Actively Recruiting
Study on the Antiviral Therapy and Prognosis of Patients With Chronic HBV Infection
Led by Xiangya Hospital of Central South University · Updated on 2022-05-26
500
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Hepatitis B virus (HBV) infection affects millions worldwide, with China having the largest number of cases. This research focuses on chronic HBV infection and aims to explore how different antiviral treatments impact patients' health and long-term outcomes. The study seeks to understand which clinical features relate to treatment success and disease prognosis to support global efforts to reduce HBV as a public health threat by 2030. Participants with chronic HBV infection will be grouped based on their treatment: pegylated interferon (peg-IFN-alpha) alone, nucleos(t)ide analogues (NAs) alone, or a combination of both. Researchers will monitor patients by measuring serum HBV DNA levels, serological tests, liver function, and alpha-fetoprotein (AFP) every three to six months. Samples of serum, feces, urine, and liver tissue (if necessary) will be collected during follow-up to assess the therapy's effects. Throughout the study, patients will undergo regular blood tests and clinical evaluations to track viral response, seroconversion, and clinical cure over three years. These outcomes will help compare the effectiveness of different antiviral strategies. The study involves long-term monitoring of biological markers and clinical health to better understand how treatments influence HBV progression and patient prognosis.
CONDITIONS
Brief Title
Treatment and Prognosis of Patients With Chronic HBV Infection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with evidence of chronic HBV infection
- Aged between 18 and 79 years old
You will not qualify if you...
- Chronic liver injury mainly caused by autoimmune diseases, alcohol, drugs, or other reasons
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 - Up to 3 years
Participants receive antiviral therapy with pegylated interferon, nucleos(t)ide analogues, or a combination of both.
Visits every 3 to 6 months for blood tests and clinical assessments
Duration - Up to 3 years
Participants are followed with regular collection of serum, feces, urine, and liver samples as needed to evaluate clinical outcomes and antiviral treatment effects.
Visits every 3 to 6 months for sample collection and clinical evaluation
Trial Site Locations
Total: 1 location
1
Department of Infectious Disease, Xiangya Hospital, Central South University
Changsha, Hunan, China, 410008
Actively Recruiting
Research Team
Y
Yan Huang
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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