A Study of Peginterferon Alfa-2b Combined With TDF in Patients With Chronic Hepatitis B

PHASE3CompletedINTERVENTIONAL
Enrollment

475

Participants

Timeline

Start Date

December 4, 2019

Primary Completion Date

November 30, 2023

Study Completion Date

December 7, 2023

Conditions
Chronic Hepatitis B
Interventions
DRUG

Peginterferon alfa-2b injection

Peginterferon alfa-2b injection (high dose) will be weekly subcutaneous injected for 8 weeks and then stop for 4 weeks, 12 week a cycle, up to 12 cycles (144 weeks) at most. TDF will be taken orally during the whole treatment period. And then followed for 24 weeks after treatment.

DRUG

Peginterferon alfa-2b injection

Peginterferon alfa-2b injection (low dose) will be weekly subcutaneous injected for 8 weeks and then stop for 4 weeks, 12 week a cycle, up to 12 cycles (144 weeks) at most. TDF will be taken orally during the whole treatment period. And then followed for 24 weeks after treatment.

DRUG

TDF

Patients will take TDF orally for the first 48 weeks, and then one can choose to continue the single-TDF treatment up to 144 weeks, or may choose to change to receive peginterferon alfa-2b combined TDF therapy for the later 96 weeks, peginterferon alfa-2b will be weekly subcutaneous injected for 8 weeks and then stop for 4 weeks, 12 weeks a cycle. And then followed for 24 weeks after treatment.

DRUG

Peginterferon alfa-2b injection

Peginterferon alfa-2b injection will be weekly subcutaneous injected for 8 weeks and then stop for 4 weeks, 12 week a cycle, up to 12 cycles (144 weeks) at most. TDF will be taken orally during the whole treatment period. And then followed for 24 weeks after treatment.

Trial Locations (33)

Unknown

Beijing Ditan Hospital, Capital Medical University, Beijing

Beijing Youan Hospital, Capital Medical University, Beijing

Peking University First Hospital, Beijing

The fifth medical center of PLA General Hospital, Beijing

The Second Xiangya Hospital of Central South University, Changsha

Xiangya Hospital Central South University, Changsha

Public Health Clinical Center of Chengdu, Chengdu

Sichuan Provincial People's Hospital, Chengdu

Mengchao Hepatobiliary Hosipital of Fujian Medical University, Fuzhou

The First Affiliated Hospital of Fujian Medical University, Fuzhou

The Ninth Hospital of the Joint Logistic Support Force of the Chinese People's Liberation Army, Fuzhou

Guangzhou Eighth People's Hospital, Guangzhou

The Third Affiliated Hospital,SUN YAT-SEN University, Guangzhou

The Fourth Affiliated Hospital of Harbin Medical University, Harbin

The First Affiliated Hospital of Anhui Medical University, Hefei

Nanjing Drum Tower Hospital/The First Affiliated Hospital of Nanjing University Medical School, Nanjing

Huashan Hospital affiliated to Fudan University, Shanghai

Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai

The Sixth People's Hospital of Shenyang, Shenyang

Peiking University Shenzhen Hospital, Shenzhen

The Third People's Hospital of shenzhen, Shenzhen

The First Hospital of Shanxi Medical University, Taiyuan

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin

Tianjin Third Central Hospital, Tianjin

The First Affiliated Hospital of Xinjiang Medical University, Ürümqi

Traditional Chinese Medicine hospital of Xinjiang Uygur Autonomous Region, Ürümqi

Tongji Hospital/Tongji Medical College Huazhong University of Science & Technology, Wuhan

Tangdu Hospital, Xi'an

The First Affiliated Hospital of Xian Jiaotong University, Xi'an

The First Affiliated Hospital of Xiamen University, Xiamen

Xiamen Hospital of Traditional Chinese Medicine, Xiamen

Yanbian University Hospital/Yanbian Hospital, Yanbian

Henan Provincial People's Hospital, Zhengzhou

All Listed Sponsors
collaborator

Peking University First Hospital

OTHER

lead

Xiamen Amoytop Biotech Co., Ltd.

INDUSTRY

NCT04846491 - A Study of Peginterferon Alfa-2b Combined With TDF in Patients With Chronic Hepatitis B | Biotech Hunter | Biotech Hunter