The study of glucocorticoid used for preventing occurrence of liver failure in patients with severe acute exacerbation of chronic hepatitis B

A multicenter, randomized, open lable, parallel controlled clinical study of glucocorticoid used for preventing occurrence of liver failure in patients with severe acute exacerbation of chronic hepatitis B

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-12002257

Enrollment

Unknown

Registered

2012-04-22

Start date

2012-06-01

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

Viral Hepatitis B

Interventions

High-dose group:Methylprednisolone 240mg/d

Low-dose group:Methylprednisolone 40mg/d

Control group:Nil

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Male and female patients aged 18 to 65 with chronic hepatitis B or HBsAg positive for more than 6 months, and now HBsAg and (or) HBV DNA remained positive.The signs and symptoms that patients had within 15 days listed b-elow: 1. Nausea, vomiting and other gastrointestinal symptoms were serious; 2. Serum total bilirubin had increased rapidly, >=17.1umol/L daily; 3. Prothrombin activity (PTA)> 30%; 4. There were no ascites and obvious cir-rhosis By B-ultrasound checked; 5. Without any of the following complications: gastrointestinal tract, intracranial and other organs bleeding; bacterial or fungal infections; liverencephalopathy; hepatorenal syndrome.

Exclusion criteria

Exclusion criteria: 1. The virus that was detected from these patients had resistance to nucleoside or nucleotide; 2. The patients were receiving chemotherapy and immunosuppressive therapy; 3. Concurrent viral infection,including HAV,HEV; 4. Combined with autoimmune liver disease (including AIH, PBC and PSC); 5. Combined with HCV-infected patients; 6. Combined with HIV infected patients; 7. Patients with primary hepatocellular carcinoma; 8. Pregnancy patients; 9. Existence of active peptic ulcer and other glucocorticoid use in patients with contraindications; 10. Patients with serious diseases of heart, brain, kidney and other vital organs that influence the judgement of the efficacy in short term.

Design outcomes

Primary

Measure	Time frame
Total bilirubin;Prothrombin time;international normalized ratio of Prothrombin time;Prothrombin activity;Alanine aminotransferase;WBC;	—

Secondary

Measure	Time frame
serum creatine;Blood urea nitrogen;Potassium;HBV-DNA;Immunoglobulin;	—

Countries

China

Contacts

Public ContactWeijiang Ye

ywjhzsh@hz.cn+86 13355716797

Outcome results

None listed

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