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Observational clinical study on the dynamic changes of HBV RNA levels in patients with chronic hepatitis B and their correlation with treatment efficacy and prognosis outcomes

Observational clinical study on the dynamic changes of HBV RNA levels in patients with chronic hepatitis B and their correlation with treatment efficacy and prognosis outcomes

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400093879
Enrollment
Unknown
Registered
2024-12-13
Start date
2024-12-13
Completion date
Unknown
Last updated
2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic hepatitis B

Interventions

Observation group:None

Sponsors

Fifth Affiliated Hospital, Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.HBsAg positive greater than 6 months and HBV DNA positive, persistent or intermittent ALT / AST levels increased; 2.In HBV-infected patients over 14 years of age and under 65 years old; 3.Nucleoside (acid) analogues or interferon treatment in patients with CHB; 4.Voluntary participation in this study, and signed the informed consent form;

Exclusion criteria

Exclusion criteria: 1.Women who are pregnant or who are preparing for pregnancy and lactation; 2.Patients were unable or unwilling to follow the study protocol and complete the follow-up; 3.The patient is participating in other clinical trials and may affect data collection for this study; 4.Patients with concurrent HCV infection, HIV infection, liver cancer or cirrhosis, and autoimmune hepatitis; 5.Diseases associated with other major organs, such as severe heart disease or kidney disease; 6.There was a history of malignancy, including hepatocellular carcinoma, carcinoma in situ, and atypical hyperplastic nodules; 7.Suffers from mental illness; 8.Received corticosteroids, immunosuppressants, or chemotherapeutic agents within 6 months prior to enrollment;

Design outcomes

Primary

MeasureTime frame
HBeAg seroconversion rate;

Secondary

MeasureTime frame
HBsAg seroconversion rate, liver cancer and cirrhosis incidence;

Countries

China

Contacts

Public ContactZhongsi Hong

Fifth Affiliated Hospital, Sun Yat-Sen University

hongzhs@sysu.edu.cn+86 13926931110

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026