Health Condition 1: D60-D64- Aplastic and other anemias and other bone marrow failure syndromes Health Condition 2: null- Aplastic Anemia
Conditions
Interventions
Intervention1: Thymogam: Thymogam is a sterile, transparent aqueous solution containing Antithymocyte globulin. Thymogam is obtained by processing hyper-immune serum of horses immunized with human th
Sponsors
Bharat Serums and Vaccines Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Acquired aplastic anaemia 2. Age above 2 years 3. Hypocellular bone marrow- 4. With any severity of disease
Exclusion criteria
Exclusion criteria: a. History of cancer b. Creatinine > 2.5 times above the normal limit c. HIV positive d. Clonal disorder e. Pregnancy a. Participation in another investigational study within 30 days before the current study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete remission A.Transfusion independence B. Hb â?¥ 11 g/Dl C. Neutrophils 1.5 Ã? 109/L D. Platelets 100 Ã? 109/L.) ii. Partial remission A. Transfusion independence B. Hb â?¥ 8 g/dL C. Neutrophils0.5 Ã? 109/L D. Platelets 20 Ã? 109/L.) iii. Non responsive A. Transfusion dependence was taken as evidence of no response. Timepoint: Day 90 / Day 180 | — |
Secondary
| Measure | Time frame |
|---|---|
| i. Incidence/Time to relapse ii. Mortality Timepoint: Day 90/ Day 180 | — |
Countries
India
Contacts
Public ContactMs Najy Turakhia
Seth GS Medical College and KEM Hospital
Outcome results
None listed