Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00291616
Status:
COMPLETED
Last Update Posted:
2011-07-21
First Post:
2006-02-13
Brief Title:
Efficacy Study of Thymosin alpha1 Pegylated Interferon-alpha2a to Treat Chronic Hepatitis B
Sponsor:
Seoul National University Hospital
Organization:
Seoul National University Hospital
Study Overview
Official Title:
A Multicenter Randomized Controlled Trial of Combination Therapy for HBeAg Positive Chronic Hepatitis B Comparing Thymosin Alpha 1 and Pegylated Interferon-alpha2a With Pegylated Interferon-alpha2a Alone
Status:
COMPLETED
Status Verified Date:
2011-07
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 purpose of this study is to determine the optimal treatment duration of antiviral therapy for chronic hepatitis B
Detailed Description:
Thymosin alpha1interferon combination therapy has been known as an effective antiviral therapy for chronic hepatitis B It is superior to interferon single therapy since the sustained viral response rate of combination therapy used to be about 70 compared with that of single interferon therapy20 Until now the combination therapy including 6-month treatment of thymosin alpha1 has been as effective as 12-month treatment of thymosin alpha1 We hypothesized that thymosin alpha1 is an immune potentiator so the shorter duration of thymosin alpha1 treatment might be as effective as the prolonged treatment duration
In detail we designed to perform this clinical study comparing the combination of pegylated interferon and thymosin alpha1 with pegylated interferon alone Total treatment duration of both parallel groups will be 12 months and the combination therapy will be lasted for the first 3 months followed by the next ongoing pegylated interferon single therapy for 9 months
In detail we designed to perform this clinical study comparing the combination of pegylated interferon and thymosin alpha1 with pegylated interferon alone Total treatment duration of both parallel groups will be 12 months and the combination therapy will be lasted for the first 3 months followed by the next ongoing pegylated interferon single therapy for 9 months
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