Cell Bound Complement Activation Proteins as Markers of Liver Injury

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by University of Pittsburgh.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01025531
First received: December 2, 2009
Last updated: August 23, 2012
Last verified: August 2012
  Purpose

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.


Condition
Hepatitis C

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cell Bound Complement Activation Proteins as Markers of Liver Injury

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Determine the association between CB-CAP levels and liver fibrosis [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 200
Study Start Date: December 2008
Estimated Study Completion Date: December 2013
Groups/Cohorts
patients with newly diagnosed Hepatitis C
Hepatitis C patients newly diagnosed

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

patients who are newly diagnosed with Hepatitis C

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

  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01025531

Locations
United States, Pennsylvania
UPMC
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Adeel Butt, MD University of Pittsburgh
  More Information

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01025531     History of Changes
Other Study ID Numbers: PRO08060224, physician funding
Study First Received: December 2, 2009
Last Updated: August 23, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Hepatitis C

Additional relevant MeSH terms:
Hepatitis
Hepatitis C
Digestive System Diseases
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 20, 2014