Study on the Treatment of Hepatitis B Virus(HBV) Infected Individuals With Peginterferon α-2b Combined With NA.

Launched by XIANGYA HOSPITAL OF CENTRAL SOUTH UNIVERSITY · Dec 17, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for individuals infected with the Hepatitis B virus (HBV), particularly those who have a family history of liver cancer. The researchers want to see how effective and safe a combination of two treatments—Peginterferon α-2b and nucleos(t)ide analogues (often referred to as NA)—is in helping these patients. They are looking to enroll 400 participants, who will be divided into two groups: one group will receive both treatments, while the other will receive only NA. The goal is to determine if this combined treatment can help reduce the risk of developing liver cancer over a follow-up period of up to 240 weeks.

To be eligible for the trial, participants must be between 18 and 65 years old, have been diagnosed with HBV for at least six months, and have a family history of liver cancer. They should also be planning to start treatment with Peginterferon α-2b or already receiving treatment with NA alone. Participants can expect to follow a treatment plan set by the researchers, and they will need to provide consent to join the study. It's important to note that certain health conditions or previous treatments may exclude individuals from participating, so it's best to discuss eligibility with a healthcare provider.

Gender

ALL

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.