Status:
COMPLETED
Prevalence of Antibodies to Selected Porcine Viruses in Patients With Cystic Fibrosis Receiving Porcine-derived Pancreatic Enzyme Replacement Therapy
Lead Sponsor:
AbbVie
Collaborating Sponsors:
Forest Laboratories
Janssen Research & Development, LLC
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
2-99 years
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...
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-...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
1310 Patients enrolled
Trial Details
Trial ID
NCT01858519
Start Date
August 1 2013
End Date
September 1 2016
Last Update
December 9 2020
Active Locations (47)
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1
Site Reference ID/Investigator# 116382
Anchorage, Alaska, United States, 99508
2
Site Reference ID/Investigator# 116444
Little Rock, Arkansas, United States, 72202
3
Site Reference ID/Investigator# 116595
Long Beach, California, United States, 90806
4
Site Reference ID/Investigator# 116855
Los Angeles, California, United States, 90027