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

NCT05705141 | Not Yet Recruiting

• 1 other identifier: CDL2302
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Chronic Hepatitis b

Keywords

Chronic Hepatitis b; metabolic syndrome; Antiviral treatment

Outcome Measures

Primary Outcomes (1)

• Difference of HBeAg seroconversion rate between HBeAg-positive CHB patients with and without metabolic syndrome after 144 weeks of first-line oral antiviral treatment

  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 Outcomes (2)

• 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

  48 weeks，96 weeks，144 weeks

Study Arms (2)

Combined metabolic syndrome

HBeAg-positive CHB patients with metabolic syndrome

Uncombined with metabolic syndrome

HBeAg-positive CHB patients without combined MS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Any gender, age 18-65 years.
• 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.
• 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.
• voluntarily sign the informed consent form.

You may not qualify if:

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

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

MeSH Terms

Conditions

Hepatitis B, Chronic; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Jie Li, M.D., Ph.D

CONTACT

15863787910; lijier@sina.com

Fajuan Rui

CONTACT

18353185039; ruifajuan@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 21, 2023
• First Posted: January 30, 2023
• Study Start: April 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 19, 2024

Record last verified: 2024-03