Chronic Hepatitis B
Conditions
Interventions
Combined Metabolic Syndrome group:None
HBV DNA positive initial treatment group:None
Renal insufficiency group:None
Sponsors
Hebei Medical University Third Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Adults aged 18 years and above; 2. CHB patients should meet the following: 2.1 Have written evidence of a diagnosis of HBeAg-positive or HBeAg-negative CHB and/or meet any of the following: (1) HBsAg positive or HBV DNA positive for >=6 months; (2) HBsAg positive, total hepatitis B core antibody (HBcAb) positive, IgM-HBcAb negative, HBsAb negative; 2.2 Screening period serum ALT level of 1×ULN =12.0kPa; 1xULN=17.0kPa) (4) Blood biochemical tests show decreased albumin levels (3s compared to controls): (5) Routine blood tests show platelet count =24.0kg/m^2, or waist circumference >=90cm (male) and 85cm (female): (2) Elevated arterial blood pressure/hypertension: Arterial blood pressure >=130/85 mmHg, or receiving antihypertensive medication: (3) Prediabetes or type 2 diabetes: fasting blood glucose >=6.1 mmol/L, or blood glucose > 2 hours after glucose loading = 7.8 mmol/L or HbA1c > = 5.7%, or history of type 2 diabetes, or insulin resistance index > 2.5; (4) Elevated TG: fasting serum triglycerides >=1.70 mmoIL, or those currently receiving lipid-lowering medications; (5) Reduction of high-density lipoprotein cholesterol: serum high-density lipoprotein < = 1.0 mmol/L (males) and 1.3 mmol/L (females), or patients currently receiving lipid-lowering medications.
Exclusion criteria
Exclusion criteria: 1.History of liver failure, liver transplantation or hepatocellular carcinoma. 2.Prior receipt of other solid organ or bone marrow transplantation. 3.Patients with severe hematological, cardiovascular, respiratory or neurological diseases, bone diseases or multiple fractures, severe renal disease (eGFR<15mL/min/1.73m^2), as well as those who have received radiotherapy, chemotherapy or immunomodulatory therapy for cancer or other severe illnesses. 4.Currently participating in other clinical studies of similar NA drugs. 5.Any other conditions that render the subject unsuitable for this study as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The complete virological response rate of each cohort at 48 weeks; | — |
Secondary
| Measure | Time frame |
|---|---|
| Event Outcomes;ALT normalization rate;The complete virological response rate at 24 weeks;Incidence of adverse events;HBsAg negative conversion and serum conversion; | — |
Countries
China
Contacts
Public ContactYuemin Nan
Hebei Medical University Third Hospital
Outcome results
None listed