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

December 7, 2020 updated by: AbbVie

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 with chronic medical conditions unexposed to PERT.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

1310

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Site Reference ID/Investigator# 116382
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Site Reference ID/Investigator# 116444
    • California
      • Long Beach, California, United States, 90806
        • Site Reference ID/Investigator# 116595
      • Los Angeles, California, United States, 90027
        • Site Reference ID/Investigator# 116855
      • Los Angeles, California, United States, 90027
        • Site Reference ID/Investigator# 116879
      • Los Angeles, California, United States, 90033
        • Site Reference ID/Investigator# 116448
    • Colorado
      • Denver, Colorado, United States, 80206-2761
        • Site Reference ID/Investigator# 154681
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Site Reference ID/Investigator# 116441
      • New Haven, Connecticut, United States, 06510
        • Site Reference ID/Investigator# 127584
    • Florida
      • Gainesville, Florida, United States, 32610
        • Site Reference ID/Investigator# 116440
      • Miami, Florida, United States, 33136
        • Site Reference ID/Investigator# 116882
      • Orlando, Florida, United States, 32803
        • Site Reference ID/Investigator# 116277
      • Tampa, Florida, United States, 33606
        • Site Reference ID/Investigator# 116435
    • Georgia
      • Atlanta, Georgia, United States, 30125
        • Site Reference ID/Investigator# 131935
    • Idaho
      • Boise, Idaho, United States, 83712
        • Site Reference ID/Investigator# 116452
    • Illinois
      • Chicago, Illinois, United States, 60611-2291
        • Site Reference ID/Investigator# 116442
      • Maywood, Illinois, United States, 60153
        • Site Reference ID/Investigator# 116465
      • Niles, Illinois, United States, 60714
        • Site Reference ID/Investigator# 141881
      • Peoria, Illinois, United States, 61603
        • Site Reference ID/Investigator# 127295
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Site Reference ID/Investigator# 116877
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Site Reference ID/Investigator# 116436
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Site Reference ID/Investigator# 136816
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Site Reference ID/Investigator# 116450
      • Shreveport, Louisiana, United States, 71103
        • Site Reference ID/Investigator# 116455
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Site Reference ID/Investigator# 116461
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Site Reference ID/Investigator# 116463
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Site Reference ID/Investigator# 116445
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Site Reference ID/Investigator# 116883
    • New York
      • Buffalo, New York, United States, 14222
        • Site Reference ID/Investigator# 116876
      • New Hyde Park, New York, United States, 11040
        • Site Reference ID/Investigator# 130461
      • Syracuse, New York, United States, 13210
        • Site Reference ID/Investigator# 116449
    • Ohio
      • Cincinnati, Ohio, United States, 45267-0564
        • Site Reference ID/Investigator# 116458
      • Toledo, Ohio, United States, 43606
        • Site Reference ID/Investigator# 116276
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Site Reference ID/Investigator# 116464
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Site Reference ID/Investigator# 116457
      • Philadelphia, Pennsylvania, United States, 19104
        • Site Reference ID/Investigator# 116880
      • Philadelphia, Pennsylvania, United States, 19134
        • Site Reference ID/Investigator# 116467
      • Pittsburgh, Pennsylvania, United States, 15224
        • Site Reference ID/Investigator# 116466
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Site Reference ID/Investigator# 116462
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Site Reference ID/Investigator# 116453
    • Tennessee
      • Knoxville, Tennessee, United States, 37916
        • Site Reference ID/Investigator# 116875
    • Texas
      • Houston, Texas, United States, 77030
        • Site Reference ID/Investigator# 116856
      • Tyler, Texas, United States, 75708
        • Site Reference ID/Investigator# 116459
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Site Reference ID/Investigator# 116278
      • Richmond, Virginia, United States, 23219
        • Site Reference ID/Investigator# 116460
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Site Reference ID/Investigator# 116438
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Site Reference ID/Investigator# 116439

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 99 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
CF patients receiving PERT
Cystic fibrosis (CF) patients receiving pancreatic enzyme replacement therapy (PERT)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seroprevalence of antibodies to hepatitis E virus (HEV) and other selected porcine viruses
Time Frame: 18 Months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Collaborators

Janssen Research & Development, LLC
Forest Laboratories

Investigators

  • Study Director: Gerhard J Leitz, MD, Janssen Research & Development, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

May 17, 2013

First Submitted That Met QC Criteria

May 17, 2013

First Posted (Estimate)

May 21, 2013

Study Record Updates

Last Update Posted (Actual)

December 9, 2020

Last Update Submitted That Met QC Criteria

December 7, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JSPP-12-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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