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A Prospective Study to Evaluate Peginterferon in Reducing the Incidence of HCC in CHB Patients

Primary Purpose

Chronic Hepatitis B, Intermediate to High Risk of HCC

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Peginterferon alfa-2b Injection, Nucleos (t) ide Analogue
Nucleos(t)ide analogue
Sponsored by
Qing XIe
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis B focused on measuring Chronic Hepatitis B, Hepatocellular Carcinoma, Peginterferon, Nucleos(t)ide analogue

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Aged 18 to 60 years and no gender limit (including 18 and 60 years). 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 co-infected with active hepatitis A, hepatitis C, hepatitis D, hepatitis E or HIV. 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.

Sites / Locations

  • The Public Health Clinical Center Of ChengduRecruiting
  • The First Affiliated Hospital of USTC Anhui Provincial HospitalRecruiting
  • The Affiliated Hospital of Qingdao UniversityRecruiting
  • Ruijin Hospital Shanghai Jiao Tong University School of MedicineRecruiting
  • Shanghai Ninth People's Hospital Shanghai Jiao Tong University School of MedicineRecruiting
  • Tongren Hospital Shanghai Jiao Tong University School of MedicineRecruiting
  • The Fifth People's Hospital Of SuzhouRecruiting
  • Xiamen Hospital of Traditional Chinese MedicinRecruiting
  • The Tirth Affiliated Hospital Of Xinxiang Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Combined treatment group

Monotherapy group

Arm Description

Peginterferon alfa-2b Injection combined Nucleos (t) ide Analogue therapy

Nucleos (t) ide Analogue monotherapy

Outcomes

Primary Outcome Measures

Change of HBsAg level compared to baseline

Secondary Outcome Measures

Proportion of patients with HBsAg clearance
Proportion of patients with HBsAg seroconversion
Proportion of patients with change of liver stiffness measurement (LSM)
Incidence of liver cirrhosis and hepatocellular carcinoma

Full Information

First Posted
March 15, 2020
Last Updated
May 23, 2023
Sponsor
Qing XIe
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1. Study Identification

Unique Protocol Identification Number
NCT05671315
Brief Title
A Prospective Study to Evaluate Peginterferon in Reducing the Incidence of HCC in CHB Patients
Official Title
A Prospective, Randomized, Open-label, Multicenter Study to Evaluate the Peginterferon, Comparing to Nucleos(t)Ide Analogues, in Reducing the Incidence of HCC in Chronic Hepatitis B Patients With Intermediate to High Liver Cancer Risks
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 3, 2019 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
April 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Qing XIe

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
China's new cases and deaths of hepatocellular carcinoma (HCC) rank first in the world. hepatocellular carcinoma is the third most morbid, second-most mortal malignancy in China. Up to 80% of hepatocellular carcinoma patients caused by HBV infection. Antiviral therapy can significantly reduce the incidence and mortality of hepatocellular carcinoma in patients with chronic hepatitis B (CHB), hinder the progression of liver disease, and effectively control the disease. However, studies in recent years have found that long-term therapy with Nucleos(t)ide analogue (NAs) cannot completely eliminate the risk of liver cancer in patients with chronic hepatitis B. In addition, a number of retrospective studies at home and abroad have shown that compared with long-term oral NAs, peginterferon can significantly reduce the risk of hepatocellular carcinoma in patients with chronic hepatitis B. However, there is limit prospective studies. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B, Intermediate to High Risk of HCC
Keywords
Chronic Hepatitis B, Hepatocellular Carcinoma, Peginterferon, Nucleos(t)ide analogue

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
267 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Combined treatment group
Arm Type
Experimental
Arm Description
Peginterferon alfa-2b Injection combined Nucleos (t) ide Analogue therapy
Arm Title
Monotherapy group
Arm Type
Active Comparator
Arm Description
Nucleos (t) ide Analogue monotherapy
Intervention Type
Drug
Intervention Name(s)
Peginterferon alfa-2b Injection, Nucleos (t) ide Analogue
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Nucleos(t)ide analogue
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of HBsAg level compared to baseline
Time Frame
week 48 of treatment
Secondary Outcome Measure Information:
Title
Proportion of patients with HBsAg clearance
Time Frame
At week 48 of treatment and 5 years of follow up
Title
Proportion of patients with HBsAg seroconversion
Time Frame
At week 48 of treatment and 5 years of follow up
Title
Proportion of patients with change of liver stiffness measurement (LSM)
Time Frame
At week 48 of treatment and 5 years of follow up
Title
Incidence of liver cirrhosis and hepatocellular carcinoma
Time Frame
At week 48 of treatment and 5 years of follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 18 to 60 years and no gender limit (including 18 and 60 years). 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 co-infected with active hepatitis A, hepatitis C, hepatitis D, hepatitis E or HIV. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qing Xie, Ph.D
Phone
86-13651804273
Email
profxieqing@163.com;xieqingrjh@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qing Xie
Organizational Affiliation
Ruijin Hospital, Shanghai
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Public Health Clinical Center Of Chengdu
City
Chengdu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yilan Zeng
Email
2499081791@qq.com
Facility Name
The First Affiliated Hospital of USTC Anhui Provincial Hospital
City
Hefei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Li
Email
liyily2008@sina.com
Facility Name
The Affiliated Hospital of Qingdao University
City
Qingdao
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuan Guo
Facility Name
Ruijin Hospital Shanghai Jiao Tong University School of Medicine
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qing Xie
Facility Name
Shanghai Ninth People's Hospital Shanghai Jiao Tong University School of Medicine
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Xu
Email
dr.xu@aliyun.com
Facility Name
Tongren Hospital Shanghai Jiao Tong University School of Medicine
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qin Zhang
Email
zhangq1030@163.com
Facility Name
The Fifth People's Hospital Of Suzhou
City
Suzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chuanwu Zhu
Email
zhuchw@126.com
Facility Name
Xiamen Hospital of Traditional Chinese Medicin
City
Xiamen
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lijuan Ouyang
Email
oylj_1105@163.com
Facility Name
The Tirth Affiliated Hospital Of Xinxiang Medical University
City
Xinxiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weifeng Zhao
Email
zwf7577@126.com

12. IPD Sharing Statement

Learn more about this trial

A Prospective Study to Evaluate Peginterferon in Reducing the Incidence of HCC in CHB Patients

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