Actively Recruiting
Real-world Study Evaluating the Long-term Outcomes of Pegylated Interferon alpha-2b Treatment in Families With HBV Infection Clusters and Unfavorable Prognosis A Prospective, Controlled, Multicenter Cohort Study
Led by First Affiliated Hospital Xi'an Jiaotong University · Updated on 2025-07-22
1500
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the long-term outcomes of antiviral treatments for chronic hepatitis B (CHB) in families where the infection has unfavorable prognoses, such as cirrhosis and liver cancer. This study focuses on patients from two consecutive generations of blood relatives affected by hepatitis B virus (HBV) infection, who face a higher risk of developing serious liver complications. The goal is to compare the effects of pegylated interferon alpha-2b (Peg IFN \u03b1-2b) combined with first-line nucleoside analogues (NAs) versus NAs alone, to provide evidence-based guidance for managing this difficult-to-treat population. The study observes two patient groups: one receiving combination therapy with Peg IFN \u03b1-2b and NAs, and the other receiving NAs monotherapy. Peg IFN treatment lasts at least 48 weeks with doses tailored by clinicians, while NAs include drugs such as entecavir, tenofovir disoproxil fumarate, tenofovir alafenamide fumarate, or tenofovir amibufenamide. Patients may switch or add NAs if virological breakthrough occurs. This is a non-interventional, prospective, multicenter cohort study where treatments are chosen by doctors and patients. Data on antiviral therapies, laboratory tests, medical examinations, adverse events, and concomitant medications are collected over a 7-year follow-up period. Participants will undergo regular evaluations including lab tests and medical assessments at defined time points during the study. Researchers will monitor the incidence of cirrhosis, hepatocellular carcinoma (HCC), seroconversion rates, viral load levels, and overall survival. Patient adherence is supported through education, reminders, and follow-up tracking. Safety monitoring includes recording adverse events and changes in clinical parameters, with data quality ensured through standardized procedures and audits. The study plans to enroll both non-cirrhotic and compensated cirrhosis patients to analyze long-term outcomes and provide global clinical data for improved treatment decisions.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with HBV infection in two consecutive generations of blood relatives, with at least one family member diagnosed with cirrhosis or hepatocellular carcinoma (HCC)
- Positive for hepatitis B surface antigen (HBsAg) for more than 6 months
- Treated with nucleoside or nucleotide analogues (NAs) or have compensated cirrhosis due to hepatitis B
- Negative pregnancy test within 24 hours before first medication dose for women of childbearing age
- No contraindications to interferon treatment
You will not qualify if you...
- Diagnosis of liver cancer or other systemic tumors before treatment
- Contraindications to Peg IFN alpha-2b as per treatment guidelines
- Low peripheral blood counts: white blood cells less than 3.0 x 10^9/L, platelets less than 70 x 10^9/L
- Liver function abnormalities: ALT greater than 5 times upper limit of normal, total bilirubin greater than 2 times upper limit
- Individuals planning or having undergone organ transplantation
- Allergic to interferon or with contraindications listed in product information
- Any other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At least 48 weeks
Participants receive antiviral treatment with either Peg IFN-α-2b combined with nucleos(t)ide analogues (NAs) or NAs monotherapy for chronic hepatitis B.
Regular follow-up visits approximately every 24 weeks during treatment
Duration - Up to 7 years from enrollment
Participants are observed for long-term outcomes including the incidence of cirrhosis, hepatocellular carcinoma (HCC), and overall survival following antiviral treatment.
Follow-up visits every 24 weeks up to 7 years
Trial Site Locations
Total: 2 locations
1
First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, China, 710061
Not Yet Recruiting
2
First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, China, 710061
Actively Recruiting
Research Team
Y
Yingren Zhao, Professor
Z
Ze Zhang
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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