Chronic Immune Thrombocytopenia
Conditions
Interventions
Subjects will receive a starting dose of 20 mg avatrombopag once daily and will be allowed to change their dose and dosing frequency (maximum dose 40 mg daily, minimum dose 20 mg once weekly) in accor
Sponsors
Shimizu Yasuko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Men and women >_18 years of age. -Subject has a confirmed diagnosis of chronic ITP (>_12 months duration) and has had an insufficient response to a previous ITP treatment, in the opinion of the Investigator. -Subject has an average of 2 platelet counts 35x10^9/L). The 2 samples must be obtained >_48 hours and <_2 weeks apart.
Exclusion criteria
Exclusion criteria: '-Subjects with known secondary immune thrombocytopenia (e.g., with known Helicobacter pylori-induced ITP, subjects infected with known human immunodeficiency virus [HIV] or hepatitis C virus [HCV] or subjects with known systemic lupus erythematosus). -Subjects with known inherited thrombocytopenia (e.g., MYH-9 disorders) or hereditary thrombophilic disorders (e.g., Factor V Leiden, antithrombin III deficiency).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The cumulative number of weeks in which the platelet count is >_50x10^9/L during 26 weeks of treatment in the absence of rescue therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Platelet response rate at Day 8 (as defined by the proportion of subjects with a platelet response >_50x10^9/L at Day 8). | — |
Contacts
Public ContactYasuko Shimizu
CMIC Co., Ltd.
Outcome results
None listed