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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Third Affiliated Hospital, Sun Yat-Sen University
Sponsor:
Information provided by (Responsible Party):
Zhe-bin Wu, Third Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier:
NCT01627236
First received: June 10, 2012
Last updated: October 9, 2013
Last verified: August 2013
  Purpose

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 ]
    ALT,albumin,bilirubine,

  • 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

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

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

No publications provided

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
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Chronic
Digestive System Diseases
DNA Virus Infections
Enterovirus Infections
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Glucocorticoids
Methylprednisolone
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Gastrointestinal Agents
Hormones

ClinicalTrials.gov processed this record on October 23, 2014