Efficacy of Romiplostim in Treatment of Severe Aplastic Anemia in Non-Asian Adults Previously Untreated With or Refractory to Immunosuppressive Therapy

• Status: Not yet recruiting
• Trial end date: 2024-01-26

Summary

Romiplostim has been used in clinical trials for the treatment of severe aplastic anemia (SAA) in Asian participants who are either previously untreated with immunosuppressive therapy (IST) or refractory to IST. This study will evaluate the efficacy of romiplostim in the treatment of non-Asian participants with SAA.

The primary objectives of this study are to:

Arm 1: evaluate the efficacy of romiplostim and immunosuppressive therapy (IST) in adult non-Asian severe aplastic anemia (SAA) participants who are previously untreated with IST (1L)

Arm 2: evaluate the efficacy of romiplostim treatment in adult non-Asian SAA participants who are refractory to IST (2L+)

• Phase: Phase 2

Details

• Lead Sponsor: Amgen
• Treatments: Antilymphocyte Serum; Cyclosporine; Cyclosporins