A Clinical Research on Disease Progression and Intervention of Chronic HepatitisB

Hong Ren

Status

Unknown

Conditions

Hepatitis B, Chronic

Study type

Observational

Funder types

Other

Identifiers

NCT05057065

LS2021037

Details and patient eligibility

About

HBV(hepatitis B virus) with metabolic comorbidities may accelerate liver disease progression and increase the risk of HCC(Hepatocellular Carcinoma)development. It is reported combination of metabolic diseases and CHB is associated with substantially increased rates of liver cirrhosis and secondary liver-related events compared to CHB alone. Consequently, hepatitis B patients with metabolic comorbidities warrant particular attention in disease surveillance and evaluation of treatment indications.

Full description

Primary objective:

To evaluate the impact of metabolic disease on the progression of chronic hepatitis B

To observe HBsAg/HBeAg/HBV DNA changes /HBsAg seroconversion
To determine high rates of Liver Cirrhosis and Hepatocellular Carcinoma

Group 1 : CHB with diabetes Group 2 : CHB with hyperlipemia Group 3 : CHB without metabolic diseases

Study Duration (in months) 24 months

Enrollment

10,000 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

Chronic hepatitis B (positive HBsAg for at least 6 months prior to NA therapy start)
Patients on-treatment with NAs

Exclusion criteria

Treatment with immunosuppressors (including systemic corticosteroids) or anti-neoplastic treatment (including radiation therapy) <=6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study.
History of depression or uncontrolled psychiatric disorders
Subjects protected by law or not in a position to give consent