting
Milwaukee, Wisconsin, United States, 53226
Froedtert and The Medical College of Wisconsin /ID# 76778 Recruiting
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Cystic Fibrosis Foundation Therapeutics
Digestive Care, Inc.
Janssen Research & Development, LLC
Forest Laboratories
Investigators
Study Director: Gerhard J Leitz Janssen Research & Development, LLC
  More Information

Additional Information:
Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT01652157     History of Changes
Other Study ID Numbers: CFFC-OB-11
First Submitted: July 25, 2012
First Posted: July 27, 2012
Last Update Posted: September 1, 2017
Last Verified: August 2017

Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
prospective
pancreatic insufficiency
fibrosing colonopathy
observational
pancreatic enzyme replacement therapy

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pancrelipase
Pancreatin
Gastrointestinal Agents