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

NCT ID: NCT05705141

Last Updated: 2024-03-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-30
• Study Completion Date: 2026-10-31

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.

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.

Conditions

Chronic Hepatitis b

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Combined metabolic syndrome

HBeAg-positive CHB patients with metabolic syndrome

No interventions assigned to this group

Uncombined with metabolic syndrome

HBeAg-positive CHB patients without combined MS

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role: lead

Responsible Party

Jie Li

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Jie Li, M.D., Ph.D

Role: CONTACT

lijier@sina.com

15863787910

Fajuan Rui

Role: CONTACT

ruifajuan@163.com

18353185039

Other Identifiers

CDL2302

Identifier Type: -

Identifier Source: org_study_id