Efficacy and Safety Study of Peginterferon Alfacon-2 to Treat Chronic Hepatitis B Virus Infection

PHASE3CompletedINTERVENTIONAL
Enrollment

336

Participants

Timeline

Start Date

December 28, 2021

Primary Completion Date

November 30, 2023

Study Completion Date

December 30, 2023

Conditions
Chronic Hepatitis B Virus Infection
Interventions
DRUG

Peginterferon Alfacon-2

Peginterferon Alfacon-2 injection will be weekly subcutaneous injected for 48 weeks. Tenofovir alafenamide Fumarate Tablets(TAF) will be take orally for at least 48 weeks, not more than 72 weeks. Peg-interferon Alfacon-2 and TAF will discontinue when HBsAg levels is less than 0.05 IU/mL and HBV DNA is below 10 IU/mL during 48-72 weeks.

DRUG

Peginterferon Alfacon-2 placebo

Peginterferon Alfacon-2 placebo injection will be weekly subcutaneous injected for 48 weeks. Tenofovir alafenamide Fumarate Tablets(TAF) will be take orally for at least 48 weeks, not more than 72 weeks. Peg-interferon Alfacon-2 and TAF will discontinue when HBsAg levels is less than 0.05 IU/mL and HBV DNA is below 10 IU/mL during 48-72 weeks.

Trial Locations (34)

Unknown

Beijing Ditan Hospital, Capital Medical University, Beijing

Beijing Youan Hospital, Capital Medical University, Beijing

Peking university Peoole's hospital, Beijing

The First Hospital of Jilin University, Changchun

The second xiangya hospital of central south university, Changsha

Xiangya Hospital Central South University, Changsha

Sichuan Provincial People's Hospital, Chengdu

The Peoole's hospital of Chizhou, Chizhou

The First Affiliated Hospital of Army Medical University, Chongqing

The Second Affiliated Hospital of Chongqing Medical University, Chongqing

Mengchao hepatobiliary hospital of Fujian medical university, Fuzhou

The First Affiliated Hospital of Fujian Medical University, Fuzhou

Guangzhou Eighth People's Hospital, Guangzhou

The Fourth Affiliated Hospital of Harbin Medical University, Harbin

Heze Municipal Hospital, Heze

Shandong Public Health Clinical Center, Jinan

Hebei petro china central hospital, Langfang

The First Affiliated Hospital of Nanchang University, Nanchang

The Second Hospital of Nanjing, Nanjing

Pingxiang NO.2 People's Hospital, Pingxiang

Qingdao Municipal Hospital, Qingdao

The Peoole's hospital of Qingyuan, Qingyuan

The Sixth People's Hospital of Shenyang, Shenyang

Shijiazhuang Hospital of Traditional Chinese Medicine, Shijiazhuang

The Third Hospital of Hebei Medical University, Shijiazhuang

The Second People's Hospital of Tianjin, Tianjin

Tianjin Third Central Hospital, Tianjin

Tongji medical college of Hust, Wuhan

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan

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

The third affiliated hospital of Xingxiang medical university, Xingxiang

Yanbian University Hospital, Yanbian

Henan People's Hospital, Zhengzhou

The Sixth People's Hospital of Zhengzhou, Zhengzhou

All Listed Sponsors
lead

Beijing Kawin Technology Share-Holding Co., Ltd.

INDUSTRY

NCT06544551 - Efficacy and Safety Study of Peginterferon Alfacon-2 to Treat Chronic Hepatitis B Virus Infection | Biotech Hunter | Biotech Hunter