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Cell Bound Complement Activation Proteins as Markers of Liver Injury

2014-08-27 03:17:32 | BioPortfolio

Summary

Subjects who eventually undergo treatment for HCV, we will gather treatment data (start and stop dates), and repeat CB-CAP analysis at weeks 4, 12, 24 and 72 (+/- 2 week window allowed at each time point) to determine whether CB-CAPs levels predict virologic response in treated subjects. Routine laboratory data will also be collected at these time points.

Description

The investigators will recruit consecutive HCV infected subjects from the Center for Liver Diseases (CLD) at the University of Pittsburgh Medical Center (UPMC) who are scheduled to undergo a liver biopsy as part of their routine clinical care. The liver biopsies will be read concurrently by a single study pathologist who is blinded to the subjects' clinical status. At the time of liver biopsy, blood will be drawn to perform CB-CAP assays. The CB-CAP levels will be correlated with the liver biopsy result to assess their ability to predict degree of liver injury. The investigators will retrieve labs done for routine clinical care closest to the time of liver biopsy, including complete blood count, serum aminotransferase levels, and a biochemical profile.

A total of 250 subjects will be recruited for this study. Data gathered would include demographic and clinical information, risk factors for HCV, information about drug and alcohol use and anthropometric measurements (height, weight, abdominal circumference, etc.).

For the subset of subjects who are then initiated on treatment for HCV by their healthcare providers, we will gather treatment information (start date, stop date, treatment regimen and dosage, etc.) and blood will be drawn at treatment weeks 4, 12, 24 and 72 (+/- 2 week window allowed at each time point) to determine whether CB-CAPs levels predict virologic response in treated subjects. Routine laboratory data will also be collected at these time points. The +/- 2 week time window is allowed so that the blood draw can be done at a routine clinical visit.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Conditions

Hepatitis C

Location

UPMC
Pittsburgh
Pennsylvania
United States
15213

Status

Recruiting

Source

University of Pittsburgh

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:17:32-0400

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Medical and Biotech [MESH] Definitions

INFLAMMATION of the LIVER in humans due to infection by VIRUSES. There are several significant types of human viral hepatitis with infection caused by enteric-transmission (HEPATITIS A; HEPATITIS E) or blood transfusion (HEPATITIS B; HEPATITIS C; and HEPATITIS D).

A family of hepatotropic DNA viruses which contains double-stranded DNA genomes and causes hepatitis in humans and animals. There are two genera: AVIHEPADNAVIRUS and ORTHOHEPADNAVIRUS. Hepadnaviruses include HEPATITIS B VIRUS, duck hepatitis B virus (HEPATITIS B VIRUS, DUCK), heron hepatitis B virus, ground squirrel hepatitis virus, and woodchuck hepatitis B virus (HEPATITIS B VIRUS, WOODCHUCK).

A species in the genus HEPATOVIRUS containing one serotype and two strains: HUMAN HEPATITIS A VIRUS and Simian hepatitis A virus causing hepatitis in humans (HEPATITIS A) and primates, respectively.

INFLAMMATION of the LIVER in humans caused by HEPATITIS DELTA VIRUS, a defective RNA virus that can only infect HEPATITIS B patients. For its viral coating, hepatitis delta virus requires the HEPATITIS B SURFACE ANTIGENS produced by these patients. Hepatitis D can occur either concomitantly with (coinfection) or subsequent to (superinfection) hepatitis B infection. Similar to hepatitis B, it is primarily transmitted by parenteral exposure, such as transfusion of contaminated blood or blood products, but can also be transmitted via sexual or intimate personal contact.

INFLAMMATION of the LIVER in humans caused by HEPATITIS C VIRUS, a single-stranded RNA virus. Its incubation period is 30-90 days. Hepatitis C is transmitted primarily by contaminated blood parenterally, and is often associated with transfusion and intravenous drug abuse. However, in a significant number of cases, the source of hepatitis C infection is unknown.

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