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
Brief 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.
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.
Phase
N/AInclusion 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
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.