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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: zhould@scu.cn
• Phone: 17373120367

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.