Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00338780
Status:
COMPLETED
Last Update Posted:
2006-10-29
First Post:
2006-06-19
Brief Title:
Trial of Lamivudine Treatment in HBeAg Negative Chronic Hepatitis B Patients in Asia
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
A Randomised Double-Blinded Placebo-Controlled Trial of Lamivudine Treatment in HBeAg Negative Chronic Hepatitis B Patients in Asia
Status:
COMPLETED
Status Verified Date:
2006-10
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:
The aim is to investigate whether Lamivudine 100mg daily is effective in the long term treatment of HBeAg negative chronic HBV infected patients with active liver disease in Asia
Detailed Description:
Recent studies have proved lamivudine a very potent antiviral drug in suppressing viral replication and improving hepatic necro-inflammation with minimal adverse effects in HBeAg positive chronic hepatitis B patients The efficacy of lamivudine in HBeAg positivce Asian patients has been weel established However the evidence in HBeAg negative patients is limited
In the absence of HBeAg seroconversion guidance on the clinical management of HBeAg negative hepatitis B patitents treated with lamivudine and data on the efficacy of lamivudine in controlling pre-core HBV disease long-term is still needed Existing data in HBeAg negative HBV DNA positive HBV demonstrate clear and statisticallysignificant serological benefit of lamivudine over placebo during treatment Limited sustained response was observed post-treatment following a one year treatment period Whether these results can be applied to patients in Asia is uncertain This study is therefore intended to further assess te efficacy profile over an extended treatment period in the Asian population
In the absence of HBeAg seroconversion guidance on the clinical management of HBeAg negative hepatitis B patitents treated with lamivudine and data on the efficacy of lamivudine in controlling pre-core HBV disease long-term is still needed Existing data in HBeAg negative HBV DNA positive HBV demonstrate clear and statisticallysignificant serological benefit of lamivudine over placebo during treatment Limited sustained response was observed post-treatment following a one year treatment period Whether these results can be applied to patients in Asia is uncertain This study is therefore intended to further assess te efficacy profile over an extended treatment period in the Asian population
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