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COMPLETED
NCT05369208
PHASE3

Evaluation of Avatrombopag for the Treatment of Thrombocytopenia in Japanese Adults With Chronic ITP

Sponsor: Sobi, Inc.

View on ClinicalTrials.gov

Summary

Evaluate the efficacy, safety, and PK of avatrombopag given for 26 weeks in Japanese adults with chronic immune thrombocytopenia (ITP).

Official title: An Open-label Study to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Thrombocytopenia in Japanese Adults With Chronic Immune Thrombocytopenia

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

19

Start Date

2022-06-15

Completion Date

2025-10-29

Last Updated

2026-06-03

Healthy Volunteers

No

Interventions

DRUG

Avatrombopag Oral Tablet

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.

Locations (19)

Sobi Site 105

Toyohashi, Aichi-ken, Japan

Sobi Site 110

Tōon, Ehime, Japan

Sobi Site 118

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

Sobi Site 101

Shiwa-gun, Iwata, Japan

Sobi Site 111

Fujisawa, Kanagawa, Japan

Sobi Site 119

Kumamoto, Kumamoto, Japan

Sobi Site 107

Hirakata, Osaka, Japan

Sobi Site 106

Suita, Osaka, Japan

Sobi Site 104

Hachiōji-shi, Tokyo, Japan

Sobi Site 103

Bunkyō City, Toyko, Japan

Sobi Site 102

Chuo-shi, Yamanashi, Japan

Sobi Site 112

Kofu, Yamanashi, Japan