Pharmacokinetics, Safety, and Pharmacodynamics of Romiplostim in Chinese Subjects With Immune Thrombocytopenia: A Phase I/II Trial.

ABSTRACT: Romiplostim is approved for the treatment of immune thrombocytopenia (ITP). This study aimed to evaluate the pharmacokinetics, safety, and pharmacodynamics of romiplostim in Chinese patients with ITP. This multicenter, open-label, dose-escalation phase I/II trial enrolled ITP patients from 5 centers in China between October 2015 and August 2017. There were 2 cohorts: 1 μg/kg and 3 μg/kg weekly for 2 weeks. The end points included pharmacokinetics, platelet changes from baseline, hematological indicators, and adverse events (AEs). Sixteen participants, with 8 patients in each cohort, were enrolled. In the 1 μg/kg cohort, time to maximum concentration was 4.00 (4.00-7.83) hours, maximum serum drug concentration was 52.0 (16.0-228.0) pg/mL, and area under the serum drug concentration-time cur

SUBMITTER: Qi J 

PROVIDER: S-EPMC9299913 | biostudies-literature | 2022 Mar

REPOSITORIES: biostudies-literature