Clinical trial NCT01858519: Prevalence of Antibodies to Selected Porcine Viruses in Patients With Cystic Fibrosis Receiving Porcine-derived Pancreatic Enzyme Replacement Therapy
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Keywords: pancreatic enzyme replacement therapy
antibodies
porcine viruses
epidemiology
prospective
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: Forest Laboratories
name: Janssen Research & Development, LLC
First posted: 2013-05-21
Enrollment: 1310
Sex: ALL
Minimum age (years): 2
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cystic fibrosis (CF) patients receiving pancreatic enzyme replacement therapy (PERT) and patients with chronic disease not receiving any PERT.

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Seroprevalence of antibodies to hepatitis E virus (HEV) and other selected porcine viruses
timeFrame: 18 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Site Reference ID/Investigator# 116382
state: Alaska
city: Little Rock
country: United States
facility: Site Reference ID/Investigator# 116444
state: Arkansas
city: Long Beach
country: United States
facility: Site Reference ID/Investigator# 116595
state: California
city: Los Angeles
country: United States
facility: Site Reference ID/Investigator# 116855
state: California
city: Los Angeles
country: United States
facility: Site Reference ID/Investigator# 116879
state: California
city: Los Angeles
country: United States
facility: Site Reference ID/Investigator# 116448
state: California
city: Denver
country: United States
facility: Site Reference ID/Investigator# 154681
state: Colorado
city: Hartford
country: United States
facility: Site Reference ID/Investigator# 116441
state: Connecticut
city: New Haven
country: United States
facility: Site Reference ID/Investigator# 127584
state: Connecticut
city: Gainesville
country: United States
facility: Site Reference ID/Investigator# 116440
state: Florida
city: Miami
country: United States
facility: Site Reference ID/Investigator# 116882
state: Florida
city: Orlando
country: United States
facility: Site Reference ID/Investigator# 116277
state: Florida
city: Tampa
country: United States
facility: Site Reference ID/Investigator# 116435
state: Florida
city: Atlanta
country: United States
facility: Site Reference ID/Investigator# 131935
state: Georgia
city: Boise
country: United States
facility: Site Reference ID/Investigator# 116452
state: Idaho
city: Chicago
country: United States
facility: Site Reference ID/Investigator# 116442
state: Illinois
city: Maywood
country: United States
facility: Site Reference ID/Investigator# 116465
state: Illinois
city: Niles
country: United States
facility: Site Reference ID/Investigator# 141881
state: Illinois
city: Peoria
country: United States
facility: Site Reference ID/Investigator# 127295
state: Illinois
city: Indianapolis
country: United States
facility: Site Reference ID/Investigator# 116877
state: Indiana
city: Wichita
country: United States
facility: Site Reference ID/Investigator# 116436
state: Kansas
city: Louisville
country: United States
facility: Site Reference ID/Investigator# 136816
state: Kentucky
city: New Orleans
country: United States
facility: Site Reference ID/Investigator# 116450
state: Louisiana
city: Shreveport
country: United States
facility: Site Reference ID/Investigator# 116455
state: Louisiana
city: Boston
country: United States
facility: Site Reference ID/Investigator# 116461
state: Massachusetts
city: Grand Rapids
country: United States
facility: Site Reference ID/Investigator# 116463
state: Michigan
city: Jackson
country: United States
facility: Site Reference ID/Investigator# 116445
state: Mississippi
city: Omaha
country: United States
facility: Site Reference ID/Investigator# 116883
state: Nebraska
city: Buffalo
country: United States
facility: Site Reference ID/Investigator# 116876
state: New York
city: New Hyde Park
country: United States
facility: Site Reference ID/Investigator# 130461
state: New York
city: Syracuse
country: United States
facility: Site Reference ID/Investigator# 116449
state: New York
city: Cincinnati
country: United States
facility: Site Reference ID/Investigator# 116458
state: Ohio
city: Toledo
country: United States
facility: Site Reference ID/Investigator# 116276
state: Ohio
city: Oklahoma City
country: United States
facility: Site Reference ID/Investigator# 116464
state: Oklahoma
city: Hershey
country: United States
facility: Site Reference ID/Investigator# 116457
state: Pennsylvania
city: Philadelphia
country: United States
facility: Site Reference ID/Investigator# 116880
state: Pennsylvania
city: Philadelphia
country: United States
facility: Site Reference ID/Investigator# 116467
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Site Reference ID/Investigator# 116466
state: Pennsylvania
city: Charleston
country: United States
facility: Site Reference ID/Investigator# 116462
state: South Carolina
city: Sioux Falls
country: United States
facility: Site Reference ID/Investigator# 116453
state: South Dakota
city: Knoxville
country: United States
facility: Site Reference ID/Investigator# 116875
state: Tennessee
city: Houston
country: United States
facility: Site Reference ID/Investigator# 116856
state: Texas
city: Tyler
country: United States
facility: Site Reference ID/Investigator# 116459
state: Texas
city: Norfolk
country: United States
facility: Site Reference ID/Investigator# 116278
state: Virginia
city: Richmond
country: United States
facility: Site Reference ID/Investigator# 116460
state: Virginia
city: Morgantown
country: United States
facility: Site Reference ID/Investigator# 116438
state: West Virginia
city: Madison
country: United States
facility: Site Reference ID/Investigator# 116439
state: Wisconsin
Study officials:
affiliation: Janssen Research & Development, LLC
name: Gerhard J Leitz, MD
role: STUDY_DIRECTOR
References: