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NCT01858519 Clinical Trial

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 Details — Status: Completed

Administrative data
NCT number NCT01858519
Other study ID # JSPP-12-01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 2013
Est. completion date September 2016

Study information
Verified date December 2020
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 1310
Est. completion date September 2016
Est. primary completion date September 2016
Accepts healthy volunteers No
Gender All
Age group 2 Years to 99 Years
Eligibility 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. - Have a blood draw planned to be performed within 180 days of the matched PERT-exposed patient blood draw. 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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Site Reference ID/Investigator# 116382 Anchorage Alaska
United States Site Reference ID/Investigator# 131935 Atlanta Georgia
United States Site Reference ID/Investigator# 116452 Boise Idaho
United States Site Reference ID/Investigator# 116461 Boston Massachusetts
United States Site Reference ID/Investigator# 116876 Buffalo New York
United States Site Reference ID/Investigator# 116462 Charleston South Carolina
United States Site Reference ID/Investigator# 116442 Chicago Illinois
United States Site Reference ID/Investigator# 116458 Cincinnati Ohio
United States Site Reference ID/Investigator# 154681 Denver Colorado
United States Site Reference ID/Investigator# 116440 Gainesville Florida
United States Site Reference ID/Investigator# 116463 Grand Rapids Michigan
United States Site Reference ID/Investigator# 116441 Hartford Connecticut
United States Site Reference ID/Investigator# 116457 Hershey Pennsylvania
United States Site Reference ID/Investigator# 116856 Houston Texas
United States Site Reference ID/Investigator# 116877 Indianapolis Indiana
United States Site Reference ID/Investigator# 116445 Jackson Mississippi
United States Site Reference ID/Investigator# 116875 Knoxville Tennessee
United States Site Reference ID/Investigator# 116444 Little Rock Arkansas
United States Site Reference ID/Investigator# 116595 Long Beach California
United States Site Reference ID/Investigator# 116448 Los Angeles California
United States Site Reference ID/Investigator# 116855 Los Angeles California
United States Site Reference ID/Investigator# 116879 Los Angeles California
United States Site Reference ID/Investigator# 136816 Louisville Kentucky
United States Site Reference ID/Investigator# 116439 Madison Wisconsin
United States Site Reference ID/Investigator# 116465 Maywood Illinois
United States Site Reference ID/Investigator# 116882 Miami Florida
United States Site Reference ID/Investigator# 116438 Morgantown West Virginia
United States Site Reference ID/Investigator# 127584 New Haven Connecticut
United States Site Reference ID/Investigator# 130461 New Hyde Park New York
United States Site Reference ID/Investigator# 116450 New Orleans Louisiana
United States Site Reference ID/Investigator# 141881 Niles Illinois
United States Site Reference ID/Investigator# 116278 Norfolk Virginia
United States Site Reference ID/Investigator# 116464 Oklahoma City Oklahoma
United States Site Reference ID/Investigator# 116883 Omaha Nebraska
United States Site Reference ID/Investigator# 116277 Orlando Florida
United States Site Reference ID/Investigator# 127295 Peoria Illinois
United States Site Reference ID/Investigator# 116467 Philadelphia Pennsylvania
United States Site Reference ID/Investigator# 116880 Philadelphia Pennsylvania
United States Site Reference ID/Investigator# 116466 Pittsburgh Pennsylvania
United States Site Reference ID/Investigator# 116460 Richmond Virginia
United States Site Reference ID/Investigator# 116455 Shreveport Louisiana
United States Site Reference ID/Investigator# 116453 Sioux Falls South Dakota
United States Site Reference ID/Investigator# 116449 Syracuse New York
United States Site Reference ID/Investigator# 116435 Tampa Florida
United States Site Reference ID/Investigator# 116276 Toledo Ohio
United States Site Reference ID/Investigator# 116459 Tyler Texas
United States Site Reference ID/Investigator# 116436 Wichita Kansas

Sponsors (3)
Lead Sponsor Collaborator
AbbVie Forest Laboratories, Janssen Research & Development, LLC

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Seroprevalence of antibodies to hepatitis E virus (HEV) and other selected porcine viruses Seroprevalence of antibodies to selected porcine viruses in cystic fibrosis (CF) patients exposed to porcine-derived pancreatic enzyme replacement therapy (PERT) compared with a 1:1 matched control group of patients with chronic disease unexposed to PERT 18 Months
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