Romiplostim Plus Dexamethasone vs Dexamethasone in Patients With Newly Diagnosed Primary Immune Thrombocytopenia

• Status: Not yet recruiting
• Trial end date: 2024-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Phase III, open-labeled, randomized and multicenter clinical trial to evaluate the superiority of romiplostim plus dexamethasone vs dexamethasone alone in patients with newly diagnosed primary immune thrombocytopenia

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Treatments: BB 1101; Dexamethasone; Dexamethasone acetate

Criteria

Main inclusion criteria:

1. Age ≥ 18 years of age at the time of signing informed consent.

2. Newly diagnosis of primary ITP according to the International Working Group assessment [1] and previously untreated for ITP.

3. Platelet counts <30x109/L or ITP with platelet counts <50x109/L and concomitant bleeding symptoms.

4. Serum creatinine concentration ≤1.5 mg/dL.

Main exclusion criteria:

1. WHO (World Health Organization) performance status >2.

2. Previous therapy with rituximab, corticosteroids, immunomodulating agents, hematopoietic analogs and fostamatinib for any other reason despite ITP.

3. Previous use of romiplostim, PEG-recombinant human (rHu) megakaryocyte growth and development factor, eltrombopag, recombinant human anti-thrombopoietin (rHuTPO), or any platelet-producing agent