Prevalence of Antibodies to Selected Porcine Viruses in Patients With Cystic Fibrosis Receiving Porcine-derived Pancreatic Enzyme Replacement Therapy
- Conditions
- Cystic Fibrosis
- Registration Number
- NCT01858519
- Lead Sponsor
- AbbVie
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1310
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Seroprevalence of antibodies to hepatitis E virus (HEV) and other selected porcine viruses 18 Months 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (47)
Site Reference ID/Investigator# 116382
🇺🇸Anchorage, Alaska, United States
Site Reference ID/Investigator# 116595
🇺🇸Long Beach, California, United States
Site Reference ID/Investigator# 116441
🇺🇸Hartford, Connecticut, United States
Site Reference ID/Investigator# 116452
🇺🇸Boise, Idaho, United States
Site Reference ID/Investigator# 116465
🇺🇸Maywood, Illinois, United States
Site Reference ID/Investigator# 116875
🇺🇸Knoxville, Tennessee, United States
Site Reference ID/Investigator# 141881
🇺🇸Niles, Illinois, United States
Site Reference ID/Investigator# 116278
🇺🇸Norfolk, Virginia, United States
Site Reference ID/Investigator# 127295
🇺🇸Peoria, Illinois, United States
Site Reference ID/Investigator# 116439
🇺🇸Madison, Wisconsin, United States
Site Reference ID/Investigator# 116438
🇺🇸Morgantown, West Virginia, United States
Site Reference ID/Investigator# 116876
🇺🇸Buffalo, New York, United States
Site Reference ID/Investigator# 116455
🇺🇸Shreveport, Louisiana, United States
Site Reference ID/Investigator# 116445
🇺🇸Jackson, Mississippi, United States
Site Reference ID/Investigator# 116457
🇺🇸Hershey, Pennsylvania, United States
Site Reference ID/Investigator# 116436
🇺🇸Wichita, Kansas, United States
Site Reference ID/Investigator# 116459
🇺🇸Tyler, Texas, United States
Site Reference ID/Investigator# 116449
🇺🇸Syracuse, New York, United States
Site Reference ID/Investigator# 116276
🇺🇸Toledo, Ohio, United States
Site Reference ID/Investigator# 116453
🇺🇸Sioux Falls, South Dakota, United States
Site Reference ID/Investigator# 116463
🇺🇸Grand Rapids, Michigan, United States
Site Reference ID/Investigator# 130461
🇺🇸New Hyde Park, New York, 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# 116442
🇺🇸Chicago, Illinois, United States
Site Reference ID/Investigator# 131935
🇺🇸Atlanta, Georgia, United States
Site Reference ID/Investigator# 116880
🇺🇸Philadelphia, Pennsylvania, United States
Site Reference ID/Investigator# 116467
🇺🇸Philadelphia, Pennsylvania, United States
Site Reference ID/Investigator# 116466
🇺🇸Pittsburgh, Pennsylvania, United States
Site Reference ID/Investigator# 116461
🇺🇸Boston, Massachusetts, United States
Site Reference ID/Investigator# 116882
🇺🇸Miami, Florida, United States
Site Reference ID/Investigator# 116856
🇺🇸Houston, Texas, United States
Site Reference ID/Investigator# 116877
🇺🇸Indianapolis, Indiana, United States
Site Reference ID/Investigator# 116458
🇺🇸Cincinnati, Ohio, United States
Site Reference ID/Investigator# 154681
🇺🇸Denver, Colorado, United States
Site Reference ID/Investigator# 116883
🇺🇸Omaha, Nebraska, United States
Site Reference ID/Investigator# 116464
🇺🇸Oklahoma City, Oklahoma, United States
Site Reference ID/Investigator# 116435
🇺🇸Tampa, Florida, United States
Site Reference ID/Investigator# 116277
🇺🇸Orlando, Florida, United States
Site Reference ID/Investigator# 136816
🇺🇸Louisville, Kentucky, 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# 116450
🇺🇸New Orleans, Louisiana, United States
Site Reference ID/Investigator# 116462
🇺🇸Charleston, South Carolina, United States
Site Reference ID/Investigator# 116460
🇺🇸Richmond, Virginia, United States
Site Reference ID/Investigator# 116444
🇺🇸Little Rock, Arkansas, United States