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

October 9, 2013 updated by: Zhe-bin Wu, Third Affiliated Hospital, Sun Yat-Sen University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 020
        • Recruiting
        • Deparment of Infectious Diseases, the Second Affiliated Hospital of Sun Yat-sen University
        • Contact:
        • Principal Investigator:
          • Zhe-bin Wu, resident physician

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: conventional treatment
Experimental: glucocorticoid treatment group
Drug: methylprednisolone
methylprednisolone 1mg/kg intravenous drip qd，for 3 days glucocorticoid

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
length of patient stay
Time Frame: eight weeks
eight weeks
hospitalization costs
Time Frame: eight weeks
eight weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Third Affiliated Hospital, Sun Yat-Sen University

Investigators

  • Study Director: Zhi-liang Gao, professor, Deparment of Infectious Diseases, the Third Affiliated Hospital of Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Anticipated)

August 1, 2014

Study Completion (Anticipated)

November 1, 2014

Study Registration Dates

First Submitted

June 10, 2012

First Submitted That Met QC Criteria

June 20, 2012

First Posted (Estimate)

June 25, 2012

Study Record Updates

Last Update Posted (Estimate)

October 10, 2013

Last Update Submitted That Met QC Criteria

October 9, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • zssywzb01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Severe Acute Exacerbation of Chronic Hepatitis B

Clinical Trials on methylprednisolone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Liberia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe