Treatment for Hepatitis B in individuals with a family history of liver cancer

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.

This study is testing if a combination treatment of Peginterferon α-2b and other medications can help people with a family history of liver cancer who have chronic Hepatitis B feel better and lower their risk of developing liver cancer.

Quick facts

• Study type: Observational
• Enrollment: 400 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Xiangya Hospital of Central South University (Academic / other)
• Locations: 4 sites (Guangzhou, Guangdong and 3 other locations)
• Trial ID: NCT06746701 on ClinicalTrials.gov

What this trial studies

This observational study aims to recruit 400 individuals with a family history of liver cancer to evaluate the effectiveness and safety of Peginterferon α-2b combined with nucleos(t)ide analogues in treating chronic HBV carriers. Participants will be divided into two groups: one receiving the combination treatment and the other receiving nucleos(t)ide analogues alone. The study will follow patients for up to 240 weeks to assess the clinical cure rate and the potential reduction in liver cancer risk. The treatment regimen will be tailored according to standard clinical practices.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 18-65 with a positive HBsAg history for at least 6 months and a family history of liver cancer.

Not a fit: Patients with allergies to interferon or a history of using telbivudine for antiviral treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly reduce the risk of liver cancer in patients with chronic HBV and a family history of the disease.

How similar studies have performed: Other studies have shown promise in using Peginterferon α-2b for HBV treatment, but this specific combination approach is less commonly tested.

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.

Where this trial is running

Guangzhou, Guangdong and 3 other locations

• The Third Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
• Chenzhou Second People's Hospital — Chenzhou, Hunan, China (Recruiting)
• First Affiliated Hospital of Nanhua University — Hengyang, Hunan, China (Recruiting)
• Hengyang Third People's Hospital — Hengyang, Hunan, China (Recruiting)

Study contacts

• Principal investigator: LeDu Zhou, Ph.D — Xiangya Hospital of Central South University
• Study coordinator: LeDu Zhou, Ph.D

Conditions HBV; Peginterferon α-2b injection; Nucleotide Analogues