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

Completed

Conditions studied: Cystic Fibrosis

In brief

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.

Key facts

Study ID

NCT01858519

Run by

AbbVie

People needed

1310

Starts

2013-08-01

Expected to finish

2016-09-01

Last updated by the study team

2020-12-09

Who can join

Age: 2 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Site Reference ID/Investigator# 116382 — Anchorage, Alaska, United States
• Site Reference ID/Investigator# 116444 — Little Rock, Arkansas, United States
• Site Reference ID/Investigator# 116595 — Long Beach, California, United States
• Site Reference ID/Investigator# 116855 — Los Angeles, California, United States
• Site Reference ID/Investigator# 116879 — Los Angeles, California, United States
• Site Reference ID/Investigator# 116448 — Los Angeles, California, United States
• Site Reference ID/Investigator# 154681 — Denver, Colorado, United States
• Site Reference ID/Investigator# 116441 — Hartford, Connecticut, United States
• Site Reference ID/Investigator# 127584 — New Haven, Connecticut, United States
• Site Reference ID/Investigator# 116440 — Gainesville, Florida, United States
• Site Reference ID/Investigator# 116882 — Miami, Florida, United States
• Site Reference ID/Investigator# 116277 — Orlando, Florida, United States
• Site Reference ID/Investigator# 116435 — Tampa, Florida, United States
• Site Reference ID/Investigator# 131935 — Atlanta, Georgia, United States
• Site Reference ID/Investigator# 116452 — Boise, Idaho, United States
• Site Reference ID/Investigator# 116442 — Chicago, Illinois, United States
• Site Reference ID/Investigator# 116465 — Maywood, Illinois, United States
• Site Reference ID/Investigator# 141881 — Niles, Illinois, United States
• Site Reference ID/Investigator# 127295 — Peoria, Illinois, United States
• Site Reference ID/Investigator# 116877 — Indianapolis, Indiana, United States
• Site Reference ID/Investigator# 116436 — Wichita, Kansas, United States
• Site Reference ID/Investigator# 136816 — Louisville, Kentucky, United States
• Site Reference ID/Investigator# 116450 — New Orleans, Louisiana, United States
• Site Reference ID/Investigator# 116455 — Shreveport, Louisiana, United States
• Site Reference ID/Investigator# 116461 — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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