Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00059267
Status:
COMPLETED
Last Update Posted:
2017-10-18
First Post:
2003-04-22
Brief Title:
Prevention of Recurrent Hepatitis B After Liver Transplantation
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Study Overview
Official Title:
Prevention of Recurrent Hepatitis B After Liver Transplantation
Status:
COMPLETED
Status Verified Date:
2017-10
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:
Hepatitis B accounts for approximately 5000 deaths per year in the United States Liver transplantation offers the only hope for patients who develop end-stage liver disease Early results of liver transplantation for hepatitis B were poor with recurrence rate of 80 and 1-year survival of only 50 Recent studies found that preventive therapy using hepatitis B immune globulin HBIG or antiviral medications such as lamivudine can reduce the recurrence rate to roughly 30 with accompanying improvement in survival However HBIG when given as intravenous infusion in high doses is very expensive while long-term use of lamivudine is associated with drug resistance Some studies found that preventive therapy using both HBIG and lamivudine may decrease recurrence rate to less than 10 but the dose and duration of HBIG needed when used in combination with lamivudine is not clear Adefovir a new antiviral medication is effective against lamivudine resistant hepatitis B but its role in liver transplantation is uncertain because of the risk of kidney damage Many studies showed that the risk of recurrent hepatitis B is related to the viral load before transplant Thus it may be possible to tailor the preventive therapy according to the risk The aim of this study is to establish the most cost-effective preventive therapy for recurrent hepatitis B after liver transplantation
Detailed Description:
None
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 |
|---|---|---|---|
| U01DK057577 | NIH | None | httpsreporternihgovquickSearchU01DK057577 |