NCT06746701 Study on the Treatment of Hepatitis B Virus(HBV) Infected Individuals With Peginterferon α-2b Combined With NA.
| NCT ID | NCT06746701 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Xiangya Hospital of Central South University |
| Condition | HBV |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2023-05-25 |
| Primary Completion | 2027-05-25 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2023-05-25 with a primary completion date of 2027-05-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
LeDu Zhou, Ph.D
PRINCIPAL INVESTIGATOR
Xiangya Hospital of Central South University
Frequently Asked Questions
Who can join the NCT06746701 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying HBV. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06746701 currently recruiting?
Yes, NCT06746701 is actively recruiting participants. Contact the research team at zhould@scu.cn for enrollment information.
Where is the NCT06746701 trial being conducted?
This trial is being conducted at Guangzhou, China, Chenzhou, China, Hengyang, China, Hengyang, China.
Who is sponsoring the NCT06746701 clinical trial?
NCT06746701 is sponsored by Xiangya Hospital of Central South University. The principal investigator is LeDu Zhou, Ph.D at Xiangya Hospital of Central South University. The trial plans to enroll 400 participants.