Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00376259
Status:
TERMINATED
Last Update Posted:
2011-06-30
First Post:
2006-09-13
Brief Title:
Study of Combination Therapy With LdT Plus Adefovir Versus Adefovir Alone
Sponsor:
Novartis
Organization:
Novartis
Study Overview
Official Title:
An Open-label Multicenter Randomized Study of Combination Therapy With Oral LDT600 Telbivudine Plus Adefovir Dipivoxil Versus Adefovir Dipivoxil Alone in HBeAg-positive Patients With Chronic Hepatitis B Who Are Lamivudine Resistant
Status:
TERMINATED
Status Verified Date:
2011-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was not completed as planned and was terminated early with agreement from the European Medicines Agency EMEA
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is being conducted to compare the safety and effectiveness of the investigational medication LdT telbivudine used in combination with adefovir dipivoxil a drug currently approved by the Food and Drug Administration FDA for the treatment of hepatitis B virus HBV versus adefovir dipivoxil used alone The results for patients taking the combination therapy will be compared to the results for patients taking adefovir alone
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