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

Severe Acute Exacerbation of Chronic Hepatitis B Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01627236
• Other study ID #: zssywzb01
• Status: Recruiting
• Phase: N/A
• First received: June 10, 2012
• Last updated: October 9, 2013
• Start date: December 2012
• Est. completion date: November 2014

Study information

• Verified date: August 2013
• Source: Third Affiliated Hospital, Sun Yat-Sen University
• Contact: Zhe-bin Wu, resident physician
• Phone: 13751743264
• Email: wzbice1982[@]sohu.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: November 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic
• Severe Acute Exacerbation of Chronic Hepatitis B

Intervention

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

Locations

Country	Name	City	State
China	Deparment of Infectious Diseases, the Second Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Third Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	survival rate		eight weeks	No
Primary	liver function	ALT,albumin,bilirubine,	eight weeks	No
Primary	HBV-DNA		eight weeks	No
Primary	prothrombin activity		eight weeks	No
Primary	Child-Pugh degree		eight weeks	No
Primary	model for end-stage liver disease		eight weeks	No
Secondary	length of patient stay		eight weeks	No
Secondary	hospitalization costs		eight weeks	No