Ignite Creation Date:
2024-05-06 @ 3:50 AM
Last Modification Date:
2024-10-26 @ 11:39 AM
Study NCT ID:
NCT02387684
Status:
UNKNOWN
Last Update Posted:
2016-08-19
First Post:
2015-03-01
Brief Title:
Efficay of Extended Peginterferon Alpha 2a Treatment in HBeAg Negative Chronic Hepatitis B Patients
Sponsor:
Beijing Ditan Hospital
Organization:
Beijing Ditan Hospital
Study Overview
Official Title:
Efficay of Extended Peginterferon Alpha 2aPEG-IFN a-2a Treatment in HBeAg Negative Chronic Hepatitis B Patients
Status:
UNKNOWN
Status Verified Date:
2016-08
Last Known Status:
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:
None
Brief Summary:
The most important method to slow down and stop the liver disease progression in patients with chronic hepatitis B is antiviral therapy by which to achieve maintaining viral response during treatment or obtain sustained viral response after treatment The aim of the therapy with interferon is make patients obtain immune control to HBV defined as sustained viral response after treatment however most patients cant get this target after 48 weeks of interferon treatment and some patients need extended treatment in clinical practice to enhance the rate of sustained viral response or HBsAg loss occurred during treatment In this cohort study the efficacy of extended therapy of interferon in HBeAg negative chronic hepatitis B patients will be evaluated
Detailed Description:
In this cohort study the HBeAg negative chronic hepatitis B patients would be treated with peginterferon alpha 2aPEG-IFN a-2a for 96 week and followed 24 weeks after treatment Serum HBV DNA load HBsAganti-HBs level HBeAganti-HBe will be tested at enrollment and every 3 months during treatment and follow period Parameters of liver and kidney function and liver ultrasound examination will be tested with intervals 1-3 months The efficacies were evaluated by the rate of HBsAg loss during treatment and the rate of sustained viral response after treatment and follow up
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