Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00076336
Status:
COMPLETED
Last Update Posted:
2011-09-05
First Post:
2004-01-20
Brief Title:
Telbivudine Versus Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
Randomized Double-Blind Trial of Telbivudine Versus Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis
Status:
COMPLETED
Status Verified Date:
2011-08
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:
This research study was conducted to compare the safety and effectiveness of the investigational medication LdT Telbivudine versus Lamivudine a drug currently approved by the US European and Asian Health Authorities for the treatment of Hepatitis B infection The results for patients taking LdT will be compared to results for patients taking lamivudine
Detailed Description:
Multicenter multinational randomized double-blind study designed to compare the safety and efficacy of telbivudine 600 mgday versus lamivudine 100 mgday for 104 weeks in adults with decompensated chronic hepatitis B and evidence of cirrhosis Patients were pre-stratified by screening Child-Turcotte-Pugh score CTP score 9 or 9 and ALT level within normal limits WNL or 10 x ULN to help assure similar degrees of hepatic insufficiency and liver inflammation on both treatment arms After 104 weeks of treatment participants were followed-up with for an additional 16 weeks
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