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A Clinical Research on Disease Progression and Intervention of Chronic HepatitisB

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05057065
Enrollment
10000
Registered
2021-09-27
Start date
2021-09-15
Completion date
2023-06-01
Last updated
2021-09-27

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

Conditions

Hepatitis B, Chronic

Keywords

HBV, metabolic diseases

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

Interventions

None listed

Sponsors

Hong Ren
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Efficacy of NAs therapy2 yearWe 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

MeasureTime frameDescription
Incidence of liver fibrosis and cirrhosis2 yearWe 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)

Countries

China

Contacts

Primary ContactHONG REN, Prof.
renhong0531@vip.sina.com8613983888786
Backup ContactDACHUAN CAI, Dr.
dachuancai@yahoo.com8613883596197

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026