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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
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
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Start Date
March 18, 2022
Primary Completion Date
May 31, 2029
Completion Date
July 31, 2029
Last Updated
December 4, 2024
350
ESTIMATED participants
Peginterferon α-2b Injection; Tenofovir Alafenamide Fumarate
DRUG
Lead Sponsor
Xiamen Amoytop Biotech Co., Ltd.
Collaborators
NCT06671093
NCT06885710
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06263959