Evaluation of safety and protective efficacy of fulminant hepatitis to abatacept treatment of patients with HBV-related severe hepatitis.-Pilot Study
Phase 2
- Conditions
- HBV-related acute severe hepatitis
- Registration Number
- JPRN-UMIN000025725
- Lead Sponsor
- Hiroshima university hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
Not provided
Exclusion Criteria
1) PT less than 10% 2) PT 61% or more, and either AST or ALT is on a downward trend 3) Hepatic encephalopathy 2 deg rees or more 4) Patients with autoimmune hepatitis 5) Patients with a history of hypersensitivity to orencia 6) Patients with severe infection 7) In addition, patients judg ed unsuitable for participation in this study by research doctor.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Ratio of patient with severe hepatitis improved one week after treatment (Ratio of patient that PT was restored than 70%)
- Secondary Outcome Measures
Name Time Method Period of ALT being normalized Safety (moniterd clinical and laboratory evaluation)