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

NCT ID: NCT01627236

Last Updated: 2013-10-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2014-11-30

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.

Conditions

Severe Acute Exacerbation of Chronic Hepatitis B

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

glucocorticoid treatment group

Group Type: EXPERIMENTAL

methylprednisolone

Intervention Type: DRUG

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

conventional treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

methylprednisolone

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Third Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: lead

Responsible Party

Zhe-bin Wu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhi-liang Gao, professor

Role: STUDY_DIRECTOR

Deparment of Infectious Diseases, the Third Affiliated Hospital of Sun Yat-sen University

Locations

Deparment of Infectious Diseases, the Second Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhe-bin Wu, resident physician

Role: CONTACT

wzbice1982@sohu.com

13751743264

Facility Contacts

Zhe-bin Wu, resident physician

Role: primary

wzbice1982@sohu.com

13751743264

Other Identifiers

zssywzb01

Identifier Type: -

Identifier Source: org_study_id