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A Multicenter Investigation of Recombinant Human Thrombopoietin (rhTPO) Combining Cyclosporin A Versus Cyclosporin A in Management of Steroid-Resistant/Relapsed Immune Thrombocytopenia （ITP）

Immune Thrombocytopenia Clinical Trial

Official title:
Recombinant Human Thrombopoietin (rhTPO) Combining Cyclosporin A Versus Cyclosporin A in Management of Steroid-Resistant/Relapsed Immune Thrombocytopenia （ITP）

Clinical Trial Summary

The project was undertaking by Qilu Hospital of Shandong University and other 5 well-known hospitals in China. In order to report the efficacy and safety of recombinant human thrombopoietin combining with cyclosporin A for the treatment of adults with refractory immune thrombocytopenia (ITP), compared to cyclosporin A monotherapy.

Clinical Trial Description

The investigators are undertaking a parallel group, multicenter, randomized controlled trial of 120 steroid-resistant/relapsed ITP adult patients from 6 medical centers in China. One part of the participants are randomly selected to receive recombinant human thrombopoietin (given subcutaneously at a dose of 300 Units/kg for 14 consecutive days, following with a flexible dosage depending on platelet count until the 29th day), combining with cyclosporin A (given orally at a dose of 1.5-2.0mg/kg twice daily for 3 consecutive months, adjusted to maintain serum levels between 200-400 ng/ml and tapered by 50 mg/d per week if patients achieved a complete response). The others are selected to receive cyclosporin A monotherapy (given orally at a dose of 1.5-2.0mg/kg twice daily for 3 consecutive months, adjusted to maintain serum levels between 200-400 ng/ml and tapered by 50 mg/d per week if patients achieved a complete response). Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study. In order to report the efficacy and safety of the combination therapy compared to cyclosporin A monotherapy for the treatment of adults with steroid-resistant/relapsed ITP. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02203422
Study type Interventional
Source Shandong University
Contact
Status Withdrawn
Phase Phase 3
Start date July 2014
View Details
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