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

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 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.

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.

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.