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| Name | Class |
|---|---|
| Peking University First Hospital | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | No Intervention | Participants who have achieved functional cure at the time of completion of TB1901IFN will be included and followed up for 5 years without any intervention. | |
| Cohort 2 | Experimental | Participants with S antigen decrease≥1log and the S antigen level <100IU/ml at enrollment, or who with S antigen decrease ≥1.5log and the S antigen level <1500IU/ml after TB1901IFN treatment, will initially treated with 72-week pulse treatment of peginterferon in combination with TAF, and then followed up to 5 years. |
|
| Cohort 3 | No Intervention | Except for those who already enrollment in Cohort 2, Participants with functional cure achievement will enroll in Cohort 3, and follow-up for 5 years without any study intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peginterferon α-2b Injection; Tenofovir Alafenamide Fumarate | Drug | Peginterferon α-2b Injection, subcutaneous injection, once a week. Tenofovir Alafenamide Fumarate, Oral administration, once a day. |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of Hepatocellular Carcinoma(HCC). | 5 years after the completion of the TB1901IFN study. | |
| The incidence all-cause mortality. | 5 years after the completion of the TB1901IFN study. | |
| Relapse within 5 years of discontinuation in participants who achieved functional cure. | Relapse was defined as the occurrence of two consecutive time, interval greater than one month, HBsAg≥0.05 IU/ml at any time during the follow-up period | 5 years after the completion of the TB1901IFN study. |
| Rate of functional cure of re-initiation of combination therapy after discontinued for more than 24 weeks in participants who had a favorable outcome on prior therapy and obtained low levels of S antigen. | After completing the 72-week combined re-treatment. |
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Inclusion Criteria:
For cohort 1 only; - Subjects who have achieved functional cure (defined as the disappearance of HBsAg at the completion of TB1901IFN, with or without the appearance of HBsAb);
For cohort 2 only:
For cohort 3 only:
- Participants who have not achieved functional cure upon completion of TB1901IFN (defined as HBsAg ≥ 0.05 IU/ml);
Exclusion Criteria:
- Suspected or confirmed HCC patients.
For Cohort 2 only:
For cohort 3 only:
- Participants who plan to enter Cohort 2.
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| Name | Affiliation | Role |
|---|---|---|
| Guiqiang Wang, Ph.D | Peking University First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Beijing | 100034 | China | |||
| Beijing Youan Hospital, Capital Medical University |
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| 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 |
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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