Cell Bound Complement Activation Proteins as Markers of Liver Injury
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|ClinicalTrials.gov Identifier: NCT01025531|
Recruitment Status : Withdrawn
First Posted : December 3, 2009
Last Update Posted : December 8, 2014
|Condition or disease|
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 Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||Cell Bound Complement Activation Proteins as Markers of Liver Injury|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
patients with newly diagnosed Hepatitis C
Hepatitis C patients newly diagnosed
- Determine the association between CB-CAP levels and liver fibrosis [ Time Frame: 5 years ]
- Determine the effect of HCV treatment upon CB-CAP levels [ Time Frame: 5 years ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01025531
|United States, Pennsylvania|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Adeel Butt, MD||University of Pittsburgh|