Peginterferon plus antivirals for chronic hepatitis B with family liver cancer history
Compares peginterferon plus antivirals versus antivirals alone in chronic hepatitis B carriers.
Plain-language title generated from the registry record
Registry title: Study on the Treatment of Hepatitis B Virus(HBV) Infected Individuals With Peginterferon α-2b Combined With NA.
Key facts
- Where
- Chenzhou, Guangzhou, and Hengyang, ChinaSee the 4 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT06746701, who can take part
Where in China
- Chenzhou Second People's HospitalChenzhou, ChinaTaking people
- The Third Affiliated Hospital of Sun Yat-Sen UniversityGuangzhou, ChinaTaking people
- First Affiliated Hospital of Nanhua UniversityHengyang, ChinaTaking people
- Hengyang Third People's HospitalHengyang, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Xiangya Hospital of Central South University
- Trial code
- NCT06746701
- Record updated
- 24 December 2024
- Original description
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.Read full original descriptionShow less
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 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.
Inclusion: 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: Post-organ transplant or preparing for organ transplantation; Currently using immunosuppressants; Alcohol or drug addicts; Allergy to interferon; History of using telbivudine for antiviral treatment; Those with autoimmune diseases, psychiatric disorders, poorly controlled diabetes, or thyroid dysfunction (hyperthyroidism or hypothyroidism); Confirmed or suspected liver cancer or other malignant tumors; HIV co-infection; Other conditions deemed unsuitable for interferon use by the attending physician; ALT(Alanine Aminotransferase) greater than 10 times the upper limit of normal, total bilirubin greater than 2 times the upper limit of normal; Neutrophil count < 1.5 x 10\^9/L or platelet count < 80 x 10\^9/L; Decompensated liver cirrhosis; Presence of severe lesions in vital organs such as the cardiovascular, pulmonary, renal, brain, and fundus; Pregnant or planning to become pregnant within 2 years.