Ignite Creation Date:
2024-05-05 @ 11:59 PM
Last Modification Date:
2024-10-26 @ 10:43 AM
Study NCT ID:
NCT01464281
Status:
UNKNOWN
Last Update Posted:
2011-11-03
First Post:
2011-10-19
Brief Title:
A Study of Switch From Nucleotide to Peginterferon Alfa-2a in CHB Patients Achieving HBeAg Loss and HBV DNA 200IUml
Sponsor:
The Second Affiliated Hospital of Chongqing Medical University
Organization:
The Second Affiliated Hospital of Chongqing Medical University
Study Overview
Official Title:
A Randomized Multicenter Study Evaluating HBsAg Clearance in CHB Patients Achieving HBeAg Loss and HBV DNA 200copiesml on Treatment With Nucleotide Analogues and Switched to Peginterferon Alfa-2a
Status:
UNKNOWN
Status Verified Date:
2011-11
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
New Switch
Brief Summary:
A Randomized open-label multicenter study
The patients after 1-3 years NAs treatment and having achieved HBeAg loss and HBV DNA 200IUml will be switched to Pegasys for 48 or 96 weeks with a 12 weeks period of overlap with the NA for safety reasons The subjects will be randomized into 2 groups
Group 1 48-week standard treatment by Peginterferon alfa 2a 180µgweek Group 2 96-week prolonged treatment by Peginterferon alfa 2a 180µgweek
All the patients will be followed up for 48 weeks after discontinuation of the study medication
Note NAs will be stratified LAM ETV and ADV with the ratio 111
The patients after 1-3 years NAs treatment and having achieved HBeAg loss and HBV DNA 200IUml will be switched to Pegasys for 48 or 96 weeks with a 12 weeks period of overlap with the NA for safety reasons The subjects will be randomized into 2 groups
Group 1 48-week standard treatment by Peginterferon alfa 2a 180µgweek Group 2 96-week prolonged treatment by Peginterferon alfa 2a 180µgweek
All the patients will be followed up for 48 weeks after discontinuation of the study medication
Note NAs will be stratified LAM ETV and ADV with the ratio 111
Detailed Description:
eligibility criteria Men and women old of 18 to 65 years with chronic hepatitis B HBeAg positive treated with nucleoside andor nucleotide analogues for 1-2 years and with partial response HBeAg loss and HBV DNA 1000copiesml
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