Trial Title:
Study on Screening, Verification and Intervention of High-risk Patients With Liver Cancer
NCT ID:
NCT05721300
Condition:
Hepatocellular Carcinoma
Chronic Hepatitis B
Conditions: Official terms:
Hepatitis B
Hepatitis B, Chronic
Carcinoma, Hepatocellular
Liver Neoplasms
Hepatitis
Hepatitis, Chronic
Interferons
Tenofovir
Entecavir
Conditions: Keywords:
Chronic hepatitis B (CHB)
hepatocellular carcinoma (HCC)
nucleos(t)ide analogues (NAs)
interferon
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:
NAs（"Entecavir"or"Tenofovir"or"Tenofovir alafenamide"） combined with interferon treatments
Description:
NAs（"Entecavir"or"Tenofovir"or"Tenofovir alafenamide"） combine with interferon treatments
for 48 weeks, and then continue with NAs treatment（"Entecavir"or"Tenofovir"or"Tenofovir
alafenamide"）
Arm group label:
experience group
Other name:
IFN group
Intervention type:
Drug
Intervention name:
NAs （"Entecavir"or"Tenofovir"or"Tenofovir alafenamide"） treatments
Description:
patients receive NAs（"Entecavir"or"Tenofovir"or"Tenofovir alafenamide"） treatment at
least 48 weeks
Arm group label:
control group
Summary:
The goal of this clinical trial is to test the outcomes of HBsAg(+) patients in the
treatments of NAs vs NAs plus IFN . The main questions it aims to answer are:
1. Clinical effect analysis of nucleoside analogs (NAs) group a group and NAs plus
interferon group after 48 weeks of treatment;
2. Repetitive effect and time effect of different drug treatment at different follow-up
time points;
3. To evaluate the difference of therapeutic effect of NAs or NAs combined with
interferon;
4. Follow up and compare the incidence of early liver cancer in each group.
Participants will be asked to receive NAs or NAs combined with interferon
treatments, and Regular blood sampling and color ultrasound examination.
Researchers will compare control group to see if occurrence of liver cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria (if one of them is met, it will be included):
1. HBsAg positive patients without liver cirrhosis:
1. Chronic hepatitis B virus（HBV） infected persons with positive serum HBV-DNA, if
their alanine aminotransferase(ALT) continues to be abnormal and other causes of ALT
increase are excluded;
2. In patients with positive serum HBV-DNA and normal ALT, liver histology showed
obvious liver inflammation (≥ G2) or fibrosis (≥S2);
3. ALT continues to be normal (once every 3 months, lasting for 12 months), but there
is a family history of cirrhosis/liver cancer and the age is>30 years old;
4. ALT is continuously normal (once every 3 months, lasting for 12 months), there is no
family history of liver cirrhosis/liver cancer but the age is more than 30 years
old, fibroscan or liver histology shows obvious liver inflammation or fibrosis;
5. Chronic HBV infected persons with negative serum HBV DNA who are receiving NA
treatment or who have previously received NA treatment.
2. HBsAg positive with iver cirrhosis patients Patients with compensatory cirrhosis,
regardless of ALT or HBeAg status. The diagnosis of hepatitis B cirrhosis is in
accordance with the diagnostic criteria of Chronic Hepatitis B (2019). It shall
conform to the following (1) and (2) (pathological diagnosis), or (1) and (3)
(clinical diagnosis).
1. At present, HBsAg is positive, or HBsAg is negative, HBcAb is positive, and there is
a clear history of chronic HBV infection (HBsAg positive in the past>6 months),
excluding other causes.
2. Pathology of liver biopsy was consistent with liver cirrhosis.
3. two or more of the following 5 items are met, and non cirrhotic portal hypertension
is excluded: ① Imaging examination shows signs of cirrhosis and (or) portal
hypertension; ② Endoscopy showed esophageal and gastric varices; ③ The determination
of liver hardness is consistent with liver cirrhosis; ④ Blood biochemical
examination showed that the albumin level decreased (<35g/L) and/or prothrombin
time（PT） prolonged (>3s longer than the control); ⑤ Blood routine examination showed
that platelet count was<100 * 10 ^ 9/L.
Exclusion Criteria:(if one of them is met, it will be excluded)
1. Previous history of decompensated liver function or clinical symptoms of
decompensated liver disease at baseline, such as hepatic encephalopathy, esophageal
variceal bleeding, ascites, splenomegaly, etc.
2. In the first 6 months of screening, they received NA (such as lamivudine, adefovir
dipivoxil tablets) or interferon treatment with high drug resistance rate;
3. Have received immunosuppressive agents or other immunomodulators (such as thymosin),
systemic cytotoxic drugs, and effective antiviral therapy including Chinese herbal
medicine (such as ganciclovir, lobcavir, and valaciclovir) within 6 months before
screening.
4. The laboratory examination showed liver failure during screening.
5. There are evidences supporting the diagnosis of hepatocellular carcinoma, such as
suspicious lesions found by ultrasound or imaging and/or serum alpha-fetoprotein
(AFP)>50ug/L.
6. It is accompanied by hepatitis C virus（HCV）, hepatitis D virus （HDV） and HIV
infection.
7. Presence of other liver diseases: combined with other pathogen infection,
drug-induced liver injury, alcoholic hepatitis, nonalcoholic steatohepatitis,
autoimmune liver disease, systemic diseases involving the liver, etc;
8. Subjects have other serious or active psychosomatic diseases, which may affect
patients' treatment, evaluation or compliance with the study protocol. It includes
any uncontrolled kidney, heart, lung, vascular, neurological, digestive, metabolic
diseases (diabetes, thyroid and adrenal diseases), immune deficiency diseases or
tumors with clinical significance.
9. There are contraindications to interferon treatment. Absolute contraindications
include pregnancy, psychiatric history, uncontrolled epilepsy, decompensated
cirrhosis, uncontrolled autoimmune disease, severe infection, retinal disease, heart
failure, chronic obstructive pulmonary disease and other basic diseases. Relative
contraindications include thyroid disease, past depression, uncontrolled diabetes,
hypertension, and heart disease.
10. Have a history of allergy to nucleoside analogues.
11. The researchers believed that the compliance of the subjects was poor.
12. The researcher believes that the subject is not suitable to participate in this
study.
Gender:
All
Minimum age:
35 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Boheng Zhang
Address:
City:
Xiamen
Zip:
361015
Country:
China
Status:
Recruiting
Contact:
Last name:
yanfang wu, master
Phone:
15980017053
Email:
wu.yanfang@zsxmhospital.com
Start date:
February 10, 2023
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Zhongshan Hospital (Xiamen), Fudan University
Agency class:
Other
Source:
Zhongshan Hospital (Xiamen), Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05721300
