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Undiagnosed Hepatitis C Infection in an Urban Hospital

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01957085
Recruitment Status : Completed
First Posted : October 8, 2013
Results First Posted : April 24, 2020
Last Update Posted : April 24, 2020
Sponsor:
Collaborator:
Janssen Services, LLC
Information provided by (Responsible Party):
Temple University

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.

Condition or disease Intervention/treatment
Hepatitis C Other: observation only

Detailed Description:
De-identified study of Hepatitis C infection point prevalence in the inpatient setting of an inner city hospital.

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Study Type : Observational
Actual Enrollment : 366 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Incidence of Undiagnosed Hepatitis C Infection in an Urban Hospital
Study Start Date : June 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Hospitalized Patients
Observation only. All patients admitted to Temple University Hospital on the study day. Observational only, no intervention.
Other: observation only
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.




Primary Outcome Measures :
  1. Point Prevalence of Hepatitis C Infection [ Time Frame: Single 24 hour period ]
    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.


Other Outcome Measures:
  1. Number of Evaluable Participants Age 50 or Older and Point Prevalence of Hepatitis C Viremia [ Time Frame: Single 24 hour period ]
    Association between point prevalence of hepatitis C viremia and evaluable participants age 50 or older.

  2. Number of Evaluable Patients With Hepatitis C Viremia by Gender [ Time Frame: Single 24 hour period ]
    Association between the incidence of hepatitis C infection and gender.

  3. Number of Patients With Hepatitis C Viremia by Race and Ethnicity [ Time Frame: Single 24 hour period ]
    Association between the incidence of hepatitis C infection by race and ethnicity

  4. Association Between Evaluable Viremic Patients and Length of Stay in the Hospital [ Time Frame: Single 24 hour period ]
    Association between hepatitis C infection and the patient's length of stay in the hospital.

  5. Number of Evaluable Patients by Prior Visits to the Health System [ Time Frame: Single 24 hour period ]
    Number of evaluable patients with at least one prior health system visit in the past 3 years by hepatitis C viremia


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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All patients admitted to Temple University Hospital on the study dates
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01957085


Locations
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United States, Pennsylvania
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
Temple University
Janssen Services, LLC
Investigators
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Principal Investigator: Robert Bettiker, MD Temple University
Publications:
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Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT01957085    
Other Study ID Numbers: Undiagnosed Hepatitis C
First Posted: October 8, 2013    Key Record Dates
Results First Posted: April 24, 2020
Last Update Posted: April 24, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This is a de-identified, observational only study with no intervention. Individual participant data will not be released.
Keywords provided by Temple University:
Hepatitis C
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections