Trial Title:
A Prospective Study to Evaluate Peginterferon in Reducing the Incidence of HCC in CHB Patients
NCT ID:
NCT05671315
Condition:
Chronic Hepatitis B
Intermediate to High Risk of HCC
Conditions: Official terms:
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Hepatitis, Chronic
Peginterferon alfa-2b
Conditions: Keywords:
Chronic Hepatitis B
Hepatocellular Carcinoma
Peginterferon
Nucleos(t)ide analogue
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Peginterferon alfa-2b Injection, Nucleos (t) ide Analogue
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.
Arm group label:
Combined treatment group
Intervention type:
Drug
Intervention name:
Nucleos(t)ide analogue
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.
Arm group label:
Monotherapy group
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
60 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The Public Health Clinical Center Of Chengdu
Address:
City:
Chengdu
Country:
China
Status:
Recruiting
Contact:
Last name:
Yilan Zeng
Email:
2499081791@qq.com
Facility:
Name:
The First Affiliated Hospital of USTC Anhui Provincial Hospital
Address:
City:
Hefei
Country:
China
Status:
Recruiting
Contact:
Last name:
Yi Li
Email:
liyily2008@sina.com
Facility:
Name:
The Affiliated Hospital of Qingdao University
Address:
City:
Qingdao
Country:
China
Status:
Recruiting
Contact:
Last name:
Yuan Guo
Facility:
Name:
Ruijin Hospital Shanghai Jiao Tong University School of Medicine
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Qing Xie
Facility:
Name:
Shanghai Ninth People's Hospital Shanghai Jiao Tong University School of Medicine
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Jie Xu
Email:
dr.xu@aliyun.com
Facility:
Name:
Tongren Hospital Shanghai Jiao Tong University School of Medicine
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Qin Zhang
Email:
zhangq1030@163.com
Facility:
Name:
The Fifth People's Hospital Of Suzhou
Address:
City:
Suzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Chuanwu Zhu
Email:
zhuchw@126.com
Facility:
Name:
Xiamen Hospital of Traditional Chinese Medicin
Address:
City:
Xiamen
Country:
China
Status:
Recruiting
Contact:
Last name:
Lijuan Ouyang
Email:
oylj_1105@163.com
Facility:
Name:
The Tirth Affiliated Hospital Of Xinxiang Medical University
Address:
City:
Xinxiang
Country:
China
Status:
Recruiting
Contact:
Last name:
Weifeng Zhao
Email:
zwf7577@126.com
Start date:
July 3, 2019
Completion date:
April 2026
Lead sponsor:
Agency:
Qing XIe
Agency class:
Other
Source:
Ruijin Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05671315