NCT05323617

Efficacy of Romiplostim in Treatment of SAA in Adults Previously Untreated With or Refractory to Immunosuppressive Therapy

Two Arm Bridging Study to Evaluate the Efficacy of Romiplostim in the Treatment of Adult Severe Aplastic Anemia Participants Who Are Either Previously Untreated With IST or Refractory to IST

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Romiplostim has been used in clinical trials for the treatment of severe and very severe aplastic anemia (SAA/vSAA) 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 participants with SAA/vSAA. The primary objectives of this study are to: Arm 1: Evaluate the efficacy of romiplostim and IST in adult SAA/vSAA participants who are previously untreated with IST (1L) Arm 2: Evaluate the efficacy of romiplostim treatment in adult SAA/vSAA participants who are refractory to IST (2L+)

Conditions

• Severe Aplastic Anemia (SAA)

Interventions

Type	Name	Description
DRUG	Romiplostim	Administered as a subcutaneous injection.
DRUG	Antithymocyte Globulin	Horse or rabbit antithymocyte globulin administered as an intravenous infusion.
DRUG	Cyclosporine A	Administered orally.

Timeline

• Start date: 2023-08-31
• Primary completion: 2025-02-25
• Completion: 2025-02-25
• First posted: 2022-04-12
• Last updated: 2023-09-29

Regulatory

• FDA-regulated drug study