Prevalence of Antibodies to Selected Porcine Viruses in Patients With Cystic Fibrosis Receiving Porcine-derived Pancreatic Enzyme Replacement Therapy



Status:Recruiting
Conditions:Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:2 - 99
Updated:4/21/2016
Start Date:August 2013
End Date:August 2016
Contact:Ashlee Forti
Email:vtpp@registratmapi.com
Phone:877-776-0999

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A Point Prevalence Study to Evaluate the Prevalence of Antibodies to Selected Porcine Viruses in Patients With Cystic Fibrosis Who Are Receiving Porcine-Derived Pancreatic Enzyme Replacement Therapy: A Harmonized Protocol Across Sponsors

This is a point prevalence study conducted entirely in the United States (US) to establish
the prevalence of antibodies to hepatitis E virus (HEV) and other selected porcine viruses
in cystic fibrosis (CF) patients receiving pancreatic enzyme replacement therapy (PERT) for
pancreatic insufficiency compared with matched (age and region of residence) control
patients unexposed to PERT.

This is a multicenter, non-interventional point-prevalence study conducted in the US to
determine the seroprevalence of antibodies to selected porcine viruses in pancreatic enzyme
replacement therapy-exposed CF patients and in an unexposed control group matched for age
and geographic region of residence. Data collection includes demographic and medical
history, pancreatic enzyme replacement therapy, transfusion history, and history of
potential exposure to pig viruses. If a patient meets all the requirements of the study and
provides a study specific informed consent/assent, a single blood sample is obtained as part
of a planned standard-of-care blood collection.

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

Inclusion Criteria:

All Patients (PERT-exposed and unexposed controls) must meet the following criteria:

- Have a blood draw planned as part of their standard of care following enrollment into
the study; and

- Provide informed consent/assent.

Patients in the PERT-Exposed Group must meet the following criteria:

- Have been diagnosed with CF; and

- Have received PERT for a minimum of 6 months.

Patients in the Unexposed Control Group must meet the following criteria:

- Be under medical management for chronic disease;

- Never received any PERT product; and

- Match an enrolled PERT-exposed patient based on age and region-of-residence.

Exclusion Criteria:

- Has a porcine heart valve, a porcine-derived graft, or has had exposure to porcine
derived insulin. This exclusion does not apply to previous porcine-derived heparin
exposure. ;

- Refuses blood collection; or

- Has any condition that, in the opinion of the investigator, would make participation
not be in the best interest (e.g., compromise the well-being) of the patient or that
could prevent, limit, or confound the protocol-specified assessments.
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Indianapolis, Indiana 46202
Principal Investigator: Site Reference ID/Investigator# 116877, MD
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Anchorage, Alaska
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Boise, Idaho 83712
Principal Investigator: Site Reference ID/Investigator# 116452, MD
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Boston, Massachusetts
Principal Investigator: Site Reference ID/Investigator# 116461, MD
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Charleston, South Carolina 29412
Principal Investigator: Site Reference ID/Investigator# 116462, MD
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Chicago, Illinois
Principal Investigator: Site Reference ID/Investigator# 116442, MD
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Cincinnati, Ohio
Principal Investigator: Site Reference ID/Investigator# 116458, MD
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Cleveland, Ohio
Principal Investigator: Site Reference ID/Investigator# 116881, MD
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Hatford, Connecticut 06106
Principal Investigator: Site Reference ID/Investigator# 116441, MD
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Hershey, Pennsylvania 17033
Principal Investigator: Site Reference ID/Investigator# 116457, MD
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Houston, Texas
Principal Investigator: Site Reference ID/Investigator# 116856, MD
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Jackson, Mississippi 39216
Principal Investigator: Site Reference ID/Investigator# 116445, MD
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Principal Investigator: Site Reference ID/Investigator# 116444, MD
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Long Beach, California 90806
Principal Investigator: Site Reference ID/Investigator# 116595, MD
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Maywood, Illinois 60153
Principal Investigator: Site Reference ID/Investigator# 116465, MD
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Miami, Florida 33136
Principal Investigator: Site Reference ID/Investigator# 116882, MD
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Morgantown, West Virginia
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New Haven, Connecticut
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New Hyde Park, New York 11040
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New Orleans, Louisiana
Principal Investigator: Site Reference ID/Investigator# 116450, MD
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Niles, Illinois 60714
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Norfolk, Virginia 23507
Principal Investigator: Site Reference ID/Investigator# 116278, MD
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Oklahoma City, Oklahoma
Principal Investigator: Site Reference ID/Investigator# 116464, MD
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Omaha, Nebraska
Principal Investigator: Site Reference ID/Investigator# 116883, MD
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Orlando, Florida 32804
Principal Investigator: Site Reference ID/Investigator# 116277, MD
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Peoria, Illinois 61603
Principal Investigator: Site Reference ID/Investigator# 127295, MD
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Philadelphia, Pennsylvania
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Richmond, Virginia 23227
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Shreveport, Louisiana 71103
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Sioux Falls, South Dakota
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Syracuse, New York 13202
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Tampa, Florida
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Tyler, Texas 75702
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Wichita, Kansas 67214
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