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

NCT01858519 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1310

Last updated 2020-12-09

No results posted yet for this study

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

Sponsors & Collaborators

  • Forest Laboratories

    collaborator INDUSTRY
  • Janssen Research & Development, LLC

    collaborator INDUSTRY
  • AbbVie

    lead INDUSTRY

Principal Investigators

  • Gerhard J Leitz, MD · Janssen Research & Development, LLC

Eligibility

Min Age
2 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2016-09-30
Completion
2016-09-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01858519 on ClinicalTrials.gov