The efficacy and safety of treating early phase of acute severe hepatitis B or ACLF with Methylprednisolone: a random controlled trial

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-12002741

Enrollment

Unknown

Registered

2012-11-20

Start date

2011-07-01

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

liver disease

Interventions

GC:Methylprednisolone and conventional therapy

control:Methylprednisolone and conventional therapy

Eligibility

Sex/Gender

All

Age

16 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. aged 18-65 years old; 2. HBsAg (positive), HBV-DNA>500copies/ml; 3. TBIL>171umol/l; 4. ALT>1000U/L; 5. PTA>20%, PTA1.5, INR<3.

Exclusion criteria

Exclusion criteria: 1. liver cirrhosis or determined by ultrasound scan; 2. encephalopathy phase III or phase IV; 3. upper gastrointestinal hemorrhage or peptic ulcer disease; 4. superinfection or co-infection with HIV, hepatitis A, C, D, E; 5. a history of diabetes, hypertension, other cardiac or kidney diseases; 6. bacterial or fungal infections(except spontaneous peritonitis); 7. caused by autoimmune diseases, alcohol, wilsons diseaseBudd-Chiari syndrome, lymphoma, acute intoxication (direct cellular toxicity of mushroom, fish bile or p-acetamidophenol)(DILI not included); 8. symptoms of Shock or DIC; 9. pregnancy; 10. concurrent malignant tumor or a history of tumor; 11. drug addiction; 12. past or experiencing other clinical trial.

Design outcomes

Primary

Measure	Time frame
Survival rate;	—

Secondary

Measure	Time frame
live function;INR;PTA;complication incidence rate;length of hospital stay;	—

Countries

China

Contacts

Public ContactMing Shao

jszygr@163.com+86 13951666659

Outcome results

None listed

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