Safety and Efficacy Study of Romiplostim to Treat Immune Thrombocytopenia (ITP) in Pediatric Patients

Phase 3 Completed 62 enrolled Amgen

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy of romiplostim in the treatment of thrombocytopenia in pediatric patients with Immune thrombocytopenia purpura (ITP) as measured by durable platelet response.

Timeline

Start: 2012-01
Primary completion: 2015-02
Completion: 2015-02

Outcome

Met primary endpoint

paper Durable platelet response was seen in 22 (52%) patients in the romiplostim group and two (10%) in the placebo group PMID 27103127 ↗

paper group (p=0·002, odds ratio 9·1 [95% CI 1·9-43·2]). PMID 27103127 ↗

Publications

Tarantino MD, Bussel JB, Blanchette VS, Despotovic J, Bennett C, Raj A, Williams B, Beam D, Morales J, Rose MJ, Carpenter N, Nie K, Eisen M. Romiplostim in children with immune thrombocytopenia: a phase 3, randomised, double-blind, placebo-controlled study. Lancet. 2016 Jul 2;388(10039):45-54. doi: 10.1016/S0140-6736(16)00279-8. Epub 2016 Apr 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Romiplostim	Peptide	10 ug/kg	Subcutaneous