HBsAg Loss/Seroconversion in Low Replicative Chronic Hepatitis B Virus(HBV) Infection Patients
|Study Design:||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||HBsAg Loss/Seroconversion in Low Replicative Chronic HBV Infection Patients With Low Level HBsAg Treated With Peginterferon Alpha|
- HBsAg Clearance Rate [ Time Frame: 96 weeks ]Percentage of Participants with HBsAg negative.
- HBsAg Seroconversion Rate [ Time Frame: 96 weeks ]Percentage of Participants with HBsAg negative and anti-HBsAg positive
|Study Start Date:||August 2016|
|Estimated Study Completion Date:||September 2018|
|Estimated Primary Completion Date:||September 2017 (Final data collection date for primary outcome measure)|
Experimental: Pegylated interferon group
Low replicative chronic HBV infection patients with HBsAg <1000 IU/ mL and HBV DNA<2000 IU/mL are to receive peginterferon alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week for at most 96 weeks.
Drug: peginterferon alfa
peginterferon alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week, for at most 96 weeks.
Other Name: peginterferon alfa-2a or peginterferon alfa-2b
No Intervention: Observing Group
Only observing and following up in this group.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02908763
|Department of Infectious Diseases, The Third Affliated Hospital of Sun Yat-sen University||Recruiting|
|Guangzhou, Guangdong, China, 510630|
|Contact: Zhi-Liang Gao, Professor 86-20-85252373 firstname.lastname@example.org|
|Contact: Xiang Zhu, Doctor 86-20-85252372 email@example.com|
|Principal Investigator: Zhi-Liang Gao, Professor|