Long-term outcomes of pegylated interferon alfa-2b in families with clustered hepatitis B and high risk of cirrhosis or liver cancer
Real-world Study Evaluating the Long-term Outcomes of Pegylated Interferon α-2b Treatment in the Families With Clusters of HBV Infection and Unfavorable Prognosis - A Prospective, Controlled, Multicenter, Cohort Study
This study will try pegylated interferon alfa-2b to see if it improves long-term outcomes for people with chronic hepatitis B from families where cirrhosis or liver cancer affects two generations.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | First Affiliated Hospital Xi'an Jiaotong University Academic / other |
| Locations | 2 sites (Xi'an, Shaanxi and 1 other locations) |
| Trial ID | NCT07079150 on ClinicalTrials.gov |
What this trial studies
This is a prospective, controlled, multicenter real-world cohort following people with chronic hepatitis B from families that show clustering of poor outcomes across generations. Participants treated with pegylated interferon alfa-2b will be followed and compared with appropriate control patients (for example, those on nucleos(t)ide analogues or usual care) to track virologic response, disease progression, and safety. The study will collect clinical events such as development of cirrhosis or hepatocellular carcinoma, laboratory measures, and adverse effects over the long term. Results aim to reflect outcomes in routine clinical practice rather than a randomized clinical trial setting.
Who should consider this trial
Good fit: Ideal candidates are people with chronic hepatitis B from families with infection across two consecutive generations and at least one relative diagnosed with hepatitis B-related cirrhosis or hepatocellular carcinoma, who have HBsAg positivity for more than six months and no contraindications to interferon.
Not a fit: Patients already diagnosed with hepatocellular carcinoma, other systemic tumors, or who have contraindications to interferon are unlikely to benefit from this treatment approach in the study context.
Why it matters
Potential benefit: If successful, the findings could help identify whether pegylated interferon alfa-2b lowers the long-term risk of cirrhosis or liver cancer in high-risk family clusters of chronic hepatitis B.
How similar studies have performed: Pegylated interferon alfa has shown antiviral and functional-cure benefits in some chronic hepatitis B studies, but applying it specifically to family clusters with unfavorable prognoses is relatively novel and not well established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Meet the criteria for a family cluster of unfavorable prognoses associated with HBV infection: that is, patients with HBV infection in two consecutive generations of blood relatives, and at least one patient with cirrhosis or HCC in two or more generations of blood relatives; * Chronic HBV-infected individuals from families with unfavorable prognoses clustering (meeting either (1)+(2) or (1)+(3) criteria): (1) Positive for HBsAg for more than 6 months; (2) Treated with nucleos(t)ide analogs (NAs); (3) Compensated cirrhosis due to hepatitis B (for details, see the "Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2022 Edition)"); * A negative pregnancy test within 24 hours before the first administration of medication in the treatment group (for women of childbearing age); * No contraindications for interferon treatment. Exclusion Criteria: * Patients diagnosed with liver cancer or other systemic tumors before treatment; * Patients with contraindications to Peg IFN α-2b use (for details, see the "Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2022 Edition)"); * Peripheral blood counts: WBC \< 3.0 × 10\^9/L, PLT \< 70 × 10\^9/L; * Liver function: ALT \> 5 × upper limit of normal (ULN), TBIL \> 2 × ULN; Individuals planning to receive organ transplantation or who have already undergone organ transplantation; * Those allergic to interferon or with any contraindication listed in the product information; * Any other conditions deemed unsuitable for enrollment by the investigator.
Where this trial is running
Xi'an, Shaanxi and 1 other locations
- First Affiliated Hospital of Xian Jiaotong University — Xi'an, Shaanxi, China (Not_yet_recruiting)
- First Affiliated Hospital of Xian Jiaotong University — Xi'an, Shaanxi, China (Recruiting)
Study contacts
- Study coordinator: Yingren Zhao, Professor
- Email: zhaoyingren@mail.xjtu.edu.cn
- Phone: 0086-029-85323437
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.