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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

Recruitingn/aAges 18 Years - 70 YearsAllFirst Affiliated Hospital Xi'an Jiaotong Universi…
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In plain words

What the trial is, and whether it could suit you

Chronic hepatitis B can develop into cirrhosis and liver cancer, which seriously endangers the life and health of people. In China, HBV is mainly transmitted from mother to child, showing the phenomenon of family clusters. Similarly, cirrhosis and hepatocellular carcinoma occur in familial clusters. Familial clusters of HBV infection with unfavorable prognoses refers to HBV-infected patients from two consecutive generations of blood relatives, with at least one family member diagnosed with hepatitis B-related cirrhosis or hepatocellular carcinoma (HCC). Previous family investigations have shown that the risk and harm of HBV-related cirrhosis and hepatocellular carcinoma are significantly higher in families with familial clusters of HBV infection with unfavorable prognoses than in the general population. Currently, antiviral drugs used for CHB mainly include nucleoside analogues (NAs) an

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📋 Eligibility rules (as published)
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.
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What it tests

  • Peg IFN-α-2b
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Where

2 sites
First Affiliated Hospital of Xian Jiaotong University
Xi'an, China
First Affiliated Hospital of Xian Jiaotong University
Xi'an, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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