Clinical trial NCT06746701: Study on the Treatment of Hepatitis B Virus(HBV) Infected Individuals With Peginterferon α-2b Combined With NA.
Official title: Investigating the Clinical Cure Rate and the Risk Reduction of Hepatocellular Carcinoma in Chronic HBV Infected Individuals With a Family History of Liver Cancer Using PegIFN α-2b Combined With NA Treatment in a Real-world Study.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HBV
Keywords: Peginterferon α-2b injection
Nucleotide Analogues
HBV
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2024-12-24
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Select chronic HBV carriers with a family history of liver cancer from each center.

Brief summary: This is a retrospective prospective, open-label, multicenter clinical study aiming to recruit 400 individuals with a family history of liver cancer to explore the clinical cure rate and the effectiveness, feasibility, and safety of PEGylated interferon α-2b combined with nucleos(t)ide analogues in treating chronic HBV carriers with a family history of liver cancer for reducing the risk of liver cancer occurrence. Patients will enrolled into Group A (Peg-IFNα-2b combined with NA treatment group) or Group B (NA monotherapy group) based on their medication choices. Each group is expected to enroll 200 patients, with all patients followed up to 240 weeks. The dosage, frequency, and duration of treatment with Peg-IFN α-2b and NA will be prescribed by the researchers according to clinical practice and standard treatment protocols.


Eligibility criteria: Inclusion Criteria:

* Age18-65 years (inclusive of 18 and 65), no restriction on gender;
* HBsAg positive history for at least 6 months;
* Family history of liver cancer \[including first-degree and second-degree relatives; first-degree relatives are parents, children, and siblings (same parents), while second-degree relatives are uncles, aunts, grandparents, and great-grandparents; a family history of liver cancer means that one or more first-degree or second-degree relatives have had liver cancer\];
* Planning to or already receiving treatment with Peginterferon alpha-2b in combination with nucleoside (acid) analogs, or receiving nucleoside (acid) analogs treatment alone;
* Negative urine or serum pregnancy test within 24 hours before the first dose (for women of childbearing age);
* Willing to receive treatment and sign an informed consent form.

Exclusion Criteria:

* Allergy to interferon;
* History of using telbivudine for antiviral treatment;
* ALT(Alanine Aminotransferase) greater than 10 times the upper limit of normal, total bilirubin greater than 2 times the upper limit of normal;
* Decompensated liver cirrhosis;
* Neutrophil count \< 1.5 x 10\^9/L or platelet count \< 80 x 10\^9/L;
* Presence of severe lesions in vital organs such as the cardiovascular, pulmonary, renal, brain, and fundus;
* Those with autoimmune diseases, psychiatric disorders, poorly controlled diabetes, or thyroid dysfunction (hyperthyroidism or hypothyroidism);
* Confirmed or suspected liver cancer or other malignant tumors;
* Post-organ transplant or preparing for organ transplantation;
* Currently using immunosuppressants;
* Pregnant or planning to become pregnant within 2 years;
* Alcohol or drug addicts;
* HIV co-infection;
* Other conditions deemed unsuitable for interferon use by the attending physician.

Primary outcomes:
measure: Clinical cure rate
timeFrame: through study completion, an average of 24 weeks.
measure: Liver cancer incidence rate
timeFrame: through study completion, an average of 24 weeks.
Secondary outcomes:
measure: The decrease in HBsAg compared to baseline.
timeFrame: through study completion, an average of 24 weeks.
measure: HBsAg seroconversion rate
timeFrame: through study completion, an average of 24 weeks.
measure: Changes of biomarkers after disease progression-related markers such as HBV DNA quantification compared to baseline.
timeFrame: through study completion, an average of 24 weeks.
measure: Incidence of abnormal and clinically relevant changes in vital signs
timeFrame: through study completion, an average of 24 weeks.
measure: Incidence of treatment-emergent adverse event (AE)
timeFrame: through study completion, an average of 24 weeks.
measure: Incidence of abnormal and clinically relevant changes in laboratory assessments
timeFrame: through study completion, an average of 24 weeks.
measure: Incidence of severe acute allergic reactions occurring during treatment.
timeFrame: through study completion, an average of 24 weeks.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Chenzhou
country: China
facility: Chenzhou Second People's Hospital
state: Hunan
city: Hengyang
country: China
facility: First Affiliated Hospital of Nanhua University
state: Hunan
city: Hengyang
country: China
facility: Hengyang Third People's Hospital
state: Hunan
Study officials:
affiliation: Xiangya Hospital of Central South University
name: LeDu Zhou, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: