A Prospective Study to Evaluate Peginterferon in Reducing the Incidence of HCC in CHB Patients
NCT ID: NCT05671315
Last Updated: 2023-05-25
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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RECRUITING
NA
267 participants
INTERVENTIONAL
2019-07-03
2026-04-30
Brief Summary
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This multicenter, randomized, open-label, controlled trial study is aim to evaluate the pegylated interferon alfa-2b injection in comparing to NAs in reducing the incidence of hepatocellular carcinoma, to provide evidences for new management and treatment strategy options for improving clinical outcomes for the chronic hepatitis B patients. About 267 chronic hepatitis patients with intermediate to high risk of liver cancer who are now receiving nucleoside therapy will be enrolled. Subjects will be randomized into the peginterferon combined NAs group and the NAs monotherapy group at a ratio of 2:1. Level of HBsAg, proportion of patients with HBsAg clearance and seroconversion, incidence of liver cirrhosis and hepatocellular carcinoma will be assessed.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Combined treatment group
Peginterferon alfa-2b Injection combined Nucleos (t) ide Analogue therapy
Peginterferon alfa-2b Injection, Nucleos (t) ide Analogue
1.Peginterferon alfa-2b injection: 180μg, subcutaneously inject, once a week, from week 1 to Week 48.
2, NAs: Dose please follow the approved dosage, once daily, from the first day until when discontinuation is indicated.
NAs Discontinuation Criteria: A total course of treatment is recommended for at least 4 years, and discontinuation may be considered if HBV DNA is below the lower limit of detection, Alanine aminotransferase renormalization, and HBeAg serological conversion, and remain unchanged (test every 6 months) during a consolidation therapy for at least 3 years. However, a prolonged course of treatment may reduce relapse.
Monotherapy group
Nucleos (t) ide Analogue monotherapy
Nucleos(t)ide analogue
NAs: Dose please follow the approved dosage, once daily, from the first day until when discontinuation is indicated.
NAs Discontinuation Criteria: A total course of treatment is recommended for at least 4 years, and discontinuation may be considered if HBV DNA is below the lower limit of detection, Alanine aminotransferase renormalization, and HBeAg serological conversion, and remain unchanged (test every 6 months) during a consolidation therapy for at least 3 years. However, a prolonged course of treatment may reduce relapse.
Interventions
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Peginterferon alfa-2b Injection, Nucleos (t) ide Analogue
1.Peginterferon alfa-2b injection: 180μg, subcutaneously inject, once a week, from week 1 to Week 48.
2, NAs: Dose please follow the approved dosage, once daily, from the first day until when discontinuation is indicated.
NAs Discontinuation Criteria: A total course of treatment is recommended for at least 4 years, and discontinuation may be considered if HBV DNA is below the lower limit of detection, Alanine aminotransferase renormalization, and HBeAg serological conversion, and remain unchanged (test every 6 months) during a consolidation therapy for at least 3 years. However, a prolonged course of treatment may reduce relapse.
Nucleos(t)ide analogue
NAs: Dose please follow the approved dosage, once daily, from the first day until when discontinuation is indicated.
NAs Discontinuation Criteria: A total course of treatment is recommended for at least 4 years, and discontinuation may be considered if HBV DNA is below the lower limit of detection, Alanine aminotransferase renormalization, and HBeAg serological conversion, and remain unchanged (test every 6 months) during a consolidation therapy for at least 3 years. However, a prolonged course of treatment may reduce relapse.
Eligibility Criteria
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Inclusion Criteria
* HBsAg positive for more than 6 months.
* Patients with intermediate to high liver cancer risks. Refers to if at least one of the following items is met.
* Male patient aged above 40 years.
* Patients with a history of cirrhosis and/or family history of liver cancer.
* Patients with metabolic diseases, such as diabetes, fatty liver, etc.
* Any liver cancer assessment model of chronic hepatitis B patients suggested that liver cancer was at intermediate to high risk.
* Have received Nucleos(t)ide analogue treatment for more than 24 weeks, and currently receiving Nucleos(t)ide analogue, while HBV DNA is undetectable (HBV DNA below 300 IU/mL or 1000 copies/mL).
* Urine and/or serum pregnancy test within 24 hours prior to the first dose must be negative for female patients of childbearing potential.
* Understand and voluntarily sign informed consent form.
Exclusion Criteria
* Patients who have previously received interferon therapy.
* Alpha-fetoprotein greater than 100 ng/mL at screening, or liver imaging suggestive of liver tumor.
* Decompensated liver disease (Child-Pugh score ≥ 5).
* Pregnant or lactating women or patients planning to become pregnant or cannot to take contraception during the study.
* Neutrophil count \< 1.5 x 109/L, platelet count \< 90 x 109 cells/L, or Creatinine 1.5 times higher than the upper limit of normal.
* Patients with severe psychiatric history, particularly depression.
* History of immune-mediated disease or levels of autoimmune antibodies markedly elevated.
* Patients with severe diseases in major organ, such as heart, lung, kidney, brain, blood, etc., and patients with malignancies.
* Patients with poorly controlled diabetes, hypertension, and thyroid disease.
* Patients with history of severe retinopathy or other evidence of retinopathy.
* Patient who ever received organ transplantation, or planning to receive organ transplantation.
* Patients who are allergic to interferon or any of its ingredients.
* Other circumstances that the investigator deems inappropriate to participate in this study.
18 Years
60 Years
ALL
No
Sponsors
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Qing XIe
OTHER
Responsible Party
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Qing XIe
Director of Department of Infectious Disease, Rui Jin Hospital
Principal Investigators
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Qing Xie
Role: PRINCIPAL_INVESTIGATOR
Ruijin Hospital, Shanghai
Locations
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The Public Health Clinical Center Of Chengdu
Chengdu, , China
The First Affiliated Hospital of USTC Anhui Provincial Hospital
Hefei, , China
The Affiliated Hospital of Qingdao University
Qingdao, , China
Ruijin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, , China
Shanghai Ninth People's Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, , China
Tongren Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, , China
The Fifth People's Hospital Of Suzhou
Suzhou, , China
Xiamen Hospital of Traditional Chinese Medicin
Xiamen, , China
The Tirth Affiliated Hospital Of Xinxiang Medical University
Xinxiang, , China
Countries
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Central Contacts
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Facility Contacts
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Yuan Guo
Role: primary
Qing Xie
Role: primary
References
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Jiang S, Guo S, Huang Y, Xu J, Li Y, Zeng Y, Guo Y, Ouyang L, Zhu C, Zhao W, Zhang Q, Guo Q, Xin H, Xie Q. Interim analysis of the PARADISE study: Benefits of add-on peginterferon-alpha in NA-treated patients with CHB. Antiviral Res. 2024 Jun;226:105892. doi: 10.1016/j.antiviral.2024.105892. Epub 2024 Apr 23.
Other Identifiers
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Paradise
Identifier Type: -
Identifier Source: org_study_id
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