Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00371761
Status:
COMPLETED
Last Update Posted:
2017-04-06
First Post:
2006-08-31
Brief Title:
PegIntron Versus Adefovir in the Treatment of Chronic Hepatitis B CHB e Antigen Positive Patients in Taiwan P04498MK-4031-278
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
An Open-Label Randomized Comparative Study With PegIntron vs Adefovir in the Treatment of Chronic Hepatitis B CHB e Antigen Positive Patients in Taiwan
Status:
COMPLETED
Status Verified Date:
2017-03
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 is an open label randomized comparative multi-center study Subjects will be screened within 2 weeks prior to study entry to establish eligibility Subjects who meet all the selection criteria will be randomly assigned 11 to 1 once-a-week subcutaneous Pegylated interferon alfa-2b PegIntron 15 mcgkg body weight or 2 oral adefovir 10 mg daily The treatment phase will be 24 weeks for PegIntron and 48 weeks for adefovir All subjects completing the assigned treatment phase will be followed up for an additional 48 weeks for PegIntron and 24 weeks for adefovir as observation phase The primary objective is to establish the efficacy profile of PegIntron Secondary objectives are to compare the efficacy profile of PegIntron with that of adefovir compare efficacy of PegIntron in lamivudine-naïve and lamivudine-experienced subjects and to establish the safety profile of PegIntron in treating patients with hepatitis B e antigen HBeAg-positive chronic hepatitis B
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