NCT04588194 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Cooper N, Terrinoni I, Newland A
The efficacy and safety of romiplostim in adult patients with chronic immune thrombocytopenia. Ther Adv Hematol. 2012 Oct;3(5):291-8. doi: 10.1177/2040620712453596.
Gómez-Almaguer D, Herrera-Rojas MA, Jaime-Pérez JC, Gómez-De León A, Cantú-Rodríguez OG, Gutiérrez-Aguirre CH, Tarín-Arzaga L, Hernández-Reyes J, Ruiz-Arguelles GJ
Eltrombopag and high-dose dexamethasone as frontline treatment of newly diagnosed immune t
Gómez-Almaguer D, Tarín-Arzaga L, Moreno-Jaime B, Jaime-Pérez JC, Ceballos-López AA, Ruiz-Argüelles GJ, Ruiz-Delgado GJ, Cantú-Rodríguez OG, Gutiérrez-Aguirre CH, Sánchez-Cárdenas M
High response rate to low-dose rituximab plus high-dose dexamethasone as
Vishnu P, Aboulafia DM
Long-term safety and efficacy of romiplostim for treatment of immune thrombocytopenia. J Blood Med. 2016 May 25;7:99-106. doi: 10.2147/JBM.S80646. eCollection 2016. Review.

Romiplostim in Combination With Low-dose Rituximab and High-dose Dexamethasone as Frontline Treatment for Immune Thrombocytopenia

Clinical trial NCT04588194 - References