Efficacy and Safety Study of Peginterferon Alfacon-2 to Treat Chronic Hepatitis B Virus Infection
NCT Number: NCT06544551
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Chronic Hepatitis B Virus Infection
Interventions: DRUG: Peginterferon Alfacon-2|DRUG: Peginterferon Alfacon-2 placebo
Sponsor: Beijing Kawin Technology Share-Holding Co., Ltd.
Sex: ALL
Age: ADULT
Enrollment: 336
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2021-12-28
Completion Date: 2023-12-30
Locations: Beijing Ditan Hospital, Capital Medical University, Beijing, China|Beijing Youan Hospital, Capital Medical University, Beijing, China|Peking university Peoole's hospital, Beijing, China|The First Hospital of Jilin University, Changchun, China|The second xiangya hospital of central south university, Changsha, China|Xiangya Hospital Central South University, Changsha, China|Sichuan Provincial People's Hospital, Chengdu, China|The Peoole's hospital of Chizhou, Chizhou, China|The First Affiliated Hospital of Army Medical University, Chongqing, China|The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China|Mengchao hepatobiliary hospital of Fujian medical university, Fuzhou, China|The First Affiliated Hospital of Fujian Medical University, Fuzhou, China|Guangzhou Eighth People's Hospital, Guangzhou, China|The Fourth Affiliated Hospital of Harbin Medical University, Harbin, China|Heze Municipal Hospital, Heze, China|Shandong Public Health Clinical Center, Jinan, China|Hebei petro china central hospital, Langfang, China|The First Affiliated Hospital of Nanchang University, Nanchang, China|The Second Hospital of Nanjing, Nanjing, China|Pingxiang NO.2 People's Hospital, Pingxiang, China|Qingdao Municipal Hospital, Qingdao, China|The Peoole's hospital of Qingyuan, Qingyuan, China|The Sixth People's Hospital of Shenyang, Shenyang, China|Shijiazhuang Hospital of Traditional Chinese Medicine, Shijiazhuang, China|The Third Hospital of Hebei Medical University, Shijiazhuang, China|The Second People's Hospital of Tianjin, Tianjin, China|Tianjin Third Central Hospital, Tianjin, China|Tongji medical college of Hust, Wuhan, China|Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China|The Second Affiliated Hospital of Xian Jiaotong University, Xi'an, China|The third affiliated hospital of Xingxiang medical university, Xingxiang, China|Yanbian University Hospital, Yanbian, China|Henan People's Hospital, Zhengzhou, China|The Sixth People's Hospital of Zhengzhou, Zhengzhou, China

Summary:
Current clinical practices has shown promising prospects of the therapy strategy of interferon combined with nucleos(t)ides in patients with chronic hepatitis B, but the safety and efficacy has not been fully studied. This study is aimed to exploit the safety and efficacy of the study drug, Peginterferon Alfacon-2 injection, with nucleos(t)ide (NAs), Tenofovir alafenamide Fumarate Tablets (TAF), in the patients with hepatitis B virus infection.

Primary Outcome Measures: Proportion of patients with HBsAg negative., Percentage of Participants with HBsAg \<0.05 IU/mL, 72 weeks