A Clinical Research on Disease Progression and Intervention of Chronic HepatitisB

Hepatitis B, Chronic Clinical Trial

Official title:

Disease Progression and Intervention of Chronic HepatitisB Based on Diabetes and Hyperlipidemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05057065
• Other study ID #: LS2021037
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Disease Progression
• Hepatitis B
• Hepatitis B, Chronic

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