Long-term outcomes of pegylated interferon alfa-2b in families with clustered hepatitis B and high risk of cirrhosis or 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 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.

Why it matters

Who can join: the full rules

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 it's running

• First Affiliated Hospital of Xian Jiaotong University
  Xi'an, Shaanxi, China Recruiting
• First Affiliated Hospital of Xian Jiaotong University
  Xi'an, Shaanxi, China Not yet recruiting

Study contacts

• Study coordinator: Yingren Zhao, Professor
• Email: zhaoyingren@mail.xjtu.edu.cn
• Phone: 0086-029-85323437

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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.