Randomised Study Comparing Different Dosages of Rabbit ATG in Patients With SAA
- Registration Number
- NCT01844635
- Lead Sponsor
- Nagoya University
- Brief Summary
The objective of this study is to evaluate the feasibility and effectiveness of immunosuppressive therapy (IST) using rabbit anti-thymocyte globulin (ATG) (Thymoglobuline, Genzyme) for patients with very severe aplastic anemia (VSAA) and severe aplastic anemia (SAA) as a primary therapy. The primary endpoint is the response rate (complete response (CR) + partial response (PR)) at day 180 after the start of IST. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 320
- Acquired aplastic anemia
- Age: younger than 70 years old
- Severity: SAA, VSAA.
- Interval between diagnosis and registration <6 months.
- Written informed consent from the caretakers and/or whenever possible consent from the patient.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2.5 mg/kg/day of Thymoglobulin for 5 days Thymoglobulin 2.5 mg/kg/day of Thymoglobulin for 5 days 3.5 mg/kg/day of Thymoglobulin for 5 days Thymoglobulin 3.5 mg/kg/day of Thymoglobulin for 5 days
- Primary Outcome Measures
Name Time Method Hematologic response (complete response (CR) or partial response (PR)) in patients with immunosuppressive therapy (IST) on day 180 after the start of IST. day 180 after the start of IST
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department of Pediatrics, Nagoya University Graduate School of Medicine
🇯🇵Nagoya, Aichi, Japan