Cell Bound Complement Activation Proteins as Markers of Liver Injury
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Cell Bound Complement Activation Proteins as Markers of Liver Injury|
- Determine the association between CB-CAP levels and liver fibrosis [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Determine the effect of HCV treatment upon CB-CAP levels [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
All biologic samples will be under the control of the principal investigator . To protect confidentiality, all personal identifiers will be removed and replaced with a specific code number. The information linking these code numbers to the corresponding subjects' identities will be kept in a separate, secure location.
|Study Start Date:||December 2008|
|Study Completion Date:||December 2014|
|Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
patients with newly diagnosed Hepatitis C
Hepatitis C patients newly diagnosed
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01025531
|United States, Pennsylvania|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Adeel Butt, MD||University of Pittsburgh|