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Impact of MASLD on hepatitis B virus infection, clinical outcomes, and prognosis — A prospective, multi-center, real-world study (Sail Plan).

Impact of MASLD on hepatitis B virus infection, clinical outcomes, and prognosis — A prospective, multi-center, real-world study (Sail Plan).

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400092651
Enrollment
Unknown
Registered
2024-11-21
Start date
2024-11-30
Completion date
Unknown
Last updated
2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic hepatitis B, Metabolic dysfunction-associated steatotic liver disease

Interventions

CHB+MASLD group:None

Sponsors

The first affiliated hospital of dalian medical university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Diagnostic Criteria for Chronic Hepatitis B (CHB): (1) Age = 18 years; (2) Meets the criteria outlined in the "Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2022 Version)": HBV DNA positive or HBsAg positive for over 6 months. 2. Diagnostic Criteria for Metabolic-Associated Steatotic Liver Disease (MASLD): (1) Age = 18 years; (2) Meets the criteria outlined in the "Guidelines for the Prevention and Treatment of Metabolic-Associated (Non-Alcoholic) Fatty Liver Disease (2024 Version)": Liver biopsy or abdominal imaging indicates fatty liver, along with the presence of at least one cardiovascular metabolic factor: ? Overweight/Obesity: BMI = 24.0 kg/m², waist circumference = 90 cm (male) and 85 cm (female), or exceeding body fat percentage; ? Hypertension: Blood pressure = 130/85 mmHg, or currently receiving antihypertensive treatment; ? Prediabetes or Type 2 Diabetes: Fasting blood glucose = 1.7 mmol/L, or 2-hour post-glucose load blood glucose = 7.8 mmol/L or HbA1c = 5.7%, or history of Type 2 Diabetes, or HOMA-IR = 2.5; ? Dyslipidemia: Fasting serum TG = 1.70 mmol/L, or currently receiving lipid-lowering medication; ? Low serum high-density lipoprotein: = 1.0 mmol/L (male) and 1.3 mmol/L (female), or currently receiving lipid-lowering medication. 3. Initial skin tissue is intact (acupuncture). 4. No medications affecting treatment outcomes have been used recently. 5. Informed consent obtained for this study.

Exclusion criteria

Exclusion criteria: 1. Combine other viral hepatitis (HCV, HDV, HEV, HIV), drug-induced hepatitis, autoimmune hepatitis, or genetic metabolic liver diseases; 2. History of excessive alcohol consumption (ethanol intake: males >210g/week, females >120g/week); 3. Individuals with cardiac, pulmonary, renal dysfunction, or multiple organ failure; 4. Post-organ transplantation individuals or those preparing for organ transplantation; 5. Exclude acupuncture research participants with comorbidities such as heart disease, implanted pacemaker, thromboembolic disease, malignant tumors, hematological diseases, dermatological conditions, or those within 14 days post-trauma, surgery, or interventional treatment; 6. Exclude mid-frequency therapy instrument research participants with severe hypertension, heart disease, pregnant women, individuals with pacemakers, hepatic hemangiomas, acute severe cholecystitis, cholangitis, or those with thromboembolic conditions; 7. Individuals with cognitive impairment, altered consciousness, or psychiatric disorders; 8. Pregnant or breastfeeding individuals; 9. Users of immunosuppressants or individuals planning to use other drugs with anti-HBV effects during the study; 10. Neutrophil count <0.5×10^9/L and/or platelet count <25×10^9/L; 11. Individuals allergic to interferon; 12. Other conditions deemed inappropriate by the investigator for enrollment.

Design outcomes

Primary

MeasureTime frame
Hepatitis B virology index;

Secondary

MeasureTime frame
metabolic indicators;

Countries

China

Contacts

Public ContactYing Zhu

the first affiliated hospital of dalian medical university

zhuyingsh52@126.com+86 180 9887 8999

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026