Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00341705
Status:
COMPLETED
Last Update Posted:
2019-12-17
First Post:
2006-06-19
Brief Title:
The Second Multicenter Hemophilia Cohort Study
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
The Second Multicenter Hemophilia Cohort Study
Status:
COMPLETED
Status Verified Date:
2013-04-02
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:
The Second Multicenter Hemophilia Cohort Study MHCS-II will evaluate and prospectively follow approximately 4500 persons with hemophilia who were exposed to hepatitis C virus HCV The vast majority will have been infected with HCV and approximately 13 will have been infected with human immunodeficiency virus HIV Primary objectives are to quantify the rates of liver decompensation hepatocellular carcinoma and non-Hodgkin lymphoma and to evaluate candidate clinical genetic virologic serologic and immunologic markers that are likely to be on the causal pathway for these conditions Candidate clinical and laboratory markers will be examined longitudinally to define changes over time and their relationships to one another Collaborative studies will focus on genome scanning and evaluation of candidate genetic loci for susceptibility or resistance to HCV and HIV infections or to the diseases that result from these infections Additional studies will identify response and complication rates of various anti-HCV and anti-HIV regimens in the setting of comprehensive clinical care of persons with hemophilia
Detailed Description:
The Second Multicenter Hemophilia Cohort Study MHCS-II will evaluate and prospectively follow approximately 4500 persons with hemophilia who were exposed to hepatitis C virus HCV The vast majority will have been infected with HCV and approximately 13 will have been infected with human immunodeficiency virus HIV Primary objectives are to quantify the rates of liver decompensation hepatocellular carcinoma and non-Hodgkin lymphoma and to evaluate candidate clinical genetic virologic serologic and immunologic markers that are likely to be on the causal pathway for these conditions Candidate clinical and laboratory markers will be examined longitudinally to define changes over time and their relationships to one another Collaborative studies will focus on genome scanning and evaluation of candidate genetic loci for susceptibility or resistance to HCV and HIV infections or to the diseases that result from these infections Additional studies will identify response and complication rates of various anti-HCV and anti-HIV regimens in the setting of comprehensive clinical care of persons with hemophilia
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 |
|---|---|---|---|
| 01-C-N170 | None | None | None |