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

Status: Active - Enrolling.
PI: Marie Egan, MD
Contact: Catalina Guzman (203) 785-4971 catalina.guzman@yale.edu

Purpose

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 unexposed to PERT.

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 within the next 90 days; 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.

Exclusion Criteria

  • Has a porcine heart valve, a porcine-derived graft, or has had exposure to porcine-derived products (e.g., porcine-derived heparin or insulin);
  • 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.