Randomised Study Comparing Different Dosages of Rabbit ATG in Patients With SAA

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nagoya University
• Treatments: Thymoglobulin

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

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