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A Follow-up Study of Peginterferon Alfa-2b Combined With TDF in Patients With Chronic Hepatitis B
Sponsor: Xiamen Amoytop Biotech Co., Ltd.
Summary
Studies have shown that chronic hepatitis B patients with low levels of HBsAg after nucleos(t)ide analog therapy have a higher chance of functional cure with sequential or combined pegylated interferon therapy, with about 30-50% of patients achieving HBsAg clearance and discontinuing therapy. There are some clinical practices on the long-term benefits of discontinuing antiviral therapy, but there is a lack of evidence-based clinical studies, especially on the relapse rate, duration of relapse, and factors influencing relapse after achieving functional cure. Furthermore, there is no guideline or expert consensus on the follow-up management strategy for patients who haven't achieved functional cure but whose HBsAg levels have been substantially reduced by treatment and are at low levels. Therefore, this study is planned to enroll participants who have completed the TB1901IFN to evaluate the long-term benefit of Peginterferon in combination with tenofovir disoproxil fumarate(TDF) and relapse in patients who have achieved functional cure, for participant with low-level HBsAg at the end of treatment, peginterferon combined with tenofovir alafenamide fumarate (TAF)therapy will be administered to explore the efficacy and safety of starting treatment after a period of drug discontinuation. Participants will be divided into 3 cohorts based on functional achievement and/or HBsAg levels after completion of TB1901IFN
Official title: A Multicenter, Prospective, Follow-up Study to Evaluate the Long-term Benefits of Peginterferon Alpha-2b Injection Combined With TDF in Patients With Chronic Hepatitis B
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
350
Start Date
2022-03-18
Completion Date
2029-07-31
Last Updated
2024-12-04
Healthy Volunteers
No
Conditions
Interventions
Peginterferon α-2b Injection; Tenofovir Alafenamide Fumarate
Peginterferon α-2b Injection, subcutaneous injection, once a week. Tenofovir Alafenamide Fumarate, Oral administration, once a day.
Locations (30)
Peking University First Hospital
Beijing, China
Beijing Youan Hospital, Capital Medical University
Beijing, China
The fifth medical center of PLA General Hospital
Beijing, China
The Second Xiangya Hospital of Central South University
Changsha, China
Xiangya Hospital Central South University
Changsha, China
Public Health Clinical Center of Chengdu
Chengdu, China
Sichuan Provincial People's Hospital
Chengdu, China
Mengchao Hepatobiliary Hosipital of Fujian Medical University
Fuzhou, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, China
Guangzhou Eighth People's Hospital
Guangzhou, China
The Third Affiliated Hospital,SUN YAT-SEN University
Guanzhou, China
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, China
The First Affiliated Hospital of Anhui Medical University
Hefei, China
Huashan Hospital ,Fudan University
Shanghai, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China
The Sixth People's Hospital of Shenyang
Shenyang, China
Peiking University Shenzhen Hospital
Shenzhen, China
The Third People's Hospital of shenzhen
Shenzhen, China
The First Hospital of Shanxi Medical University
Taiyuan, China
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, China
Tianjin Third Central Hospital
Tianjin, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, China
Traditional Chinese Medical hospital of Xinjiang Uygur Autonomous Region
Ürümqi, China
Tongji Hospital,Tongji Medical College Huazhong University of Science and Technology
Wuhan, China
Tangdu Hospital,Air Force Medical University
Xi'an, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
The First Affiliated Hospital of Xiamen University
Xiamen, China
Xiamen Hospital of Traditional Chinese Medicine
Xiamen, China
Yanbian University Hospital/Yanbian Hospital
Yanji, China
Henan Provincial People's Hospital
Zhengzhou, China