drugset / Trial / NCT01530555

Prospective Phase II Study of Rabbit Antithymocyte Globulin (ATG, Thymoglobuline®, Genzyme) With Ciclosporin for Patients With Acquired Aplastic Anaemia

NCT01530555

NaSingle-groupOpen-labelTreatment

Summary

To assess the tolerability and efficacy of rabbit antithymocyte globulin (ATG, Thymoglobuline®) with ciclosporin (CSA) in the first line treatment of patients with acquired severe aplastic anaemia (SAA), and patients with non-severe aplastic anaemia (NSAA) and who are transfusion dependent. To compare the response rate of the combination of rabbit ATG (Thymoglobuline® and CSA from this pilot study with the response rate observed in a series of matched AA patients; treated after 1994 with the combination of horse ATG (Lymphoglobuline®) and CSA; obtained from the EBMT database (comparative study).

Timeline

Start
2008-04
Primary completion
2013-07
Completion
2013-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclosporine Peptide 5 mg/kg Oral
Subject Thymoglobulin Protein / enzyme biologic 3.75 mg/kg Intravenous