A Clinical Research on Disease Progression and Intervention of Chronic HepatitisB

• Conditions: Hepatitis B, Chronic

• Registration Number: NCT05057065
• Lead Sponsor: Hong Ren

Brief Summary

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.

Detailed 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

Study Timeline

• Status Verified: 2021-09
• Study First Submitted: 2021-09-08
• Study Start: 2021-09-15
• Study First Submitted QC: 2021-09-15
• Last Update Submitted: 2021-09-15
• Study First Posted: 2021-09-27
• Last Update Posted: 2021-09-27
• Primary Completion: 2022-09-01
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy of NAs therapy	2 year	We will follow up patients every six months and all patients with a history of hepatitis B will be tested for HBsAg(+) and HBD-DNA.The curative effect was evaluated by observing the changes of serological indexes.

Secondary Outcome Measures

Name	Time	Method
Incidence of liver fibrosis and cirrhosis	2 year	We will follow up patients every six months and all patients() with a history of hepatitis B will be tested for FibroScan. The influence of metabolic diseases on the progression of hepatitis B was evaluated by comparing the changes of liver hardness between groups（Hyperlipidemia，Diabetes and CHB without metabolic disease）

Trial Locations

Locations (1)

The 2nd affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China