Back to resultsEfficacy of Short-term Immunosuppressive Therapy and Anti-allergenic Therapy in Severe Acute Exacerbation of Chronic Hepatitis B
Primary Purpose
Severe Acute Exacerbation of Chronic Hepatitis B
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
methylprednisolone
Sponsored by
About this trial
This is an interventional treatment trial for Severe Acute Exacerbation of Chronic Hepatitis B
Eligibility 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.
Sites / Locations
- Deparment of Infectious Diseases, the Second Affiliated Hospital of Sun Yat-sen UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
glucocorticoid treatment group
conventional treatment
Arm Description
Outcomes
Primary Outcome Measures
survival rate
liver function
ALT,albumin,bilirubine,
HBV-DNA
prothrombin activity
Child-Pugh degree
model for end-stage liver disease
Secondary Outcome Measures
length of patient stay
hospitalization costs
Full Information
NCT ID
NCT01627236
First Posted
June 10, 2012
Last Updated
October 9, 2013
Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
1. Study Identification
Unique Protocol Identification Number
NCT01627236
Brief Title
Efficacy of Short-term Immunosuppressive Therapy and Anti-allergenic Therapy in Severe Acute Exacerbation of Chronic Hepatitis B
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Unknown status
Study Start Date
December 2012 (undefined)
Primary Completion Date
August 2014 (Anticipated)
Study Completion Date
November 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Acute Exacerbation of Chronic Hepatitis B
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
glucocorticoid treatment group
Arm Type
Experimental
Arm Title
conventional treatment
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
methylprednisolone
Intervention Description
methylprednisolone 1mg/kg intravenous drip qd，for 3 days glucocorticoid
Primary Outcome Measure Information:
Title
survival rate
Time Frame
eight weeks
Title
liver function
Description
ALT,albumin,bilirubine,
Time Frame
eight weeks
Title
HBV-DNA
Time Frame
eight weeks
Title
prothrombin activity
Time Frame
eight weeks
Title
Child-Pugh degree
Time Frame
eight weeks
Title
model for end-stage liver disease
Time Frame
eight weeks
Secondary Outcome Measure Information:
Title
length of patient stay
Time Frame
eight weeks
Title
hospitalization costs
Time Frame
eight weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhe-bin Wu, resident physician
Phone
13751743264
Email
wzbice1982@sohu.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhi-liang Gao, professor
Organizational Affiliation
Deparment of Infectious Diseases, the Third Affiliated Hospital of Sun Yat-sen University
Official's Role
Study Director
Facility Information:
Facility Name
Deparment of Infectious Diseases, the Second Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhe-bin Wu, resident physician
Phone
13751743264
Email
wzbice1982@sohu.com
First Name & Middle Initial & Last Name & Degree
Zhe-bin Wu, resident physician
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Short-term Immunosuppressive Therapy and Anti-allergenic Therapy in Severe Acute Exacerbation of Chronic Hepatitis B
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