Treatment of Aplastic Anemia

Not Applicable

• Conditions: Health Condition 1: null- Refractory Severe Aplastic Anemia

• Registration Number: CTRI/2013/03/003480
• Lead Sponsor: Principal Investigator Research Fund

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Other (Terminated)
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

1.Acquired aplastic anaemia

2.Age above 18 years

3.Patient / Legally Acceptable Representative able to provide informed consent

4.Hypocellular bone marrow- < 25%

5.With any severity of disease as defined below:

A. Not Severe Aplastic Anaemia

i. Hb <10g/dL

ii. ANC <1,500 cells/mm3

iii. PL <100 Ã? 109/L

B. Severe Aplastic Anaemia

i. Neutrophil count 0.5 x 109/l

ii. Platelets < 20 x 109/l

iii. Reticulocytes < 20 x109/l

C. Very Severe Aplastic Anaemia

i.If the ANC is < 200 cells/mm3

6.Prior treatment with any of the standard treatment Equine/rabbit Antithymocyte Globulin (ATG) and or cyclosporine or other drugs danazol, mycophenolate, prednisolone etc.

Exclusion Criteria

History of cancer, renal failure, HIV positive status, Clonal disorders, pregnancy, participation in another investigational study 30-days before the current study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recovery of Aplastic anemiaTimepoint: At 6 months

Secondary Outcome Measures

Name	Time	Method
Time to relapse and mortalityTimepoint: 180 days