Romiplostim in primary immune thrombocytopenia that is persistent or chronic: phase III multicenter, randomized, placebo-controlled clinical trial in China.

ABSTRACT:

Background

Multiple trials have confirmed that romiplostim could increase platelet count in individuals with primary immune thrombocytopenia (ITP), but no related study has assessed Chinese patients.

Objectives

To assess the effectiveness of romiplostim as a second-line treatment of persistent or chronic ITP in Chinese adults.

Methods

This phase III multicenter, randomized, placebo-controlled, double-blind, then open-label clinical trial (NCT02868099, CTR20150395) was conducted at 28 investigational sites in China. The patients were randomly assigned (3:1) to romiplostim (starting and maximum doses of 1 and 10 μg/kg, respectively) or placebo for 9 weeks (double-blind period), followed by the open-label period (both groups administered romiplostim) to week 22. The prim

SUBMITTER: Zhou H 

PROVIDER: S-EPMC10439391 | biostudies-literature | 2023 Jul

REPOSITORIES: biostudies-literature