A Phase 3, Randomized, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Romiplostim Plus Predniso(lo)ne vs. Predniso(lo)ne Alone for the Treatment of Adults With Previously Untreated Primary Immune Thrombocytopenia (ITP)

Registry ID

2026-525454-11-00

Source registry

CTIS

Status

Authorised

Phase

PHASE3

Study type

INTERVENTIONAL

Sponsor

Amgen Inc.

Enrollment

20

Last update

2026-08-14

Conditions

• Diagnosis of primary ITP according to the 2019 International Consensus Report that is previously untreated and requires treatment
• Diseases [C] - Hemic and Lymphatic Diseases [C15]

Primary outcomes

Durable Platelet Response (DPR), defined as achieving at least 9999 platelet responses of ≥ 50 × 109/L during the 9999, with at least 1 platelet response of ≥ 50 × 109/L 9999. Qualifying platelet counts must be measured at least 5 days apart.

Locations

• , , Spain

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