AzTrials
AzTrials

Fibrosing ColonopathyNCT01652157

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)

An observational study of Fibrosing Colonopathy, run by AbbVie at 123 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 0 months to 99 years
Conditions the study is for
Fibrosing Colonopathy
What is being tested?
ULTRESA, PANCREAZE and CREON
How many people
17 participants
Where
123 sitesUnited States
Study dates
31 Jul 2012to 8 Apr 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 months to 99 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Cystic fibrosis patients who are active in the Cystic Fibrosis Patient Registry

Who may be able to join

  • 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

Who cannot join

  • None

Trial locations and contacts

123 sites in 1 country.

123 sites in 1 country

United States123 sites

  • Akron Childrens Hospital /ID# 79263

    Akron, Ohio, 44308

  • Albany Medical College /ID# 76774

    Albany, New York, 12208

  • Central FL Pulmonary Altamonte /ID# 76776

    Altamonte Springs, Florida, 32701

  • Alaska Medical Center /ID# 79256

    Anchorage, Alaska, 99508

  • University of Michigan Hospitals /ID# 99035

    Ann Arbor, Michigan, 48109

  • Emory University Hospital /ID# 79394

    Atlanta, Georgia, 30322

  • Children's Healthcare of Atlanta - Ferry Rd /ID# 116275

    Atlanta, Georgia, 30342-1605

  • Georgia Regents University /ID# 79395

    Augusta, Georgia, 30912

  • Univ of Colorado Cancer Center /ID# 79277

    Aurora, Colorado, 80045

  • Specially for Children /ID# 79213

    Austin, Texas, 78723

  • Johns Hopkins University /ID# 78893

    Baltimore, Maryland, 21287

  • Children's Hospital of Alabama /ID# 78920

    Birmingham, Alabama, 35233

  • Mid Dakota Clinic, PC /ID# 78958

    Bismarck, North Dakota, 58504

  • St Luke's Cystic Fibrosis Center of Idaho /ID# 79259

    Boise, Idaho, 83702

  • Tufts-New England Medical Ctr /ID# 79254

    Boston, Massachusetts, 02111

  • Massachusetts General Hospital /ID# 78895

    Boston, Massachusetts, 02114

  • Boston Childrens Hospital /ID# 79276

    Boston, Massachusetts, 02115

  • Cystic Fibrosis Therapeutics /ID# 78941

    Buffalo, New York, 14222

  • University of Vermont Medical Center /ID# 78933

    Burlington, Vermont, 05401-1473

  • Univ NC Chapel Hill /ID# 78937

    Chapel Hill, North Carolina, 27514-4220

  • Medical University of South Carolina /ID# 79262

    Charleston, South Carolina, 29425

  • University of Virginia /ID# 78942

    Charlottesville, Virginia, 22908

  • Duplicate_Childrens Hospital of Chicago /ID# 79296

    Chicago, Illinois, 60611

  • University of Chicago /ID# 78924

    Chicago, Illinois, 60637-1443

  • Cincinnati Children's Hospital /ID# 79375

    Cincinnati, Ohio, 45229

  • University of Cincinnati /ID# 76789

    Cincinnati, Ohio, 45267-0585

  • Case Western Reserve Univ /ID# 78904

    Cleveland, Ohio, 44106

  • University of Missouri /ID# 109755

    Columbia, Missouri, 65212

  • Nationwide Childrens Hospital /ID# 78897

    Columbus, Ohio, 43205

  • UT Southwestern Medical Center /ID# 78914

    Dallas, Texas, 75390-7208

  • Geisinger Medical Center /ID# 79233

    Danville, Pennsylvania, 17822

  • The Childrens Medical Center /ID# 78915

    Dayton, Ohio, 45404

  • National Jewish Health /ID# 76784

    Denver, Colorado, 80206

  • Children's Hospital of MI /ID# 79278

    Detroit, Michigan, 48201

  • Duke University Medical Center /ID# 79393

    Durham, North Carolina, 27710-3000

  • Michigan State University /ID# 78950

    East Lansing, Michigan, 48824

  • Lutheran Hospital of Indiana /ID# 79238

    Fort Wayne, Indiana, 46804

  • Cook Children's Med. Center /ID# 78949

    Fort Worth, Texas, 76104

  • University of Florida - Archer /ID# 76790

    Gainesville, Florida, 32610

  • University of Florida - Archer /ID# 78928

    Gainesville, Florida, 32610

  • Helen DeVos Childrens Hospital /ID# 79397

    Grand Rapids, Michigan, 49503

  • CT Childrens Medical Ctr, US /ID# 78923

    Hartford, Connecticut, 06106

  • Penn State Child Hosp.Hersh,PA /ID# 79398

    Hershey, Pennsylvania, 17033

  • Joe DiMaggio Children's Hospital at Memorial /ID# 79234

    Hollywood, Florida, 33021-5402

  • Baylor College of Medicine /ID# 79273

    Houston, Texas, 77030-3411

  • Indiana University /ID# 121395

    Indianapolis, Indiana, 46202

  • Indiana University /ID# 78903

    Indianapolis, Indiana, 46202

  • University of Iowa Hospitals and Clinics /ID# 78921

    Iowa City, Iowa, 52242

  • Univ of Mississippi Med Ctr,US /ID# 78934

    Jackson, Mississippi, 39216-4643

  • Nemour Child Clin FL, US /ID# 78898

    Jacksonville, Florida, 32207

  • University of Kansas Health Sy /ID# 78929

    Kansas City, Kansas, 66160-8500

  • The Children's Mercy Hospital /ID# 78948

    Kansas City, Missouri, 64108

  • Ucsd /Id# 105039

    La Jolla, California, 92093

  • Dartmouth-Hitchcock Medical Center /ID# 78957

    Lebanon, New Hampshire, 03756

  • Kentucky Clinic /ID# 78922

    Lexington, Kentucky, 40506

  • Arkansas Children's Hospital /ID# 79265

    Little Rock, Arkansas, 72202

  • University of Arkansas for Medical Sciences /ID# 76785

    Little Rock, Arkansas, 72205

  • St. Barnabas Medical Center /ID# 79258

    Livingston, New Jersey, 07039

  • Loma Linda University /ID# 79237

    Loma Linda, California, 92354

  • Miller Childrens Hospital /ID# 78896

    Long Beach, California, 90806

  • Monmouth Medical Center /ID# 78901

    Long Branch, New Jersey, 07740

  • Kaiser Permanente Regional Met /ID# 79235

    Los Angeles, California, 90027

  • Usc /Id# 76793

    Los Angeles, California, 90033

  • University of Louisville /ID# 78926

    Louisville, Kentucky, 40202

  • Univ of Wisconsin Hosp/Clinics /ID# 78944

    Madison, Wisconsin, 53792-0001

  • Loyola University Medical Ctr /ID# 76780

    Maywood, Illinois, 60153

  • LeBonheur Children's Med Ctr /ID# 78938

    Memphis, Tennessee, 38103

  • University of Miami, Miller School of Medicine /ID# 78927

    Miami, Florida, 33136

  • Froedtert & the Medical College of Wisconsin /ID# 76778

    Milwaukee, Wisconsin, 53226-3522

  • Children's Hospital Wisconsin - Milwaukee Campus /ID# 79294

    Milwaukee, Wisconsin, 53226

  • University of Minnesota /ID# 76791

    Minneapolis, Minnesota, 55455-0356

  • West Virginia Univ School Med /ID# 78953

    Morgantown, West Virginia, 26506

  • Goryeb Chidlren's Hospital /ID# 76782

    Morristown, New Jersey, 07960

  • Vanderbilt Univ Med Ctr /ID# 78947

    Nashville, Tennessee, 37232-0011

  • Rutgers Robert Wood Johnson /ID# 119978

    New Brunswick, New Jersey, 08901

  • Yale University /ID# 78940

    New Haven, Connecticut, 06510

  • North Shore University Hospital /ID# 76779

    New Hyde Park, New York, 11040

  • Tulane Univ /ID# 78916

    New Orleans, Louisiana, 70112

  • Mount Sinai Beth Israel /ID# 76773

    New York, New York, 10003

  • Columbia Univ Medical Center /ID# 79376

    New York, New York, 10032-3725

  • Child Hosp of the King's Dtr's /ID# 79293

    Norfolk, Virginia, 23507

  • Children's Hosp and Res Ctr /ID# 79295

    Oakland, California, 94609

  • Kaiser Permanente /ID# 78899

    Oakland, California, 94611

  • Univ Oklahoma HSC /ID# 79279

    Oklahoma City, Oklahoma, 73104

  • Univ Nebraska Med Ctr /ID# 78932

    Omaha, Nebraska, 68198

  • Nemours Children's Clinic /ID# 78917

    Orlando, Florida, 32801

  • Arnold Palmer Hosp Children /ID# 96075

    Orlando, Florida, 32806

  • Advocate Lutheran Gen Children /ID# 76781

    Park Ridge, Illinois, 60068

  • OSF Saint Francis Medical Ctr /ID# 78905

    Peoria, Illinois, 61603

  • Children's Hosp Philadelphia /ID# 79280

    Philadelphia, Pennsylvania, 19104

  • Drexel Univ College of Med /ID# 76777

    Philadelphia, Pennsylvania, 19129

  • St. Christopher's Hospital /ID# 78908

    Philadelphia, Pennsylvania, 19134

  • Phoenix Children's Hospital /ID# 78906

    Phoenix, Arizona, 85016-7710

  • Child Hosp of Pittsburgh,PA /ID# 79281

    Pittsburgh, Pennsylvania, 15213-2583

  • MMP Women's Health /ID# 78894

    Portland, Maine, 04102

  • Kaiser Permanente, NW /ID# 79236

    Portland, Oregon, 97227

  • Oregon Health and Science University /ID# 78900

    Portland, Oregon, 97239

  • Rhode Island Hospital /ID# 79274

    Providence, Rhode Island, 02903

  • Children's Hospital of Richmon /ID# 78955

    Richmond, Virginia, 23298

  • Univ Rochester Med Ctr /ID# 92713

    Rochester, New York, 14642

  • UC Davis Comprehensive Cancer Center - Main /ID# 118935

    Sacramento, California, 95817

  • University of Utah /ID# 76794

    Salt Lake City, Utah, 84112-5500

  • Univ Texas HSC San Antonio /ID# 79374

    San Antonio, Texas, 78229

  • California Pacific Medical Ctr /ID# 76775

    San Francisco, California, 94115

  • Univ California, San Francisco /ID# 78925

    San Francisco, California, 94143-2204

  • Seattle Children's Hospital /ID# 78902

    Seattle, Washington, 98105

  • Louisiana State Univ HSC /ID# 78943

    Shreveport, Louisiana, 71130

  • Sanford Research/USD /ID# 78909

    Sioux Falls, South Dakota, 57104-8805

  • Arthritis Northwest, PLLC /ID# 79257

    Spokane, Washington, 99204-2336

  • Baystate Medical Center /ID# 103437

    Springfield, Massachusetts, 01199

  • Cardinal Glennon Children's Ho /ID# 79275

    St Louis, Missouri, 63104

  • Children's Hospital St Louis /ID# 78910

    St Louis, Missouri, 63110

  • All Children's Hospital /ID# 79264

    St. Petersburg, Florida, 33701

  • Stanford University /ID# 95156

    Stanford, California, 94305

  • SUNY Upstate Medical University - Downtown /ID# 78912

    Syracuse, New York, 13210

  • ProMedica Toledo Hospital /ID# 78913

    Toledo, Ohio, 43606

  • University of Arizona Cancer Center - North Campus /ID# 78939

    Tucson, Arizona, 85719-1478

  • The Univ Texas HSC at Tyler /ID# 79261

    Tyler, Texas, 75708

  • New York Medical College /ID# 78956

    Valhalla, New York, 10595

  • Children's National Medical Center /ID# 79373

    Washington D.C., District of Columbia, 20010

  • Via Christi Specialty Clinics /ID# 78946

    Wichita, Kansas, 67214

  • Nemours/Alfred duPont Hospital for Children /ID# 78945

    Wilmington, Delaware, 19803

  • UMass Memorial Medical Center /ID# 78954

    Worcester, Massachusetts, 01655

Other trials in United States

About this study

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)

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.

Read the 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.

Being tested
ULTRESA, PANCREAZE, CREON, ZENPEP, other non-sponsor pancreatic enzyme replacement therapy
Keywords
prospective, observational, pancreatic insufficiency, pancreatic enzyme replacement therapy, fibrosing colonopathy, patients with cystic fibrosis
Medical subject headings
Exocrine Pancreatic Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ULTRESABiological

    Also called pancrelipase

    pancreatic enzyme replacement therapy

  • PANCREAZEBiological

    Also called pancrelipase

    pancreatic enzyme replacement therapy

  • CREONBiological

    Also called pancrelipase

    pancreatic enzyme replacement therapy

  • ZENPEPBiological

    Also called pancrelipase

    pancreatic enzyme replacement therapy

  • other non-sponsor pancreatic enzyme replacement therapyBiological

    Also called pancrelipase

    pancreatic enzyme replacement therapy

  • PERTZYEBiological

    Also called pancrelipase

    pancreatic enzyme replacement therapy

  • No pancreatic enzyme replacement therapyOther

    Cystic fibrosis patients in the cystic fibrosis registry not receiving any pancreatic enzyme replacement therapy (approximately 10%)

Study groups in NCT01652157
Study groupRoleWhat they receive
Cystic fibrosis (CF) patients in the CF Patient RegistryPatients diagnosed with cystic fibrosis at participating sites who are providing data to the Cystic Fibrosis Patient Registry
Receives: Biological: ULTRESA; Biological: PANCREAZE; Biological: CREON; Biological: ZENPEP; Biological: other non-sponsor pancreatic enzyme replacement therapy; Biological: PERTZYE; Other: No pancreatic enzyme replacement therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence rate of fibrosing colonopathy confirmed by an independent adjudication panel in patients receiving ZENPEP

    Fibrosing colonopathy is confirmed by an independent adjudication panel based on prospectively defined criteria.

    Measured: up to 10 years

  2. Incidence rate of fibrosing colonopathy confirmed by an independent adjudication panel in patients receiving ULTRESA

    Fibrosing colonopathy is confirmed by an independent adjudication panel based on prospectively defined criteria.

    Measured: up to 10 years

  3. Incidence rate of fibrosing colonopathy confirmed by an independent adjudication panel in patients receiving PERTZYE.

    Fibrosing colonopathy is confirmed by an independent adjudication panel based on prospectively defined criteria.

    Measured: up to 10 years

  4. Incidence rate of fibrosing colonopathy confirmed by an independent adjudication panel in patients receiving CREON

    Fibrosing colonopathy is confirmed by an independent adjudication panel based on prospectively defined criteria.

    Measured: up to 10 years

  5. Incidence rate of fibrosing colonopathy confirmed by an independent adjudication panel in patients receiving PANCREAZE

    Fibrosing colonopathy is confirmed by an independent adjudication panel based on prospectively defined criteria.

    Measured: up to 10 years

  6. Incidence rate of fibrosing colonopathy confirmed by an independent adjudication panel in patients not receiving pancreatic enzyme therapy.

    Fibrosing colonopathy is confirmed by an independent adjudication panel based on prospectively defined criteria.

    Measured: up to 10 years

  7. Incidence rate of fibrosing colonopathy confirmed by an independent adjudication panel in patients receiving non-sponsor pancreatic enzyme replacement therapy

    Fibrosing colonopathy is confirmed by an independent adjudication panel based on prospectively defined criteria.

    Measured: up to 10 years

Secondary outcomes (1)

  1. Odds ratio (95% confidence interval) to quantify the association between possible risk factors and confirmed fibrosing colonopathy

    Potential risk factors include demographics, medical history, and concurrent medications, including daily dosage and length of specific pancreatic enzyme replacement therapy.

    Measured: up to 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2012 (estimated)
  2. Study start31 Jul 2012
  3. Primary completion8 Apr 2020
  4. Study completion8 Apr 2020

Why it stopped: Strategic considerations

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01652157
Sponsor's protocol ID
CFFC-OB-11
Status last verified
Mar 2021
First submitted
25 Jul 2012
Last updated
22 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Chiuve SE, Fife D, Leitz G, Peterson C, Campbell NM, Rennig A, Rodrigues L Jr, Decktor D, Dowd C, Marshall BC, Borowitz D. Incidence of fibrosing colonopathy with pancreatic enzyme replacement therapy in patients with cystic fibrosis. J Cyst Fibros. 2023 Nov;22(6):1017-1023. doi: 10.1016/j.jcf.2023.08.013. Epub 2023 Oct 23.

    PubMed 37880023

Questions about this trial

What is this clinical trial studying?

An observational study of Fibrosing Colonopathy, run by AbbVie at 123 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 123 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Strategic considerations). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence rate of fibrosing colonopathy confirmed by an independent adjudication panel in patients receiving ZENPEP (time frame: up to 10 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01652157, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in