Efficacy of Short-term Immunosuppressive Therapy and Anti-allergenic Therapy in Severe Acute Exacerbation of Chronic Hepatitis B

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01627236

Enrollment

120

Registered

2012-06-25

Start date

2012-12-31

Completion date

2014-11-30

Last updated

2013-10-10

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

Conditions

Severe Acute Exacerbation of Chronic Hepatitis B

Brief summary

The investigators will investigate the clinicopathological features of chronic hepatitis B patients with severe exacerbation selected by uniform criteria, and treated with early introduction or reintroduction of corticosteroids and anti-allergenic therapy, in order to clarify the benefits and limitations of the effects of corticosteroids and anti-allergenic therapy for amelioration of clinically severe exacerbation of chronic hepatitis B. The investigators also observe the immune index in the change before and after the treatment, in order to searching for some prognostic index.

Interventions

DRUGmethylprednisolone

methylprednisolone 1mg/kg intravenous drip qd，for 3 days glucocorticoid

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

* serum hepatitis B surface antigen(HBsAg) positive for at least 6 months; * All patients had a poor general condition, manifested as general malaise, fatigue, jaundice and so on; * serum T-Bil of 85.5 mmol/L or more; or serum T-Bil rises 17.1 mmol/L or more per day; or PTA of less than 60%; * serum ALT of 20 times or more the ULN.

Exclusion criteria

* superinfection or co-infection with hepatitis A, C, D, E, cytomegalovirus and HIV, or Epstein-Barr virus; * other liver diseases such as alcoholic liver disease, drug-induced hepatitis, Wilson disease and autoimmune hepatitis; * ascites or gastrointestinal bleeding or peptic ulcer or esophageal varix by electronic gastroscope examination; * decompensated liver cirrhosis; * severe bacterial or fungal infections; * a history of diabetes or cardiac disease or hypertension or nephrosis.

Design outcomes

Primary

Measure	Time frame	Description
model for end-stage liver disease	eight weeks	—
prothrombin activity	eight weeks	—
Child-Pugh degree	eight weeks	—
survival rate	eight weeks	—
liver function	eight weeks	ALT,albumin,bilirubine,
HBV-DNA	eight weeks	—

Secondary

Measure	Time frame
hospitalization costs	eight weeks
length of patient stay	eight weeks

Countries

China

Contacts

Primary ContactZhe-bin Wu, resident physician

wzbice1982@sohu.com13751743264

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026