A prospective randomized dose comparison multicenter study of the rabbit anti-thymocyte globulin (thymoglobulin, Genzyme) for patients with severe and very severe aplastic anemia
Not Applicable
- Conditions
- Acquired Aplastic Anemia
- Registration Number
- JPRN-UMIN000011134
- Lead Sponsor
- agoya University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 222
Inclusion Criteria
Not provided
Exclusion Criteria
None
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint is the response rate (complete response (CR) + partial response (PR)) at day 180 after the start of IST.
- Secondary Outcome Measures
Name Time Method Secondary endpoints include evaluation of the presence and frequency of Epstein-Barr virus (EBV)-reactivation and EBV-associated lymphoproliferative disorder (EBV-LPD), Cytomegalovirus(CMV)-reactivation and CMV associated diseases, the response rate (CR+PR) on Day 360 after the start of IST, relapse rate and overall survival.