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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

Description

Pancreatic enzyme replacement therapy (PERT) with pig-derived pancreatic enzyme products is the cornerstone of nutritional management of pancreatic exocrine insufficiency (PEI) due to cystic fibrosis (CF) or other conditions. Pancreatic enzymes are extracted from the pig's pancreatic tissue. The pig populations are known to harbor certain viruses, some of which may have the potential to infect humans. Therefore, the possibility of contamination of starting materials with pig viruses capable of infecting humans must be considered. While no cases of transmission of an infectious illness associated with the use of pig pancreatic extracts have been reported to date, there remains a theoretical risk for transmission of viral disease, including diseases caused by an unidentified viruses. This study will be conducted in the United States (US) to establish the prevalence for antibodies to hepatitis E virus (HEV), pig parvovirus (PPV) and porcine circovirus 2 (PCV2) in a statistically representative cross-section of the CF population taking PERTs compared with age- and geography matched unexposed control patients. Assays for antibodies to PPV and PCV2. The following information will be collected:Screening and matching of Controls log Demographic data Medical historyTransfusion history PERT history (for CF patients)Diet history (vegetarian and vegan diets), including duration History of potential exposure to pig viruses (via questionnaire):Travel to or living in regions endemic for HEV for more than 1 week, including birthplace in such regions Past and present household pets (dogs, cats, other) Past or present consumption of organ meat (liver, kidney etc), and usual frequency of consumptionOccupational exposure (e.g., butcher or pig farmer) or parental occupationalexposure Use and frequency of injectable drugs Use and frequency of dietary supplements containing organ extracts such as pancreas, liver and brain Ever resided on a farm Specific data on blood sample collection and storage This study has 80% power and two-sided 5% Type I error to identify an antibody prevalence signal associated with PERT exposure characterized by an absolute increase in the point prevalence as well as the odds ratio for a range of antibody prevalence.

Phase

N/A

Inclusion and Exclusion 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.

  • 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.

Sites

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