HBsAg Decline After Pegylated-interferon-α in e Antigen Positive Chronic Hepatitis B With Nucleoside Maintenance
|ClinicalTrials.gov Identifier: NCT01769833|
Recruitment Status : Unknown
Verified November 2014 by Pusan National University Hospital.
Recruitment status was: Active, not recruiting
First Posted : January 17, 2013
Last Update Posted : November 4, 2014
|Condition or disease||Intervention/treatment||Phase|
|Chronic Hepatitis B||Drug: PEG-interferon-Alfa-2A Drug: Nucleosides||Phase 3|
Pegylated interferon after long term NA therapy will potentiate the antiviral efficacy directly via its effect on broad antiviral activities and indirectly via activation of innate and adaptive immune responses leading to HBeAg seroconversion and eventually HBsAg loss and/or seroconversion.
This study proposes to compare the effect of 48 weeks exposure to pegylated interferon alpha vs. NA on HBeAg seroconversion and HBsAg levels in NA controlled HBeAg-positive CHB patients who have an undetectable HBV viral load at least 1 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||144 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||HBsAg Decline and HBeAg Seroconversion Following 48 Weeks Peg-interferon-α Treatment in Patients With e Antigen Positive Chronic Hepatitis B After Nucleoside Analogue Maintenance Therapy Compared to Continuing Nucleoside Analogue Treatment|
|Study Start Date :||May 2013|
|Estimated Primary Completion Date :||May 2015|
|Estimated Study Completion Date :||May 2016|
Active Comparator: PEG-interferon-alfa 2A
Pegasys ( PEG-interferon-Alfa-2A) 180mcg / subcutaneous / once-weekly
Other Name: Pegasys (PEG-interferon-Alfa-2A)
Placebo Comparator: Nucleosides
- Change in log10 HBsAg titer during antiviral therapy [ Time Frame: 48 week ]To evaluate whether pegylated-IFNα2a treatment lowers HBsAg levels and eventually leads to HBsAg loss in patients after long term NA therapy compared to continuing NA treatment.
- HBV DNA undetectability and below 400 IU/mL during antiviral therapy and follow-up [ Time Frame: 48 week, 96 week ]
- HBeAg seroconversion and loss during antiviral therapy and at end of treatment and 1 and 2 years following end of treatment [ Time Frame: 48 week, 96 week ]
- HBsAg loss and HBsAg seroconversion at end of treatment and 1 and 2 years following end of treatment [ Time Frame: 48 week, 96 week ]
- Change in log10 HBsAg titer during follow-up [ Time Frame: 48 week, 96 week ]
- Mean change in log10 HBsAg titre over time, as estimated from the area between the baseline value and the curve of log10 HBsAg titre divided by the duration of treatment [ Time Frame: 48 week ]
- effect of immune modulator therapy on the innate immune response in patients with HBeAg-positive CHB [ Time Frame: 48 week, 96 week ]To evaluate the effect of immune modulator therapy on the innate immune response in patients with HBeAg-positive CHB in whom NA treatment has resulted in undetectable viral replication.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01769833
|Korea, Republic of|
|Pusan National University Hospital|
|Busan, Korea, Republic of|
|Principal Investigator:||Jeong Heo, Dr||Pusan National University Hospital|