This Phase 3 study is designed to evaluate the efficacy and safety of romiplostim in combination with predniso(lo)ne compared with predniso(lo)ne alone in adults with previously untreated Primary Immune Thrombocytopenia (ITP).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
126
Administered subcutaneously.
Administered orally.
MemorialCare Long Beach Medical Center
Long Beach, California, United States
RECRUITINGThe Bleeding and Clotting Disorders Institute
Peoria, Illinois, United States
RECRUITINGHematology Oncology Associates of Fredericksburg
Fredericksburg, Virginia, United States
RECRUITINGPercentage of Participants With a Durable Platelet Response (DPR)
Time frame: 8 weeks
Time to Next Treatment (TTNT)
Time frame: 12 months
Cumulative Exposure to Corticosteroids
Time frame: 12 months
Change From Baseline in ITP Patient Assessment Questionnaire (ITP-PAQ)
Time frame: 12 months
Change in Summary Scores and Visual Analogue Scale (VAS) Scores per EuroQol 5-Dimension 5-Level (EQ 5D-5L)
Time frame: 12 months
Incidence of Hospitalization and Rescue Medication in Part 1
Time frame: 6 months
Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), Treatment-Emergent Adverse Events of Interest (EOI), and Fatal TEAEs
Time frame: 12 months
Percentage of Participants With Clinically Significant Bleeding Events in the Immune Thrombocytopenia-specific Bleeding Assessment Tool (ITP-BAT)
Time frame: 6 months
Serum Trough Concentration (Ctrough) of Romiplostim
Time frame: 6 months
Number of Participants With Anti-Romiplostim Antibodies and Anti-Thrombopoietin (TPO) Antibodies
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.