Ignite Creation Date:
2024-05-06 @ 7:45 AM
Last Modification Date:
2024-10-26 @ 11:52 AM
Study NCT ID:
NCT02594293
Status:
COMPLETED
Last Update Posted:
2022-10-31
First Post:
2015-10-11
Brief Title:
Pegylated InterferonPeg-IFN in Reducing Relapse Rate in Patients After Discontinuation of NUC Therapy
Sponsor:
Huashan Hospital
Organization:
Huashan Hospital
Study Overview
Official Title:
A Prospective Randomized Controlled Clinical Trial to Evaluate the Role of Peg-IFN Alfa-2a in Reducing RelapSe Rate in Patients With Hepatitis B e AntigenHBeAg-nEgative Chronic Hepatitis B After Discontinuation of NUC Therapy
Status:
COMPLETED
Status Verified Date:
2022-10
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 study evaluates whether Peg-IFN alfa-2a can reduce the recurrence rate of hepatitis B in 96 weeks after nucleoside analogue NUC withdrawal
The HBV HBeAg-Negative patients who received NUC anti-virus treatment for 25 years and reached stopping rule in Chinese chronic hepatitis B prevention and treatment guidelines2010 were randomly assigned into three groups One group discontinue the NUC treatment and follow up for 96 weeksOne discontinue the NUC treatment receive Peg-IFN alfa-2a 180 μg by week for 24 weeks and follow up for 72 weeksThe other discontinue the NUC treatment receive Peg-IFN alfa-2a 180 μg by week for 48 weeks and follow up for 48 weeks
The HBV HBeAg-Negative patients who received NUC anti-virus treatment for 25 years and reached stopping rule in Chinese chronic hepatitis B prevention and treatment guidelines2010 were randomly assigned into three groups One group discontinue the NUC treatment and follow up for 96 weeksOne discontinue the NUC treatment receive Peg-IFN alfa-2a 180 μg by week for 24 weeks and follow up for 72 weeksThe other discontinue the NUC treatment receive Peg-IFN alfa-2a 180 μg by week for 48 weeks and follow up for 48 weeks
Detailed Description:
NUC is a potent inhibitor of hepatitis B viralHBV replication but long-term therapy may be required Therefore NUC resistance is an important clinical risk resulting from long-term therapy in chronic hepatitis B CHB management Discontinuation of NUC is a feasible strategy to reduce resistance However the high rate of relapse after cessation of NUC treatment in CHB patients remains a big problem NUC treatment of how to safely stop drug needs to be solved
Peg-IFN can clear HBV by direct anti-viral and immune regulation mechanisms including enhancing natural killer cell response increased cluster of differentiation 8CD8 T lymphocytes and other mechanisms to restore and enhance the immune response in patients with CHB Response to PEG-IFN is frequently sustained after a finite treatment course due to its immune modulating capacity
Peg-IFN can clear HBV by direct anti-viral and immune regulation mechanisms including enhancing natural killer cell response increased cluster of differentiation 8CD8 T lymphocytes and other mechanisms to restore and enhance the immune response in patients with CHB Response to PEG-IFN is frequently sustained after a finite treatment course due to its immune modulating capacity
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