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

Cystic Fibrosis Clinical Trial

Official title:
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

Clinical Trial Summary

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 with chronic medical conditions unexposed to PERT.

Clinical Trial Description

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 with chronic medical conditions 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01858519
Study type Observational
Source AbbVie
Contact
Status Completed
Phase
Start date August 2013
Completion date September 2016
View Details
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