drugset / Trial / NCT02868099

Efficacy and Safety of Romiplostim in Adult Subjects With Persistent or Chronic Immune Thrombocytopenia (ITP)

NCT02868099 ↗

Phase 3 Completed 203 enrolled Kyowa Kirin Co., Ltd.
RandomizedParallel-groupDouble-blindTreatment

Summary

The objective is to evaluate the efficacy and safety of romiplostim for injection in adlut subjects with persistent or chronic primary immune thrombocytopenia (ITP).

Timeline

Start
2015-09
Primary completion
2017-02
Completion
2017-06

Outcome

Met primary endpoint

paper were 2 (0-6) and 0 (0-2) in patients administered romiplostim and placebo, respectively (P < .001). PMID 37601010 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Romiplostim Peptide — Subcutaneous