Antithymocyte globulin usefullness in treatment of low blood cell count

Phase 4

Completed

• Conditions: Health Condition 1: D60-D64- Aplastic and other anemias and other bone marrow failure syndromesHealth Condition 2: null- Aplastic Anemia

• Registration Number: CTRI/2012/03/002498
• Lead Sponsor: Bharat Serums and Vaccines Ltd

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: Completed
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Acquired aplastic anaemia

2.Age above 2 years

3.Hypocellular bone marrow- < 25%

4.With any severity of disease

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complete remission <br/ ><br>A.Transfusion independence <br/ ><br>B. Hb â?¥ 11 g/Dl <br/ ><br>C. Neutrophils 1.5 Ã? 109/L <br/ ><br>D. Platelets 100 Ã? 109/L.) <br/ ><br> <br/ ><br>ii. Partial remission <br/ ><br>A.Transfusion independence <br/ ><br>B.Hb â?¥ 8 g/dL <br/ ><br>C.Neutrophils0.5 Ã? 109/L <br/ ><br>D.Platelets 20 Ã? 109/L.) <br/ ><br> <br/ ><br>iii. Non responsive <br/ ><br>A. Transfusion dependence was taken as evidence of no response. <br/ ><br>Timepoint: Day 90 / Day 180

Secondary Outcome Measures

Name	Time	Method
i.Incidence/Time to relapse <br/ ><br>ii. Mortality <br/ ><br>Timepoint: Day 90/ Day 180