Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Janssen Services, LLC | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
De-identified study of Hepatitis C infection point prevalence in the inpatient setting of an inner city hospital.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hospitalized Patients | Observation only. All patients admitted to Temple University Hospital on the study day. Observational only, no intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Number of Evaluable Participants Age 50 or Older and Point Prevalence of Hepatitis C Viremia | 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 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
All patients admitted to Temple University Hospital on the study dates
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Robert Bettiker, MD | Temple University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22351712 | Background | 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. | |
| 19473706 | 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. |
Not provided
Not provided
This is a de-identified, observational only study with no intervention. Individual participant data will not be released.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Hospitalized Patients | All patients admitted to Temple University Hospital on the study day Observation only, no intervention: Hepatitis C antibody and RNA measured from leftover sera and plasma from the clinical laboratory |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Hospitalized Patients | All patients admitted to Temple University Hospital on the study day Observation only, no intervention: HCV ab and RNA measured from leftover sera and plasma from the clinical laboratory |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | percentage of total subjects | Single 24 hour period |
|
|
This was an observation only, no intervention study. There were no adverse advents due to the study.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hospitalized Patients | All patients admitted to Temple University Hospital on the study day Observation only, no intervention: HCV ab and RNA measured from leftover sera and plasma from the clinical laboratory |
Not provided
Not provided
These results may apply only to inner city, academic medical center hospitals.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert L. Bettiker, MD/MGA, Principle Investigator | Lewis Katz School of Medicine | 215.707.1982 | robert.bettiker@temple.edu |
Not provided
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
Not provided
Not provided
Not provided
Not provided
Not provided
All leftover sera and plasma will be banked at -70 degrees Celsius in a secure laboratory for potential future research activities
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 | 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 | 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 | 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 |
| 21825931 | 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. |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Participants may have selected more than one category for race/ethnicity, and thus the total in the race category is more than the total participants. | Number | participants |
|
| Region of Enrollment | Country of residence was not determined. Zip code of residence was taken from hospital records | Number | participants |
|
| h/o: HIV, Hepatitis C infection, Intravenous drug use, HCV treatment | This category only counts participants with a particular characteristic. Thus, the total number will be less than the total participants. | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| Other Pre-specified | Number of Evaluable Participants Age 50 or Older and Point Prevalence of Hepatitis C Viremia | Association between point prevalence of hepatitis C viremia and evaluable participants age 50 or older. | Number of patients with evaluable plasma | Posted | Number | participants | Single 24 hour period |
|
|
|
|
| Other Pre-specified | Number of Evaluable Patients With Hepatitis C Viremia by Gender | Association between the incidence of hepatitis C infection and gender. | Number of evaluable patients | Posted | Number | participants | Single 24 hour period |
|
|
|
|
| Other Pre-specified | Number of Patients With Hepatitis C Viremia by Race and Ethnicity | Association between the incidence of hepatitis C infection by race and ethnicity | Number of evaluable patients | Posted | Number | Participants | Single 24 hour period |
|
|
|
|
| Other Pre-specified | Association Between Evaluable Viremic Patients and Length of Stay in the Hospital | Association between hepatitis C infection and the patient's length of stay in the hospital. | Length of stay in days | Posted | Median | 95% Confidence Interval | Days | Single 24 hour period |
|
|
|
| Other Pre-specified | Number of Evaluable Patients by Prior Visits to the Health System | Number of evaluable patients with at least one prior health system visit in the past 3 years by hepatitis C viremia | Number of evaluable patients | Posted | Number | participants | Single 24 hour period |
|
|
|
|
| 0 |
| 366 |
| 0 |
| 366 |
Not provided
Not provided
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Viremic males with history of Hepatitis C |
|
| Viremic males without history of Hepatitis C |
|
| Males without viremia |
|
| Title |
|---|
| Measurements |
|---|
|
| Viremic Other/unknown |
|
| Non-viremic AA |
|
| Non-viremic white |
|
| Non-viremic Latino/a |
|
| Non-viremic other/unknown |
|
|
| Title | Measurements |
|---|---|
|
| Viremic patient, h/o HCV, no prior visit |
|
| Viremic patient, no h/o HCV, no prior visit |
|
| Non-viremic patient, no prior visit |
|