Ignite Creation Date:
2024-05-05 @ 10:04 PM
Last Modification Date:
2024-10-26 @ 10:13 AM
Study NCT ID:
NCT01025531
Status:
WITHDRAWN
Last Update Posted:
2014-12-08
First Post:
2009-12-02
Brief Title:
Cell Bound Complement Activation Proteins as Markers of Liver Injury
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Cell Bound Complement Activation Proteins as Markers of Liver Injury
Status:
WITHDRAWN
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| physician funding | OTHER | UPMC | None |