- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01957085
Undiagnosed Hepatitis C Infection in an Urban Hospital
April 23, 2020 updated by: Temple University
Incidence of Undiagnosed Hepatitis C Infection in an Urban Hospital
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.
Study Overview
Detailed Description
De-identified study of Hepatitis C infection point prevalence in the inpatient setting of an inner city hospital.
Study Type
Observational
Enrollment (Actual)
366
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19140
- Temple University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All patients admitted to Temple University Hospital on the study dates
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Hospitalized Patients
Observation only.
All patients admitted to Temple University Hospital on the study day.
Observational only, no intervention.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Single 24 hour period
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Single 24 hour period
|
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.
|
Single 24 hour period
|
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
|
Single 24 hour period
|
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.
|
Single 24 hour period
|
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
|
Single 24 hour period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Robert Bettiker, MD, Temple University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. Erratum In: Ann Intern Med. 2012 Jun 5;156(11):840.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2014
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
January 1, 2016
Study Registration Dates
First Submitted
September 24, 2013
First Submitted That Met QC Criteria
October 7, 2013
First Posted (Estimate)
October 8, 2013
Study Record Updates
Last Update Posted (Actual)
April 24, 2020
Last Update Submitted That Met QC Criteria
April 23, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Undiagnosed Hepatitis C
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
This is a de-identified, observational only study with no intervention.
Individual participant data will not be released.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hepatitis C
-
Tripep ABInovio PharmaceuticalsUnknownChronic Hepatitis C Virus InfectionSweden
-
Hadassah Medical OrganizationXTL BiopharmaceuticalsWithdrawnChronic Hepatitis C Virus InfectionIsrael
-
Hadassah Medical OrganizationUnknownChronic Hepatitis C Virus InfectionIsrael
-
AbbVieCompletedChronic Hepatitis C | Hepatitis C (HCV) | Hepatitis C Genotype 1a
-
AbbVie (prior sponsor, Abbott)CompletedChronic Hepatitis C | Hepatitis C Genotype 1 | Hepatitis C (HCV)United States, Australia, Canada, France, Germany, New Zealand, Puerto Rico, Spain, United Kingdom
-
AbbVieCompletedHepatitis C Virus | Chronic Hepatitis C Virus
-
AbbVie (prior sponsor, Abbott)CompletedHepatitis C | Chronic Hepatitis C Infection | HCV | Hepatitis C Genotype 1United States
-
Trek Therapeutics, PBCCompletedChronic Hepatitis C | Hepatitis C Genotype 1 | Hepatitis C (HCV) | Hepatitis C Viral InfectionUnited States, New Zealand
-
Trek Therapeutics, PBCCompletedChronic Hepatitis C | Hepatitis C (HCV) | Hepatitis C Genotype 4 | Hepatitis C Viral InfectionUnited States
-
Beni-Suef UniversityCompletedChronic Hepatitis C Virus InfectionEgypt
Clinical Trials on observation only
-
Queen Mary University of LondonRecruiting
-
University of PennsylvaniaCompletedRespiratory Failure | CoronavirusUnited States
-
Abramson Cancer Center at Penn MedicineEnrolling by invitationLeukemia, Myeloid, Acute | Cardiotoxicity | Leukemia, Lymphoid, AcuteUnited States
-
Fondazione IRCCS Istituto Nazionale dei Tumori,...Recruiting
-
Pamela Youde Nethersole Eastern HospitalRecruiting
-
Queen Mary University of LondonRecruitingMyocardial Infarction | Coronary Microvascular Disease | GenderUnited Kingdom
-
The University of Hong KongActive, not recruitingChronic Low Back Pain | Chronic Neck PainHong Kong
-
University of PennsylvaniaCompletedFrontotemporal Degeneration | Multiple System Atrophy | Progressive Supranuclear PalsyUnited States
-
Efficacy Care R&D LtdHadassah Medical OrganizationUnknownDelirium | Delirium, Cause Unknown | Delirium of Mixed Origin | Delirium Confusional State | Delirium Drug-InducedIsrael
-
Johannes Gutenberg University MainzRecruitingEpilepsy | Dissociative Seizures | Status EpilepticusGermany