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Not yet recruitingNCT05705141Updated Mar 19, 2024

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

An observational study in Chronic Hepatitis b, sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-03-19.

Sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Chronic Hepatitis b

Keywords

  • Chronic Hepatitis b
  • metabolic syndrome
  • Antiviral treatment
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
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

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

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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Combined metabolic syndrome

    HBeAg-positive CHB patients with metabolic syndrome

  • Uncombined with metabolic syndrome

    HBeAg-positive CHB patients without combined MS

05

What researchers measure

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

    Time frame: 144 weeks

Secondary outcomes

  1. Baseline clinical characteristics of HBeAg-positive CHB patients with and without metabolic syndrome, and the value of predicting HBeAg seroconversion rate at 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

    Time frame: 144 weeks

  2. 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

    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

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT05705141
Lead sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Responsible party
Jie Li (Principal Investigator, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School) — Principal investigator
First posted
Jan 30, 2023
Start date
Apr 2024 (estimated)
Primary completion
Aug 2026 (estimated)
Completion
Oct 2026 (estimated)
Last update
Mar 19, 2024

Study contacts

Jie Li, M.D., Ph.D
Contact
lijier@sina.com
15863787910
Fajuan Rui
Contact
ruifajuan@163.com
18353185039

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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