Cell Bound Complement Activation Proteins as Markers of Liver Injury
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| City: |
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Pittsburgh |
| State: |
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Pennsylvania |
| Zip Code: |
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15213 |
| Conditions: |
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Hepatitis C |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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Inclusion Criteria:
- Age 18 years of age or older at time of evaluation
- Able to give informed consent
- Confirmed HCV infection by standard antibody testing any time prior to enrollment
- Detectable HCV RNA in routine clinical testing any time prior to enrolment (since our
aim is to determine the correlation between CB-CAPs and histologic activity in
chronic HCV)
- Undergoing liver biopsy as part of their routine clinical care
Exclusion Criteria:
Any previous treatment for HCV
- Any other chronic or active liver disease that, in the opinion of the investigator,
can affect liver histology (history of alcohol use in itself will not be an exclusion
criteria)
- HIV coinfection
- Chronic Hepatitis B infection (HBsAg+ or HBeAg+ or HBV DNA+ upon last testing)
- Acute Hepatitis A infection (HAV IgM+ upon last testing)
- Use of medications that may cause increase in serum aminotransferase levels (e.g. HMG
co-A reductase inhibitors, anti-epileptics, etc.) within 30 days prior to enrollment
- Any chronic or active inflammatory disease that may potentially be associated with
higher inflammatory markers (examples include, but not limited to: tuberculosis,
inflammatory bowel disease, pneumonia, autoimmune disease)
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| NCT ID: |
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NCT01025531 |
| Primary Contact: |
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Principal Investigator
Adeel Butt, MD
University of Pittsburgh
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| Backup Contact: |
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N/A |
| Location Contact: |
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Pittsburgh, Pennsylvania 15213
United States
There is no listed contact information for this specific location.
Site Status: N/A |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 24, 2013 |
| Modifications to this listing: |
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