Avatrombopag for adult chronic primary immune thrombocytopenia: a randomized phase 3 trial in China.

ABSTRACT:

Background

Immune thrombocytopenia (ITP) is an autoimmune disorder with decreased platelet counts and increased bleeding risk.

Objectives

To evaluate the efficacy and safety of avatrombopag, a second-generation oral thrombopoietin receptor agonist, for the treatment of Chinese patients with chronic primary ITP.

Methods

This multicenter, randomized, double-blind, placebo-controlled phase 3 study (CTR20210431) consisted of a 6-week double-blind core treatment phase followed by a 20-week, open-label extension phase. Chinese adults with chronic primary ITP for at least 12 months and a platelet count <30 × 10⁹/L were randomized (2:1) to receive avatrombopag (initial dose of 20 mg/day) or matched placebo. The primary endpoint was the proportion of subjects with a

SUBMITTER: Mei H 

PROVIDER: S-EPMC10493258 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature