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

NCT01858519 | Completed

• 1 other identifier: JSPP-12-01
• Study Type: observational
• Target: 1,310
• Locations: 1 country
• Sites: 47

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.

Conditions

Cystic Fibrosis

Keywords

pancreatic enzyme replacement therapy; antibodies; porcine viruses; epidemiology; prospective

Outcome Measures

Primary Outcomes (1)

• Seroprevalence of antibodies to hepatitis E virus (HEV) and other selected porcine viruses

  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

  18 Months

Study Arms (2)

CF patients receiving PERT

Cystic fibrosis (CF) patients receiving pancreatic enzyme replacement therapy (PERT)

Matched control patients unexposed to PERT

Patients unexposed to pancreatic enzyme replacement therapy (PERT); matched on age and location of residence to PERT-exposed CF patients with chronic disease.

Eligibility Criteria

• Age: 2 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cystic fibrosis (CF) patients receiving pancreatic enzyme replacement therapy (PERT) and patients with chronic disease not receiving any PERT.

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:

• 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.

Sponsors & Collaborators

• AbbVie: lead
• Forest Laboratories: collaborator
• Janssen Research & Development, LLC: collaborator

Study Sites (47)

Site Reference ID/Investigator# 116382

Anchorage, Alaska, 99508, United States

Location

Site Reference ID/Investigator# 116444

Little Rock, Arkansas, 72202, United States

Location

Site Reference ID/Investigator# 116595

Long Beach, California, 90806, United States

Location

Site Reference ID/Investigator# 116855

Los Angeles, California, 90027, United States

Location

Site Reference ID/Investigator# 116879

Los Angeles, California, 90027, United States

Location

Site Reference ID/Investigator# 116448

Los Angeles, California, 90033, United States

Location

Site Reference ID/Investigator# 154681

Denver, Colorado, 80206-2761, United States

Location

Site Reference ID/Investigator# 116441

Hartford, Connecticut, 06106, United States

Location

Site Reference ID/Investigator# 127584

New Haven, Connecticut, 06510, United States

Location

Site Reference ID/Investigator# 116440

Gainesville, Florida, 32610, United States

Location

Site Reference ID/Investigator# 116882

Miami, Florida, 33136, United States

Location

Site Reference ID/Investigator# 116277

Orlando, Florida, 32803, United States

Location

Site Reference ID/Investigator# 116435

Tampa, Florida, 33606, United States

Location

Site Reference ID/Investigator# 131935

Atlanta, Georgia, 30125, United States

Location

Site Reference ID/Investigator# 116452

Boise, Idaho, 83712, United States

Location

Site Reference ID/Investigator# 116442

Chicago, Illinois, 60611-2291, United States

Location

Site Reference ID/Investigator# 116465

Maywood, Illinois, 60153, United States

Location

Site Reference ID/Investigator# 141881

Niles, Illinois, 60714, United States

Location

Site Reference ID/Investigator# 127295

Peoria, Illinois, 61603, United States

Location

Site Reference ID/Investigator# 116877

Indianapolis, Indiana, 46202, United States

Location

Site Reference ID/Investigator# 116436

Wichita, Kansas, 67214, United States

Location

Site Reference ID/Investigator# 136816

Louisville, Kentucky, 40202, United States

Location

Site Reference ID/Investigator# 116450

New Orleans, Louisiana, 70112, United States

Location

Site Reference ID/Investigator# 116455

Shreveport, Louisiana, 71103, United States

Location

Site Reference ID/Investigator# 116461

Boston, Massachusetts, 02115, United States

Location

Site Reference ID/Investigator# 116463

Grand Rapids, Michigan, 49503, United States

Location

Site Reference ID/Investigator# 116445

Jackson, Mississippi, 39216, United States

Location

Site Reference ID/Investigator# 116883

Omaha, Nebraska, 68198, United States

Location

Site Reference ID/Investigator# 116876

Buffalo, New York, 14222, United States

Location

Site Reference ID/Investigator# 130461

New Hyde Park, New York, 11040, United States

Location

Site Reference ID/Investigator# 116449

Syracuse, New York, 13210, United States

Location

Site Reference ID/Investigator# 116458

Cincinnati, Ohio, 45267-0564, United States

Location

Site Reference ID/Investigator# 116276

Toledo, Ohio, 43606, United States

Location

Site Reference ID/Investigator# 116464

Oklahoma City, Oklahoma, 73104, United States

Location

Site Reference ID/Investigator# 116457

Hershey, Pennsylvania, 17033, United States

Location

Site Reference ID/Investigator# 116880

Philadelphia, Pennsylvania, 19104, United States

Location

Site Reference ID/Investigator# 116467

Philadelphia, Pennsylvania, 19134, United States

Location

Site Reference ID/Investigator# 116466

Pittsburgh, Pennsylvania, 15224, United States

Location

Site Reference ID/Investigator# 116462

Charleston, South Carolina, 29425, United States

Location

Site Reference ID/Investigator# 116453

Sioux Falls, South Dakota, 57105, United States

Location

Site Reference ID/Investigator# 116875

Knoxville, Tennessee, 37916, United States

Location

Site Reference ID/Investigator# 116856

Houston, Texas, 77030, United States

Location

Site Reference ID/Investigator# 116459

Tyler, Texas, 75708, United States

Location

Site Reference ID/Investigator# 116278

Norfolk, Virginia, 23507, United States

Location

Site Reference ID/Investigator# 116460

Richmond, Virginia, 23219, United States

Location

Site Reference ID/Investigator# 116438

Morgantown, West Virginia, 26506, United States

Location

Site Reference ID/Investigator# 116439

Madison, Wisconsin, 53792, United States

Location

Related Links

• clinical study report synopsis

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum specimens for subsequent assay for antibodies to HEV and other selected porcine viruses

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Gerhard J Leitz, MD

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2013
• First Posted: May 21, 2013
• Study Start: August 1, 2013
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: December 9, 2020

Record last verified: 2020-12

Locations

US (47)