Evaluate the efficacy, safety, and PK of avatrombopag given for 26 weeks in Japanese adults with chronic immune thrombocytopenia (ITP).
This Phase 3, multicenter, open label study will evaluate the efficacy, safety, and population pharmacokinetics (PK) of avatrombopag in Japanese adults with chronic ITP. At least 19 subjects will be enrolled. The study will consist of 3 phases: Pre-enrollment, Primary Investigation, and Extension Phase until market authorization in Japan.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
Avatrombopag 20 mg given once daily (initial dose). Dosage adjustments were determined by the physician to maintain a platelet count between 50 x 10\^9 to 200 x 10\^9 as defined in the protocol and in accordance with overseas labeling.
Sobi Site 105
Toyohashi, Aichi-ken, Japan
Sobi Site 110
Tōon, Ehime, Japan
Sobi Site 118
Cumulative Number of Weeks of Platelet Response
Cumulative number of weeks in which the platelet count is ≥50×10\^9/L during 26 weeks of treatment in the absence of rescue therapy.
Time frame: 26 weeks of active treatment
Response Rate at Day 8
Proportion of subjects with a platelet response ≥50×10\^9/L at Day 8 in the absence of rescue therapy
Time frame: Day 8
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Iizuka-shi, Fukuoka, Japan
Sobi Site 116
Kitakyushu, Fukuoka, Japan
Sobi Site 117
Kurume, Fukuoka, Japan
Sobi Site 114
Gifu, Gifu, Japan
Sobi Site 115
Fukuyama-shi, Hiroshima, Japan
Sobi Site 109
Hiroshima, Hiroshima, Japan
Sobi Site 108
Kobe, Hyōgo, Japan
Sobi Site 113
Kanazawa, Ishikawa-ken, Japan
...and 9 more locations