The Effect of Metabolic Syndrome on Antiviral Response in People With Chronic Hepatitis B

March 16, 2024 updated by: Jie Li, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

The Effect of Metabolic Syndrome on Antiviral Response in People With Chronic Hepatitis B: a Prospective, Multicenter, Real-world Study

Chronic hepatitis B (CHB) affects an estimated 292 million people, and causes approximately 800,000 people deaths per year from liver-related complications including cirrhosis and hepatocellular carcinoma, remaining a major global public health issue.Meanwhile, the rising incidence of metabolic syndrome (MetS) is another grim health burden. Combined MetS affects the metabolic function of hepatocytes, which are responsible for providing HBV replication. Antiviral therapy is an effective measure to reduce the risk of cirrhosis and liver cancer in patients with chronic CHB. Combined MetS may affect the antiviral efficacy in patients with CHB.This prospective observational study examines the differences in HBeAg serological conversion rates between HBeAg-positive CHB patients with and without MS who received first-line oral antivirals for 144 weeks.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Chronic hepatitis B (CHB) affects an estimated 292 million people, and causes approximately 800,000 people deaths per year from liver-related complications including cirrhosis and hepatocellular carcinoma, remaining a major global public health issue.Meanwhile, the rising incidence of metabolic syndrome (MetS) is another grim health burden. Combined MetS affects the metabolic function of hepatocytes, which are responsible for providing HBV replication. Antiviral therapy is an effective measure to reduce the risk of cirrhosis and liver cancer in patients with chronic CHB. Combined MetS may affect the antiviral efficacy in patients with CHB.This prospective observational study examines the differences in baseline clinical characteristics and the value of predicting HBeAg seroconversion rates at 144 weeks in HBeAg-positive CHB patients with and without MetS, and examines the differences in HBeAg seroconversion rates, degree of HBsAg decline, biochemical recurrence rates and HBV DNA negativity between HBeAg-positive CHB patients with and without MetS at 48 weeks, 96 weeks and 144 weeks of treatment.

Study Type

Observational

Enrollment (Estimated)

1000

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

  • Name: Jie Li, M.D., Ph.D
  • Phone Number: 15863787910
  • Email: lijier@sina.com

Study Contact Backup

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

HBeAg-positive CHB patients with and without metabolic syndrome received first-line oral antiviral therapy

Description

Inclusion Criteria:

  1. Any gender, age 18-65 years.
  2. CHB diagnosis in accordance with the 2019 China Guidelines for the Prevention and Treatment of Chronic Hepatitis B; metabolic syndrome can be diagnosed with 3 or more of the following: 1) abdominal obesity: waist circumference ≥ 90 cm in men and ≥ 85 cm in women; 2) increased blood pressure: blood pressure ≥ 130/85 mmHg and/or diagnosed and treated hypertension; 3) dyslipidemia: fasting triglycerides ≥ 1.7 mmol/L, fasting HDL-C <1.04mmol/L, or diagnosed and medically treated dyslipidaemia; 4) Hyperglycaemia: fasting blood glucose ≥6.1mmol/L or 2 hours post sugar load blood glucose ≥7.8mmol/L, and/or diagnosed and treated diabetes mellitus.
  3. HBeAg-positive, meeting the indications for antiviral treatment in our 2019 Guidelines for the Prevention and Treatment of Chronic Hepatitis B and ready to receive first-line antiviral medication.
  4. voluntarily sign the informed consent form.

Exclusion Criteria:

  1. Patients with co-infection with hepatitis A virus, hepatitis C virus, hepatitis E virus or hepatitis D virus
  2. Patients with combined autoimmune hepatitis, primary biliary cholangitis or primary sclerosing cholangitis
  3. Patients with co-morbid hereditary metabolic liver disease such as hepatomegaly, hepatic glycogen accumulation disorder
  4. Patients with co-morbid primary liver cancer or other types of cancer; mental illness, severe cardiopulmonary impairment
  5. Patients with alcohol abuse (≥210 g alcohol/week for men and ≥140 g alcohol/week for women)
  6. Patients who have undergone liver transplantation or other organ transplantation.
  7. Have received antiviral treatment within six months prior to enrolment.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Combined metabolic syndrome
HBeAg-positive CHB patients with metabolic syndrome
Uncombined with metabolic syndrome
HBeAg-positive CHB patients without combined MS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference of HBeAg seroconversion rate between HBeAg-positive CHB patients with and without metabolic syndrome after 144 weeks of first-line oral antiviral treatment
Time Frame: 144 weeks
Difference of HBeAg seroconversion rate between HBeAg-positive CHB patients with and without metabolic syndrome after 144 weeks of first-line oral antiviral treatment
144 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Baseline clinical characteristics of HBeAg-positive CHB patients with and without metabolic syndrome, and the value of predicting HBeAg seroconversion rate at 144 weeks
Time Frame: 144 weeks
Baseline clinical characteristics of HBeAg-positive CHB patients with and without metabolic syndrome, and the value of predicting HBeAg seroconversion rate at 144 weeks
144 weeks
Differences in rates of HBeAg seroconversion, HBsAg decline, biochemical relapse, and HBV DNA negativity between HBeAg positive CHB patients with and without metabolic syndrome treated for 48, 96, and 144 weeks
Time Frame: 48 weeks，96 weeks，144 weeks
Differences in rates of HBeAg seroconversion, HBsAg decline, biochemical relapse, and HBV DNA negativity between HBeAg positive CHB patients with and without metabolic syndrome treated for 48, 96, and 144 weeks
48 weeks，96 weeks，144 weeks

Collaborators and Investigators

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

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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 (Estimated)

April 1, 2024

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

January 21, 2023

First Submitted That Met QC Criteria

January 21, 2023

First Posted (Actual)

January 30, 2023

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 16, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDL2302

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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