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HBsAg Loss/Seroconversion in Low Replicative Chronic HBV Infection Patients With Low Level HBsAg Treated With Peginterferon Alpha
HBsAg Loss/Seroconversion is uncommon in Low replicative chronic HBV infection patients. The purpose of this study is to investigate the ability of peginterferon alpha to achieve HBsAg loss/seroconversion therapy in Low replicative chronic HBV infection patients with Low Level HBsAg.
Low replicative chronic HBV infection patients with low Level HBsAg were enrolled in the out-patient department of 3rd Affiliated Hospital of Sun Yat-sen University. All of them were HBsAg positive and anti-HBs negative for more than 6 months with HBV DNA\<2000 IU/mL and HBsAg levels ≤1000 IU/mL. All patients did not have other liver diseases and contraindications for interferon therapy. After giving informed consent, patients were treated with weekly subcutaneous injections of alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week. The use of other immune suppressive or regulatory drugs and other antiviral drugs was prohibited during the course of the study. In this study, treatment endpoint was HBsAg loss(\<0.05 IU/mL) and anti-HBs positive(\>10 milli-International unit(mIU)/mL) defined as seroconversion. Depending on the decline of HBsAg level, treatment was either continued for a prolonged period (no more than 96 weeks) until the endpoint was achieved, or terminated in case of nonresponse. Treatment was proceeded if HBsAg level continued to decline until HBsAg seroconversion was achieved and the anti-HBs level was above 200 mIU/ml. If the patients were not willing to extend treatment, the therapy was ended at the time of HBsAg loss, or stopped without further decline of HBsAg levels.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Department of Infectious Diseases, The Third Affliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Start Date
August 1, 2016
Primary Completion Date
September 1, 2019
Completion Date
September 1, 2019
Last Updated
May 22, 2018
200
ESTIMATED participants
peginterferon alfa
DRUG
Lead Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
Collaborators
NCT06671093
NCT06885710
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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View ClinicalTrials.gov Terms and ConditionsNCT06263959