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Study Name: Porcine Viral Antibody Point Prevalence Study in People with CF Taking Pancreatic Enzymes
Study Type: Observational
Intervention Category: Not Applicable
Study Sponsor: AbbVie
Study Phase: 4
Recruitment Status: Recruiting
Study Drug(s): Not Applicable
Number of Participants Being Recruited: 1000
Single / Multi-Center: Multi-Center
STUDY BACKGROUND INFORMATION:
This is a multi-center, non-interventional point-prevalence study conducted in the US to determine the seroprevalence of antibodies to selected porcine viruses in people with CF taking pancreatic enzyme replacement therapy (PERT) and in a control group not taking PERT who are matched for age and geographic region of residence. Data collection will include demographic and medical history, PERT therapy, transfusion history, and history of potential exposure to pig viruses. If a patient meets all the requirements of the study, a single blood sample will be obtained as part of a planned blood collection as standard of care.

This harmonized protocol reflects equal sponsorship not only by the registering Sponsor, AbbVie, but also the Collaborators, Aptalis Pharma and Janssen Research & Development, LLC.
ELIGIBILITY
Age: >= 2 Years
FEV1: Not Applicable
P. aeruginosa status: Not applicable
B. cepacia status: Not applicable
Other Primary Eligibility Requirements:

Note: Detailed eligibility criteria information may be available on clinicaltrials.gov. If a specific trial listing for this trial is available, a link to the specific clinicaltrials.gov listing will be present in the "More Information" section below.
FOR MORE INFORMATION:
Sponsor Contact Information:
Trial Specific Link on ClinicalTrials.gov: http://clinicaltrials.gov/show/NCT01858519
Clinical Research Terms Glossary: Click here
PARTICIPATING SITES:
The sites listed below are currently recruiting subjects. Please note that this list generally lists either the pediatric or adult program but not both even though both programs may be recruiting subjects. Also, this list does not include sites that may be participating in the study but are not yet open for recruitment. If you are interested in this study please contact your center for more information.
AK
  • Providence Alaska Medical Center (Pediatric and Adult), Anchorage, AK, 99508
    Contact Information:
        Roberts, Vicki
        Phone: (907) 212-3299
        Email: vicki.roberts@providence.org
AR
  • Arkansas Children's Hospital (Pediatric), Little Rock, AR, 72202
    Contact Information:
        Ramsey, Lacey LeAnn
        Phone: (501) 364-2391
        Email: LRamsey@uams.edu
CA
  • Miller Children's Hospital (Pediatric), Long Beach, CA, 90801
    Contact Information:
        O'Donnell, Nan
        Phone: (562) 933-5607
        Email: nodonnell@memorialcare.org
  • Children's Hospital of Los Angeles (Pediatric), Los Angeles, CA, 90027
    Contact Information:
        Vajda, Natalie
        Phone: (323) 361-3255
        Email: nvajda@chla.usc.edu
CT
  • Central Connecticut Cystic Fibrosis Center (Pediatric), Hartford, CT, 06102
    Contact Information:
        Drapeau, Ginny
        Phone: (860) 545-9434
        Email: gdrapea@connecticutchildrens.org
  • Yale University School of Medicine (Pediatric), New Haven, CT, 06520
    Contact Information:
        Young, Jane
        Phone: (203) 785-5852
        Email: jane.young@yale.edu
FL
  • Central Florida Pulmonary Group (Adult), Orlando, FL, 32803
    Contact Information:
        Kesser, Kenneth (Bert)
        Phone: (407) 841-1100 X118
        Email: bkesser@cfpulmonary.com
  • Tampa General Hospital (Adult), Tampa, FL, 33606
    Contact Information:
        Roberson, Suzanne
        Phone: (813) 844-7179
        Email: sroberson@tgh.org
ID
  • Saint Luke's Cystic Fibrosis Center of Idaho (Pediatric), Boise, ID, 83712
    Contact Information:
        Durham, Dixie
        Phone: (208) 381-7334
        Email: durhamd@slhs.org
IL
  • Ann and Robert H. Lurie Children's Hospital of Chicago (Pediatric), Chicago, IL, 60611
    Contact Information:
        Singh, Noopur
        Phone: (312) 227-6861
        Email: nosingh@luriechildrens.org
IN
  • Indiana University (Adult), Indianapolis, IN, 46202
    Contact Information:
        Puntenney, Paula
        Phone: (317) 274-1441
        Email: ppuntenn@iu.edu
MI
  • Helen DeVos Women and Children's Center (Pediatric), Grand Rapids, MI, 49503
    Contact Information:
        Gile, Cynthia
        Phone: (616) 391-6148
        Email: Cynthia.Gile@spectrumhealth.org
NY
  • SUNY Upstate Medical University (Pediatric), Syracuse, NY, 13210
    Contact Information:
        Lindner, Donna
        Phone: (315) 464-7525
        Email: lindnerd@upstate.edu
OH
  • Toldeo Children's Hospital (Pediatric), Toledo, OH, 43606
    Contact Information:
        Houser, Kelly
        Phone: (419) 291-4630
        Email: kelly.houser@promedica.org
OK
  • Oklahoma Cystic Fibrosis Center (Pediatric), Oklahoma City, OK, 73104
    Contact Information:
        Fox, Jodie
        Phone: (405) 271-6216
        Email: Jodie-Fox@ouhsc.edu
PA
  • University of Pennsylvania Hospital (Adult), Philadelphia, PA, 19104
    Contact Information:
        Kubrak, Christina
        Phone: (267) 426-5135
        Email: kubrak@email.chop.edu
SD
  • Sanford Medical Center (Pediatric), Sioux Falls, SD, 57117
    Contact Information:
        Sandman, Carmen
        Phone: (605) 312-1033
        Email: Carmen.Sandman@SanfordHealth.org
VA
  • Virginia Commonwealth University (Pediatric), Richmond, VA, 23235
    Contact Information:
        Ward, Matthew
        Phone: (804) 628-3093
        Email: wardmt@vcu.edu
WI
  • University of Wisconsin (Pediatric), Madison, WI, 53792
    Contact Information:
        Makholm, Linda
        Phone: (608) 262-0340
        Email: Lmakholm@uwhealth.org
WV
  • West Virginia University CF Center (Pediatric and Adult), Morgantown, WV, 26505
    Contact Information:
        Collins, Sue
        Phone: (304) 293-7348
        Email: scollins@hsc.wvu.edu
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