drugset / Trial / NCT02389621
Safety and Efficacy Study of Lusutrombopag for Thrombocytopenia in Patients With Chronic Liver Disease Undergoing Elective Invasive Procedures
RandomizedParallel-groupTriple-blindTreatment
Summary
The primary purpose of this study is to compare the efficacy of lusutrombopag with placebo for the treatment of thrombocytopenia in patients with chronic liver disease who are undergoing elective invasive procedures.
Timeline
- Start
- 2015-06-15
- Primary completion
- 2017-04-05
- Completion
- 2017-04-19
Publications
- Flamm SL, Peck-Radosavljevic M, Fukuhara T, Bentley R, Katsube T, Ochiai T, Kano T, Tsukimura E, Sasaki R, Osaki Y. Pharmacokinetic Assessment and Treatment Effect of Lusutrombopag in Child-Pugh Class C Patients: Review of Patient Data from Two Clinical Studies and Post-Marketing Surveillance. Adv Ther. 2022 Sep;39(9):4285-4298. doi: 10.1007/s12325-022-02237-8. Epub 2022 Jul 29.
- Alkhouri N, Imawari M, Izumi N, Osaki Y, Ochiai T, Kano T, Bentley R, Trevisani F. Lusutrombopag Is Safe and Efficacious for Treatment of Thrombocytopenia in Patients With and Without Hepatocellular Carcinoma. Clin Gastroenterol Hepatol. 2020 Oct;18(11):2600-2608.e1. doi: 10.1016/j.cgh.2020.03.032. Epub 2020 Mar 20.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lusutrombopag | Small molecule | 3 mg | Oral |