drugset / Trial / NCT02028416

Comparison of Two Different Doses of Rabbit ATG-Fresenius With Cyclosporin in the Treatment of Acquired Aplastic Anaemia

NCT02028416

RandomizedParallel-groupOpen-labelTreatment

Summary

Acquired Aplastic anemia is one of the most frequent reason of bone marrow failure in East (Pakistan). * The first treatment option is Allogenic Bone Marrow transplantation which is an expansive treatment option and also require a full matched HLA identical donor, hence hardly 25% of our affected patients get opportunity for BMT. * The second line treatment option caters a large chunk of patients (severe and non-severe AA) along with those who lack HLA identical donor. Previously many protocols had been used in past for ATG+CsA Treatment, this treatment protocol especially addresses the two different regimens of ATG to study its efficacy, durability and long-term effects. Following doses would be used: * CsA+ATG @ 10mg/kg for 3 days * CsA+ATG @ 10mg/kg for 5 days

Timeline

Start
2013-09
Primary completion
2017-12
Completion
2017-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Thymoglobulin Protein / enzyme biologic 10 mg/kg Other

Indications