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ENROLLING BY INVITATION
NCT06707922
NA

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

Sponsor: Xiamen Amoytop Biotech Co., Ltd.

View on ClinicalTrials.gov

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

Interventions

DRUG

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