A Clinical Research on Disease Progression and Intervention of Chronic HepatitisB

September 15, 2021 updated by: Hong Ren

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

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400010
        • Recruiting
        • The 2nd affiliated Hospital of Chongqing Medical University
        • Contact:
        • Principal Investigator:
          • HONG REN, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Chronic hepatitis B patients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Hyperlipidemia
  • HBsAg(+) patients
  • TC>5.17mmol/L（200mg/dl）and（or）TG>2.3mmol/L（200mg/dl）
diabetes
  • HBsAg(+) patients
  • FPG>126 mg/dL(7.0 mmol/L)Fasting is defined as no caloric intake for at least 8 h.
CHB without metabolic disease
  • HBsAg(+) patients
  • without diabetes/ obesity/hyperlipidemia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of NAs therapy
Time Frame: 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.
2 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of liver fibrosis and cirrhosis
Time Frame: 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）
2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hong Ren

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 15, 2021

Primary Completion (ANTICIPATED)

September 1, 2022

Study Completion (ANTICIPATED)

June 1, 2023

Study Registration Dates

First Submitted

September 8, 2021

First Submitted That Met QC Criteria

September 15, 2021

First Posted (ACTUAL)

September 27, 2021

Study Record Updates

Last Update Posted (ACTUAL)

September 27, 2021

Last Update Submitted That Met QC Criteria

September 15, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LS2021037

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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