A Follow-up Study of Peginterferon Alfa-2b Combined With TDF in Patients With Chronic Hepatitis B
NCT ID: NCT06707922
Last Updated: 2024-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
350 participants
INTERVENTIONAL
2022-03-18
2029-07-31
Brief Summary
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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
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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Cohort 1
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.
No interventions assigned to this group
Cohort 2
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.
Peginterferon α-2b Injection; Tenofovir Alafenamide Fumarate
Peginterferon α-2b Injection, subcutaneous injection, once a week. Tenofovir Alafenamide Fumarate, Oral administration, once a day.
Cohort 3
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.
No interventions assigned to this group
Interventions
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Peginterferon α-2b Injection; Tenofovir Alafenamide Fumarate
Peginterferon α-2b Injection, subcutaneous injection, once a week. Tenofovir Alafenamide Fumarate, Oral administration, once a day.
Eligibility Criteria
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Inclusion Criteria
* Voluntary enrollment, understand and sign the informed consent form.
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:
* At the completion of TB1901IFN, the S antigen level has decreased by ≥1 log compared to the baseline, with an S antigen level of less than 100 IU/ml, or the S antigen level has decreased by ≥1.5 log compared to the baseline, with an S antigen level of less than 1500 IU/ml;
* Willing to accept the treatment of peginterferon combined with TAF;
For cohort 3 only:
\- Participants who have not achieved functional cure upon completion of TB1901IFN (defined as HBsAg ≥ 0.05 IU/ml)；
Exclusion Criteria
For Cohort 2 only:
* Suspected or confirmed liver cirrhosis.
* Pregnant, breastfeeding women, or those who plan to conceive during the combined medication treatment period.
* Evidence of acute severe liver injury: e.g. ALT \> 10 times of the upper limit of normal (ULN), or a significant increase in ALT accompanied by a significant increase in bilirubin;
* Evidence of decompensated liver disease: serum total bilirubin \> 2ULN, serum albumin \< 35 g/L, prothrombin time extended by more than 3 seconds beyond ULN, prothrombin activity \< 60%; or a history of decompensated liver cirrhosis;
* Kidney disease: acute or chronic nephritis, renal insufficiency, nephrotic syndrome, etc., or serum creatinine \> 1ULN;
* Neutrophil count \< 1.5×10\^9/L, platelet count \< 90×10\^9/L;
* Severe retinopathy or other severe ophthalmic diseases;
* Other conditions deemed by the investigator to be unsuitable for participation in the cohort 2.
For cohort 3 only:
\- Participants who plan to enter Cohort 2.
18 Years
ALL
No
Sponsors
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Peking University First Hospital
OTHER
Xiamen Amoytop Biotech Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Guiqiang Wang, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Peking University First Hospital
Locations
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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
Countries
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Other Identifiers
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TB2111IFN
Identifier Type: -
Identifier Source: org_study_id