HBsAg Decline After Pegylated-interferon-α in e Antigen Positive Chronic Hepatitis B With Nucleoside Maintenance
Chronic Hepatitis B
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Change in log10 HBsAg titer during antiviral therapy [ Time Frame: 48 week ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- HBsAg loss and HBsAg seroconversion at end of treatment and 1 and 2 years following end of treatment [ Time Frame: 48 week, 96 week ] [ Designated as safety issue: No ]
- Change in log10 HBsAg titer during follow-up [ Time Frame: 48 week, 96 week ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- effect of immune modulator therapy on the innate immune response in patients with HBeAg-positive CHB [ Time Frame: 48 week, 96 week ] [ Designated as safety issue: No ]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.
|Study Start Date:||May 2013|
|Estimated Study Completion Date:||May 2016|
|Estimated Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01769833
|Korea, Republic of|
|Pusan National University Hospital|
|Busan, Korea, Republic of|
|Principal Investigator:||Jeong Heo, Dr||Pusan National University Hospital|