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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05057065
Other study ID # LS2021037
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 15, 2021
Est. completion date June 1, 2023

Study information

Verified date September 2021
Source The Second Affiliated Hospital of Chongqing Medical University
Contact HONG REN, Prof.
Phone 8613983888786
Email renhong0531@vip.sina.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 10000
Est. completion date June 1, 2023
Est. primary completion date September 1, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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


Related Conditions & MeSH terms


Locations

Country Name City State
China The 2nd affiliated Hospital of Chongqing Medical University Chongqing Chongqing

Sponsors (1)

Lead Sponsor Collaborator
Hong Ren

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Efficacy of NAs therapy 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. 2 year
Secondary Incidence of liver fibrosis and cirrhosis 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) 2 year
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