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

NCT01627236 | Unknown

• 1 other identifier: zssywzb01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (6)

• survival rate

  eight weeks

• liver function

  ALT,albumin,bilirubine,

  eight weeks

• HBV-DNA

  eight weeks

• prothrombin activity

  eight weeks

• Child-Pugh degree

  eight weeks

• model for end-stage liver disease

  eight weeks

Secondary Outcomes (2)

• length of patient stay

  eight weeks

• hospitalization costs

  eight weeks

Study Arms (2)

glucocorticoid treatment group

EXPERIMENTAL

Drug: methylprednisolone

conventional treatment

NO INTERVENTION

Interventions

methylprednisolone DRUG

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

glucocorticoid treatment group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Third Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

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

Guangzhou, Guangdong, 020, China

RECRUITING

MeSH Terms

Interventions

Methylprednisolone

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Zhi-liang Gao, professor

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

  STUDY DIRECTOR

Central Study Contacts

Zhe-bin Wu, resident physician

CONTACT

13751743264; wzbice1982@sohu.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 10, 2012
• First Posted: June 25, 2012
• Study Start: December 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: November 1, 2014
• Last Updated: October 10, 2013

Record last verified: 2013-08

Locations

CN (1)