The Optimizing Treatment of PegIFN Alfa in HBeAg-negative CHB Patients With Low Level HBsAg
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|ClinicalTrials.gov Identifier: NCT02838810|
Recruitment Status : Recruiting
First Posted : July 20, 2016
Last Update Posted : February 1, 2017
|Condition or disease||Intervention/treatment||Phase|
|Chronic Hepatitis B||Drug: peginterferon alfa Drug: Nucleoside analogues||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 :||June 2016|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
CHB patients with low level HBsAg.Hepatitis B e antigen (HBeAg)-negative CHB patients who had received NAs for more than 12 months, with HBsAg <1000 IU/mL and Hepatitis B virus DNA <100 IU/mL, are to receive peginterferon alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week. The longest course of treatment is 96 weeks. After treatment, patients will be followed up for 24 weeks. During the 96 weeks course of treatment, HBsAg level will be monitored. When HBsAg level is less than 0.05 IU/mL, peginterferon treatment will be stopped and patients will receive 24 weeks follow up.
Drug: peginterferon alfa
peginterferon alfa-2b or peginterferon alfa-2a
Patients do not need to change their NAs treatment.
Drug: Nucleoside analogues
Other Name: NAs
- HBsAg Clearance [ Time Frame: 120 weeks ]Percentage of Participants with HBsAg <0.05 IU/mL.
- HBsAg Seroconversion [ Time Frame: 120 weeks ]Percentage of Participants with HBsAg <0.05 IU/mL and anti-HBsAg positive.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02838810
|Contact: Xiang Zhu, Doctoremail@example.com|
|The third affiliated hospital of Sun Yat-sen University||Recruiting|
|Guangzhou, Guangdong, China, 510630|
|Contact: Xiang Zhu, Doctor 13826452564 firstname.lastname@example.org|
|Principal Investigator:||Zhiliang Gao, Doctor||Third Affiliated Hospital, Sun Yat-Sen University|