The Optimizing Treatment of PegIFN Alfa in HBeAg-negative CHB Patients With Low Level HBsAg
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|ClinicalTrials.gov Identifier: NCT02745704|
Recruitment Status : Recruiting
First Posted : April 20, 2016
Last Update Posted : May 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Hepatitis B||Drug: Peginterferon alfa||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Optimizing Treatment of PegIFN Alfa in HBeAg-negative Chronic Hepatitis B Patients With Low Level HBsAg|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||April 2019|
Experimental: PEG-IFN group
Hepatitis B e antigen (HBeAg)-negative CHB patients who had received NAs for more than 12 months, with HBsAg <1500 IU/ mL and Hepatitis B virus DNA not detectable, are to receive peginterferon alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week for 48 weeks.
Drug: Peginterferon alfa
peginterferon alfa-2b 80 micrograms/week or peginterferon alfa-2a 180 micrograms/week
No Intervention: NAs group
Patients do not need to change their NAs treatment.
- HBsAg Clearance [ Time Frame: 72 weeks ]Percentage of Participants with HBsAg negative.
- HBsAg Seroconversion [ Time Frame: 72 weeks ]Percentage of Participants with HBsAg negative and anti-HBsAg positive.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02745704
|The third affiliated hospital of Sun Yat-sen University||Recruiting|
|Guangzhou, Guangdong, China, 510630|
|Contact: Xiang Zhu, Doctor 13826452564 email@example.com|