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

Study Overview
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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.

Official Title
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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

Conditions
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Cystic Fibrosis

Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CF patients receiving PERT<br>Cystic fibrosis (CF) patients receiving pancreatic enzyme replacement therapy (PERT) | |
| Matched control patients unexposed to PERT<br>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?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pancreatic enzyme replacement therapy, antibodies, porcine viruses, epidemiology, prospective