Trial Outcomes & Findings for Undiagnosed Hepatitis C Infection in an Urban Hospital (NCT NCT01957085)
NCT ID: NCT01957085
Last Updated: 2020-04-24
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
366 participants
Primary outcome timeframe
Single 24 hour period
Results posted on
2020-04-24
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
366
|
|
Overall Study
COMPLETED
|
366
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Undiagnosed Hepatitis C Infection in an Urban Hospital
Baseline characteristics by cohort
| Measure |
Hospitalized Patients
n=366 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
238 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
128 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
188 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
178 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
184 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
67 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Latino/a
|
84 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
14 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
19 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
366 participants
n=5 Participants
|
|
h/o: HIV, Hepatitis C infection, Intravenous drug use, HCV treatment
h/o Human Immunodeficiency Virus Infection
|
11 participants
n=5 Participants
|
|
h/o: HIV, Hepatitis C infection, Intravenous drug use, HCV treatment
h/o Hepatitis C Infection
|
31 participants
n=5 Participants
|
|
h/o: HIV, Hepatitis C infection, Intravenous drug use, HCV treatment
h/o intravenous drug use
|
94 participants
n=5 Participants
|
|
h/o: HIV, Hepatitis C infection, Intravenous drug use, HCV treatment
h/o Hepatitis C treatment
|
0 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Single 24 hour periodThe 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.
Outcome measures
| Measure |
Hospitalized Patients
n=366 Participants
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
|
|---|---|
|
Point Prevalence of Hepatitis C Infection
|
9 percentage of total subjects
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Single 24 hour periodPopulation: Number of patients with evaluable plasma
Association between point prevalence of hepatitis C viremia and evaluable participants age 50 or older.
Outcome measures
| Measure |
Hospitalized Patients
n=237 Participants
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
|
|---|---|
|
Number of Evaluable Participants Age 50 or Older and Point Prevalence of Hepatitis C Viremia
# viremic >=50 yrs w h/o HCV
|
15 participants
|
|
Number of Evaluable Participants Age 50 or Older and Point Prevalence of Hepatitis C Viremia
# viremic >=50 yrs w/o h/o HCV
|
9 participants
|
|
Number of Evaluable Participants Age 50 or Older and Point Prevalence of Hepatitis C Viremia
Without viremia >=50 yrs
|
213 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Single 24 hour periodPopulation: Number of evaluable patients
Association between the incidence of hepatitis C infection and gender.
Outcome measures
| Measure |
Hospitalized Patients
n=341 Participants
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
|
|---|---|
|
Number of Evaluable Patients With Hepatitis C Viremia by Gender
Viremic females with history of Hepatitis C
|
8 participants
|
|
Number of Evaluable Patients With Hepatitis C Viremia by Gender
Viremic females without a history of Hepatitis C
|
6 participants
|
|
Number of Evaluable Patients With Hepatitis C Viremia by Gender
Females without viremia
|
165 participants
|
|
Number of Evaluable Patients With Hepatitis C Viremia by Gender
Viremic males with history of Hepatitis C
|
8 participants
|
|
Number of Evaluable Patients With Hepatitis C Viremia by Gender
Viremic males without history of Hepatitis C
|
8 participants
|
|
Number of Evaluable Patients With Hepatitis C Viremia by Gender
Males without viremia
|
146 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Single 24 hour periodPopulation: Number of evaluable patients
Association between the incidence of hepatitis C infection by race and ethnicity
Outcome measures
| Measure |
Hospitalized Patients
n=341 Participants
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
|
|---|---|
|
Number of Patients With Hepatitis C Viremia by Race and Ethnicity
Viremic AA
|
14 Participants
|
|
Number of Patients With Hepatitis C Viremia by Race and Ethnicity
Viremic White
|
8 Participants
|
|
Number of Patients With Hepatitis C Viremia by Race and Ethnicity
Viremic Latino/a
|
8 Participants
|
|
Number of Patients With Hepatitis C Viremia by Race and Ethnicity
Viremic Other/unknown
|
1 Participants
|
|
Number of Patients With Hepatitis C Viremia by Race and Ethnicity
Non-viremic AA
|
156 Participants
|
|
Number of Patients With Hepatitis C Viremia by Race and Ethnicity
Non-viremic white
|
55 Participants
|
|
Number of Patients With Hepatitis C Viremia by Race and Ethnicity
Non-viremic Latino/a
|
70 Participants
|
|
Number of Patients With Hepatitis C Viremia by Race and Ethnicity
Non-viremic other/unknown
|
29 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Single 24 hour periodPopulation: Length of stay in days
Association between hepatitis C infection and the patient's length of stay in the hospital.
Outcome measures
| Measure |
Hospitalized Patients
n=341 Participants
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
|
|---|---|
|
Association Between Evaluable Viremic Patients and Length of Stay in the Hospital
Length of stay, viremic patients w h/o HCV
|
8 Days
Interval 4.0 to 12.0
|
|
Association Between Evaluable Viremic Patients and Length of Stay in the Hospital
Length of stay, viremic patients w/o h/o HCV
|
5.5 Days
Interval 0.0 to 11.5
|
|
Association Between Evaluable Viremic Patients and Length of Stay in the Hospital
Length of stay, aviremic patients
|
7 Days
Interval 6.0 to 7.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Single 24 hour periodPopulation: Number of evaluable patients
Number of evaluable patients with at least one prior health system visit in the past 3 years by hepatitis C viremia
Outcome measures
| Measure |
Hospitalized Patients
n=341 Participants
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
|
|---|---|
|
Number of Evaluable Patients by Prior Visits to the Health System
Viremic patient, h/o HCV with >= 1 prior visit
|
14 participants
|
|
Number of Evaluable Patients by Prior Visits to the Health System
Viremic patient, no h/o HCV with >=1 prior visit
|
12 participants
|
|
Number of Evaluable Patients by Prior Visits to the Health System
Non-Viremic patient, with >=1 prior visit
|
221 participants
|
|
Number of Evaluable Patients by Prior Visits to the Health System
Viremic patient, h/o HCV, no prior visit
|
2 participants
|
|
Number of Evaluable Patients by Prior Visits to the Health System
Viremic patient, no h/o HCV, no prior visit
|
2 participants
|
|
Number of Evaluable Patients by Prior Visits to the Health System
Non-viremic patient, no prior visit
|
90 participants
|
Adverse Events
Hospitalized Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Robert L. Bettiker, MD/MGA, Principle Investigator
Lewis Katz School of Medicine
Phone: 215.707.1982
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place