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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2013 by Third Affiliated Hospital, Sun Yat-Sen University.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
Zhe-bin Wu, Third Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier:
First received: June 10, 2012
Last updated: October 9, 2013
Last verified: August 2013
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.

Condition Intervention
Severe Acute Exacerbation of Chronic Hepatitis B
Drug: methylprednisolone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Third Affiliated Hospital, Sun Yat-Sen University:

Primary Outcome Measures:
  • survival rate [ Time Frame: eight weeks ] [ Designated as safety issue: No ]
  • liver function [ Time Frame: eight weeks ] [ Designated as safety issue: No ]

  • HBV-DNA [ Time Frame: eight weeks ] [ Designated as safety issue: No ]
  • prothrombin activity [ Time Frame: eight weeks ] [ Designated as safety issue: No ]
  • Child-Pugh degree [ Time Frame: eight weeks ] [ Designated as safety issue: No ]
  • model for end-stage liver disease [ Time Frame: eight weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • length of patient stay [ Time Frame: eight weeks ] [ Designated as safety issue: No ]
  • hospitalization costs [ Time Frame: eight weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: December 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: glucocorticoid treatment group Drug: methylprednisolone
methylprednisolone 1mg/kg intravenous drip qd,for 3 days glucocorticoid
No Intervention: conventional treatment


Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01627236

Contact: Zhe-bin Wu, resident physician 13751743264 wzbice1982@sohu.com

China, Guangdong
Deparment of Infectious Diseases, the Second Affiliated Hospital of Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 020
Contact: Zhe-bin Wu, resident physician    13751743264    wzbice1982@sohu.com   
Principal Investigator: Zhe-bin Wu, resident physician         
Sponsors and Collaborators
Third Affiliated Hospital, Sun Yat-Sen University
Study Director: Zhi-liang Gao, professor Deparment of Infectious Diseases, the Third Affiliated Hospital of Sun Yat-sen University
  More Information

Responsible Party: Zhe-bin Wu, Principal Investigator, Third Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT01627236     History of Changes
Other Study ID Numbers: zssywzb01 
Study First Received: June 10, 2012
Last Updated: October 9, 2013
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Chronic
DNA Virus Infections
Digestive System Diseases
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Virus Diseases
Methylprednisolone Hemisuccinate
Methylprednisolone acetate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Peripheral Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 27, 2016