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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 : Recruiting
First Posted : July 27, 2012
Last Update Posted : December 19, 2018
Sponsor:
Collaborators:
Cystic Fibrosis Foundation
Digestive Care, Inc.
Forest Research Institute, Inc., an Allergan affiliate
VIVUS, Inc.
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

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.

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Study Type : Observational
Estimated Enrollment : 50 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
Estimated Primary Completion Date : July 29, 2022
Estimated Study Completion Date : July 29, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

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%)




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.



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Ages Eligible for Study:   up 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

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
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Contact: Christopher Dowd 828-345-5060 cdowd@pmg-research.com
Contact: BARBRA FOGARTY 206-884-7592 barbra.fogarty@seattlechildrens.org

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Locations
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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 Arizona Cancer Ctr /ID# 78939 Recruiting
Tucson, Arizona, United States, 85719-1478
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
Ucsd /Id# 105039 Recruiting
La Jolla, California, United States, 92037
Loma Linda University /ID# 79237 Recruiting
Loma Linda, California, United States, 92354
Miller Childrens Hospital /ID# 78896 Recruiting
Long Beach, California, United States, 90806
Kaiser Permanente Regional Met /ID# 79235 Recruiting
Los Angeles, California, United States, 90027
Usc /Id# 76793 Recruiting
Los Angeles, California, United States, 90033
Children's Hosp and Res Ctr /ID# 79295 Recruiting
Oakland, California, United States, 94609
Kaiser Permanente /ID# 78899 Recruiting
Oakland, California, United States, 94611
UC Davis Comp Cancer Ctr /ID# 118935 Recruiting
Sacramento, California, United States, 95817
California Pacific Medical Ctr /ID# 76775 Recruiting
San Francisco, California, United States, 94115
Univ California, San Francisco /ID# 78925 Recruiting
San Francisco, California, United States, 94143-2204
Stanford University /ID# 95156 Recruiting
Stanford, California, United States, 94305
United States, Colorado
Univ of Colorado Cancer Center /ID# 79277 Recruiting
Aurora, Colorado, United States, 80045
National Jewish Health /ID# 76784 Recruiting
Denver, Colorado, United States, 80206
United States, Connecticut
CT Childrens Medical Ctr, US /ID# 78923 Recruiting
Hartford, Connecticut, United States, 06106
Yale University /ID# 78940 Recruiting
New Haven, Connecticut, United States, 06510
United States, Delaware
Nemours/Alfred duPont Hosp /ID# 78945 Recruiting
Wilmington, Delaware, United States, 19803
United States, District of Columbia
Children's Natl Med Ctr /ID# 79373 Recruiting
Washington, District of Columbia, United States, 20010
United States, Florida
Central FL Pulmonary Altamonte /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 Hosp /ID# 79234 Recruiting
Hollywood, Florida, United States, 33021
Nemour Child Clin FL, US /ID# 78898 Recruiting
Jacksonville, Florida, United States, 32207
Univ Miami, Miller School Medi /ID# 78927 Recruiting
Miami, Florida, United States, 33136
Nemours Children's Clinic /ID# 78917 Recruiting
Orlando, Florida, United States, 32801
Arnold Palmer Hosp Children /ID# 96075 Completed
Orlando, Florida, United States, 32806
All Children's Hospital /ID# 79264 Recruiting
Saint Petersburg, Florida, United States, 33701
United States, Georgia
Emory University Hospital /ID# 79394 Recruiting
Atlanta, Georgia, United States, 30322
Children's Healthcare Atlanta /ID# 116275 Recruiting
Atlanta, Georgia, United States, 30342
Georgia Regents University /ID# 79395 Recruiting
Augusta, Georgia, United States, 30912
United States, Idaho
St. Lukes Cystic Fibrosis Ctr /ID# 79259 Recruiting
Boise, Idaho, United States, 83712
United States, Illinois
Childrens Hospital of Chicago /ID# 79296 Recruiting
Chicago, Illinois, United States, 60611
University of Chicago /ID# 78924 Recruiting
Chicago, Illinois, United States, 60637-1443
Loyola University Medical Ctr /ID# 76780 Recruiting
Maywood, Illinois, United States, 60153
Advocate Lutheran Gen Children /ID# 76781 Recruiting
Park Ridge, Illinois, United States, 60068
OSF Saint Francis Medical Ctr /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
Indiana University /ID# 78903 Recruiting
Indianapolis, Indiana, United States, 46202
United States, Iowa
University of Iowa Hospitals /ID# 78921 Recruiting
Iowa City, Iowa, United States, 52242
United States, Kansas
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 /ID# 78926 Recruiting
Louisville, Kentucky, United States, 40202
United States, Louisiana
Tulane Univ /ID# 78916 Recruiting
New Orleans, Louisiana, United States, 70112
Louisiana State Univ HSC /ID# 78943 Recruiting
Shreveport, Louisiana, United States, 71130
United States, Maine
Maine Medical Center /ID# 78894 Recruiting
Portland, Maine, United States, 04102
United States, Maryland
Johns Hopkins University /ID# 78893 Recruiting
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Tufts-New England Medical Ctr /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 Completed
Springfield, Massachusetts, United States, 01199
UMass Memorial Medical Center /ID# 78954 Recruiting
Worcester, Massachusetts, United States, 01655
United States, Michigan
University of Michigan Hospitals /ID# 99035 Recruiting
Ann Arbor, Michigan, United States, 48109-5008
Children's Hospital of MI /ID# 79278 Recruiting
Detroit, Michigan, United States, 48201
Michigan State University /ID# 78950 Recruiting
East Lansing, Michigan, United States, 48824
Helen DeVos Childrens Hospital /ID# 79397 Recruiting
Grand Rapids, Michigan, United States, 49503
United States, Minnesota
University of Minnesota /ID# 76791 Recruiting
Minneapolis, Minnesota, United States, 55455
United States, Mississippi
Univ of Mississippi Med Ctr,US /ID# 78934 Recruiting
Jackson, Mississippi, United States, 39216-4643
United States, Missouri
University of Missouri /ID# 109755 Recruiting
Columbia, Missouri, United States, 65212
The Children's Mercy Hospital /ID# 78948 Recruiting
Kansas City, Missouri, United States, 64108
University of Kansas Health Sy /ID# 78929 Recruiting
Kansas City, Missouri, United States, 66160
Cardinal Glennon Children's Ho /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
Univ Nebraska Med Ctr /ID# 78932 Recruiting
Omaha, Nebraska, United States, 68198
United States, New Hampshire
Dartmouth-Hitchcock Med Ctr /ID# 78957 Recruiting
Lebanon, New Hampshire, United States, 03756
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
Goryeb Chidlren's Hospital /ID# 76782 Recruiting
Morristown, New Jersey, United States, 07960
Rutgers Robert Wood Johnson /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 /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
Columbia Univ Medical Center /ID# 79376 Completed
New York, New York, United States, 10032-3725
Univ Rochester Med Ctr /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
Univ NC Chapel Hill /ID# 78937 Recruiting
Chapel Hill, North Carolina, United States, 27514-4220
Duke Univ Med Ctr /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 /ID# 79375 Recruiting
Cincinnati, Ohio, United States, 45229
University of Cincinnati /ID# 76789 Recruiting
Cincinnati, Ohio, United States, 45267-0585
Case Western Reserve Univ /ID# 78904 Recruiting
Cleveland, Ohio, United States, 44106
Nationwide Childrens Hospital /ID# 78897 Recruiting
Columbus, Ohio, United States, 43205
The Childrens Medical Center /ID# 78915 Recruiting
Dayton, Ohio, United States, 45404
ProMedica Toledo Hospital /ID# 78913 Recruiting
Toledo, Ohio, United States, 43606
United States, Oklahoma
Univ Oklahoma HSC /ID# 79279 Recruiting
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Kaiser Permanente, NW /ID# 79236 Recruiting
Portland, Oregon, United States, 97227
Oregon Health and Science University /ID# 78900 Recruiting
Portland, Oregon, United States, 97239-3098
United States, Pennsylvania
Geisinger Medical Center /ID# 79233 Completed
Danville, Pennsylvania, United States, 17822
Penn State Child Hosp.Hersh,PA /ID# 79398 Recruiting
Hershey, Pennsylvania, United States, 17033
Children's Hosp Philadelphia /ID# 79280 Recruiting
Philadelphia, Pennsylvania, United States, 19104
Drexel Univ College of Med /ID# 76777 Recruiting
Philadelphia, Pennsylvania, United States, 19129
St. Christopher's Hospital /ID# 78908 Recruiting
Philadelphia, Pennsylvania, United States, 19134
Child Hosp of Pittsburgh,PA /ID# 79281 Recruiting
Pittsburgh, Pennsylvania, United States, 15213-2583
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, 57104-8805
United States, Tennessee
LeBonheur Children's Med Ctr /ID# 78938 Recruiting
Memphis, Tennessee, United States
Vanderbilt Univ Med Ctr /ID# 78947 Recruiting
Nashville, Tennessee, United States, 37232-0011
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, 75390-7208
Cook Children's Med. Center /ID# 78949 Recruiting
Fort Worth, Texas, United States, 76104
Baylor College of Medicine /ID# 79273 Recruiting
Houston, Texas, United States, 77030-2608
Univ Texas HSC San Antonio /ID# 79374 Recruiting
San Antonio, Texas, United States, 78229
The Univ Texas HSC 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, 84112-5500
United States, Vermont
University of Vermont Medical Center /ID# 78933 Recruiting
Burlington, Vermont, United States, 05401-1473
United States, Virginia
University of Virginia /ID# 78942 Recruiting
Charlottesville, Virginia, United States, 22908
Child Hosp of the King's Dtr's /ID# 79293 Recruiting
Norfolk, Virginia, United States, 23507
Children's Hospital of Richmon /ID# 78955 Recruiting
Richmond, Virginia, United States, 23298
United States, Washington
Seattle Children's Hospital /ID# 78902 Recruiting
Seattle, Washington, United States, 98105
Arthritis Northwest, PLLC /ID# 79257 Recruiting
Spokane, Washington, United States, 99204-2336
United States, West Virginia
West Virginia Univ School Med /ID# 78953 Recruiting
Morgantown, West Virginia, United States, 26506
United States, Wisconsin
Univ of Wisconsin Hosp/Clinics /ID# 78944 Recruiting
Madison, Wisconsin, United States, 53792-0001
Froedtert and Medical College /ID# 76778 Recruiting
Milwaukee, Wisconsin, United States, 53226-3522
Children's Hospital Wisconsin /ID# 79294 Recruiting
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Cystic Fibrosis Foundation
Digestive Care, Inc.
Forest Research Institute, Inc., an Allergan affiliate
VIVUS, Inc.
Investigators
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Study Director: Craig Peterson VIVUS, Inc.

Additional Information:
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Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT01652157     History of Changes
Other Study ID Numbers: CFFC-OB-11
First Posted: July 27, 2012    Key Record Dates
Last Update Posted: December 19, 2018
Last Verified: December 2018
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 ( AbbVie (prior sponsor, Abbott) ):
prospective
observational
pancreatic insufficiency
pancreatic enzyme replacement therapy
fibrosing colonopathy
patients with cystic fibrosis

Additional relevant MeSH terms:
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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