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

Study Identifier
JSPP-12-01
CT.gov Identifier
NCT01858519
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Scientific Result Summary
Available Language(s): English
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Study Details

Medical Condition
  • Cystic Fibrosis
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    2 - 99 Years
    Inclusion and Exclusion 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.

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    Site Reference ID/Investigator# 116382
    Anchorage, Alaska, United States, 99508
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 116444
    Little Rock, Arkansas, United States, 72202
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 116595
    Long Beach, California, United States, 90806
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 116855
    Los Angeles, California, United States, 90027
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 116879
    Los Angeles, California, United States, 90027
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 116448
    Los Angeles, California, United States, 90033
    Status
    Not applicable
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