Undiagnosed Hepatitis C Infection in an Urban Hospital

NCT01957085 | Completed Results

• 1 other identifier: Undiagnosed Hepatitis C
• Study Type: observational
• Target: 366
• Locations: 1 country
• Sites: 1

Brief Summary

The Centers for Disease Control and Prevention estimates that there are approximately 3.2 million people in the United States infected with hepatitis C and a significant percentage of these patients are unaware of their diagnosis. This study will attempt to determine the point prevalence of undiagnosed hepatitis C infection in an urban hospital population. All patients admitted to the hospital on two separate days will have hepatitis C testing done on leftover serum and plasma that was collected as part of routine inpatient lab work. Our primary goal is to determine the number of undiagnosed hepatitis C infected patients in our hospitalized population. We will also compare these rates to specific demographic characteristics, such as age, race, gender, zip code and type of insurance to see if any associations exist between these demographics and undiagnosed hepatitis C infection.

Conditions

Hepatitis C

Keywords

Hepatitis C

Outcome Measures

Primary Outcomes (1)

• Point Prevalence of Hepatitis C Infection

  The point prevalence of hepatitis C infection in our hospitalized patients will be measured on a single day. All leftover plasma/serum samples will be de-identified and tested for hepatitis C antibody and if antibody positive will be tested for hepatitis C polymerase chain reaction. Results reported as percentage of subjects who are viremic.

  Single 24 hour period

Other Outcomes (5)

• Number of Evaluable Participants Age 50 or Older and Point Prevalence of Hepatitis C Viremia

  Single 24 hour period

• Number of Evaluable Patients With Hepatitis C Viremia by Gender

  Single 24 hour period

• Number of Patients With Hepatitis C Viremia by Race and Ethnicity

  Single 24 hour period

Study Arms (1)

Hospitalized Patients

Observation only. All patients admitted to Temple University Hospital on the study day. Observational only, no intervention.

Other: observation only

Interventions

observation only OTHER

This is an observational only, nonintervention study. There will be no patient contact. This was a de-identified point prevalence study of hepatitis C infection in hospitalized patients in an inner city hospital.

Hospitalized Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients admitted to Temple University Hospital on the study dates

You may qualify if:

• Patient admitted to Temple University Hospital on either of the study dates

You may not qualify if:

• Patients admitted on both study dates will only be counted once

Sponsors & Collaborators

• Temple University: lead
• Janssen Services, LLC: collaborator

Study Sites (1)

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Related Publications (3)

• Ly KN, Xing J, Klevens RM, Jiles RB, Ward JW, Holmberg SD. The increasing burden of mortality from viral hepatitis in the United States between 1999 and 2007. Ann Intern Med. 2012 Feb 21;156(4):271-8. doi: 10.7326/0003-4819-156-4-201202210-00004.

  PMID: 22351712 BACKGROUND

• Brady KA, Weiner M, Turner BJ. Undiagnosed hepatitis C on the general medicine and trauma services of two urban hospitals. J Infect. 2009 Jul;59(1):62-9. doi: 10.1016/j.jinf.2009.04.008. Epub 2009 May 3.

  PMID: 19473706 BACKGROUND

• Seamon MJ, Ginwalla R, Kulp H, Patel J, Pathak AS, Santora TA, Gaughan JP, Goldberg AJ, Tedaldi EM. HIV and hepatitis in an urban penetrating trauma population: unrecognized and untreated. J Trauma. 2011 Aug;71(2):306-10; discussion 311. doi: 10.1097/TA.0b013e31822178bd.

  PMID: 21825931 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

All leftover sera and plasma will be banked at -70 degrees Celsius in a secure laboratory for potential future research activities

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Limitations and Caveats

These results may apply only to inner city, academic medical center hospitals.

Results Point of Contact

• Title: Robert L. Bettiker, MD/MGA, Principle Investigator
• Organization: Lewis Katz School of Medicine

robert.bettiker@temple.edu

215.707.1982

Study Officials

• Robert Bettiker, MD

  Temple University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2013
• First Posted: October 8, 2013
• Study Start: June 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2016
• Last Updated: April 24, 2020
• Results First Posted: April 24, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)