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

NCT ID: NCT01858519

Last Updated: 2020-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1310 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-08-31

Study Completion Date

2016-09-30

Brief Summary

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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

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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.

Conditions

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Cystic Fibrosis

Keywords

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pancreatic enzyme replacement therapy antibodies porcine viruses epidemiology prospective

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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CF patients receiving PERT

Cystic fibrosis (CF) patients receiving pancreatic enzyme replacement therapy (PERT)

No interventions assigned to this group

Matched control patients unexposed to PERT

Patients unexposed to pancreatic enzyme replacement therapy (PERT); matched on age and location of residence to PERT-exposed CF patients with chronic disease.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Forest Laboratories

INDUSTRY

Sponsor Role collaborator

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role collaborator

AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gerhard J Leitz, MD

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

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Site Reference ID/Investigator# 116382

Anchorage, Alaska, United States

Site Status

Site Reference ID/Investigator# 116444

Little Rock, Arkansas, United States

Site Status

Site Reference ID/Investigator# 116595

Long Beach, California, United States

Site Status

Site Reference ID/Investigator# 116855

Los Angeles, California, United States

Site Status

Site Reference ID/Investigator# 116879

Los Angeles, California, United States

Site Status

Site Reference ID/Investigator# 116448

Los Angeles, California, United States

Site Status

Site Reference ID/Investigator# 154681

Denver, Colorado, United States

Site Status

Site Reference ID/Investigator# 116441

Hartford, Connecticut, United States

Site Status

Site Reference ID/Investigator# 127584

New Haven, Connecticut, United States

Site Status

Site Reference ID/Investigator# 116440

Gainesville, Florida, United States

Site Status

Site Reference ID/Investigator# 116882

Miami, Florida, United States

Site Status

Site Reference ID/Investigator# 116277

Orlando, Florida, United States

Site Status

Site Reference ID/Investigator# 116435

Tampa, Florida, United States

Site Status

Site Reference ID/Investigator# 131935

Atlanta, Georgia, United States

Site Status

Site Reference ID/Investigator# 116452

Boise, Idaho, United States

Site Status

Site Reference ID/Investigator# 116442

Chicago, Illinois, United States

Site Status

Site Reference ID/Investigator# 116465

Maywood, Illinois, United States

Site Status

Site Reference ID/Investigator# 141881

Niles, Illinois, United States

Site Status

Site Reference ID/Investigator# 127295

Peoria, Illinois, United States

Site Status

Site Reference ID/Investigator# 116877

Indianapolis, Indiana, United States

Site Status

Site Reference ID/Investigator# 116436

Wichita, Kansas, United States

Site Status

Site Reference ID/Investigator# 136816

Louisville, Kentucky, United States

Site Status

Site Reference ID/Investigator# 116450

New Orleans, Louisiana, United States

Site Status

Site Reference ID/Investigator# 116455

Shreveport, Louisiana, United States

Site Status

Site Reference ID/Investigator# 116461

Boston, Massachusetts, United States

Site Status

Site Reference ID/Investigator# 116463

Grand Rapids, Michigan, United States

Site Status

Site Reference ID/Investigator# 116445

Jackson, Mississippi, United States

Site Status

Site Reference ID/Investigator# 116883

Omaha, Nebraska, United States

Site Status

Site Reference ID/Investigator# 116876

Buffalo, New York, United States

Site Status

Site Reference ID/Investigator# 130461

New Hyde Park, New York, United States

Site Status

Site Reference ID/Investigator# 116449

Syracuse, New York, United States

Site Status

Site Reference ID/Investigator# 116458

Cincinnati, Ohio, United States

Site Status

Site Reference ID/Investigator# 116276

Toledo, Ohio, United States

Site Status

Site Reference ID/Investigator# 116464

Oklahoma City, Oklahoma, United States

Site Status

Site Reference ID/Investigator# 116457

Hershey, Pennsylvania, United States

Site Status

Site Reference ID/Investigator# 116880

Philadelphia, Pennsylvania, United States

Site Status

Site Reference ID/Investigator# 116467

Philadelphia, Pennsylvania, United States

Site Status

Site Reference ID/Investigator# 116466

Pittsburgh, Pennsylvania, United States

Site Status

Site Reference ID/Investigator# 116462

Charleston, South Carolina, United States

Site Status

Site Reference ID/Investigator# 116453

Sioux Falls, South Dakota, United States

Site Status

Site Reference ID/Investigator# 116875

Knoxville, Tennessee, United States

Site Status

Site Reference ID/Investigator# 116856

Houston, Texas, United States

Site Status

Site Reference ID/Investigator# 116459

Tyler, Texas, United States

Site Status

Site Reference ID/Investigator# 116278

Norfolk, Virginia, United States

Site Status

Site Reference ID/Investigator# 116460

Richmond, Virginia, United States

Site Status

Site Reference ID/Investigator# 116438

Morgantown, West Virginia, United States

Site Status

Site Reference ID/Investigator# 116439

Madison, Wisconsin, United States

Site Status

Countries

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United States

Related Links

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https://www.abbvie.com/content/dam/abbvie-dotcom/clinical-trials/pancrelipase_JSPP-12-01.pdf

clinical study report synopsis

Other Identifiers

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JSPP-12-01

Identifier Type: -

Identifier Source: org_study_id