Cell Bound Complement Activation Proteins as Markers of Liver Injury

NCT ID: NCT01025531

Last Updated: 2014-12-08

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2014-12-31

Brief 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.

Detailed 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.

Conditions

Hepatitis C

Keywords

Hepatitis C

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

patients with newly diagnosed Hepatitis C

Hepatitis C patients newly diagnosed

No interventions assigned to this group

Eligibility Criteria

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

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adeel Butt, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

UPMC

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

physician funding

Identifier Type: OTHER

Identifier Source: secondary_id

PRO08060224

Identifier Type: -

Identifier Source: org_study_id