Effect of SPD422 on Platelet Lowering and Safety in Japanese Adults With At Risk Essential Thrombocythaemia

Phase 3

Completed

Brief Summary: The purpose of this study is to investigate how effective and safe SPD422 (Anagrelide Hydrochloride) is in Japanese subjects, diagnosed with Essential Thrombocythemia, who's previously treatment has either not been effective or has caused unacceptable adverse reactions. The study will aim to show that platelet counts can be safely reduced in treated patients to below 600 x 10\^9/L after a minimum of three months treatment. To demonstrate an positive effect platelet levels will need to remain below 600 x 10\^9/L for at least 4 weeks.

Recruitment & Eligibility

Inclusion Criteria

Subjects must have previously been treated with a cytoreductive therapy and been intolerant or refractory to that therapy.

Exclusion Criteria

Subjects should not have any other underlying conditions or medications that would confound the study analysis or interact with the study medication.

Arm && Interventions

Group	Intervention	Description
Anagrelide Hydrochloride	Anagrelide Hydrochloride	-

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects Who Responded in Platelet Count	12 months	A response was defined as platelet counts to \<600x10\^9/L across consecutive visits for at least 4 weeks following at least 3 months of treatment.

Secondary Outcome Measures

Name	Time	Method
Percentage of Subjects Who Responded in Platelet Count Whose Baseline Platelet Count Was ≥600x10^9/L	12 months	A response was defined as platelet counts to \<600x10\^9/L across consecutive visits for at least 4 weeks following at least 3 months of treatment.
Percentage of Subjects With at Least 50% Reduction in Platelet Count	12 months	Subjects who achieved at least 50% reduction in platelet count from their baseline level across consecutive visits for at least 4 weeks and following 3 months of treatment.
Percentage of Subjects With Normalization in Platelet Count	12 months	Normalization was defined as platelet counts ≤400x10\^9/L across consecutive visits for at least 4 weeks following at least 3 months of treatment.
Percentage of Subjects Who Responded in Platelet Count Whose Baseline Platelet Count Was <600x10^9/L	12 months	A response was defined as platelet counts to \<600x10\^9/L across consecutive visits for at least 4 weeks following at least 3 months of treatment.

Locations (19): Juntendo University Shizuoka Hospital
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Nagaoka 1129, Izunokuni-shi, Japan
Tokai University Hospital
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Isehara-shi, Kanagawa Prefecture, Japan
Nippon Medical School Hospital
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Sendagi 1-1-5, Bunkyo-ku, Japan
Akita University Hospital
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Akita-shi, Akita Prefecture, Japan
Tokushima University Hospital
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Tokushima-shi, Tokushima Perfecture, Japan
Juntendo University Hospital
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Hongo 3-1-3, Bunkyo-ku, Japan
Tokyo Metropolitan Cancer and Infectious diseases Center Kom
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Honkomagome 3-18-22, Bunkyo-ku, Japan
Chiba University Hospital
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Chuo-ku Inohana 1-8-1, Chiba-shi, Japan
NHO Nagoya Medical Center
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Nagoya-shi, Chubu, Japan
Osaka City University Hospital
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Osaka-shi, Kansai, Japan
Gunma University Hospital
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Showa-machi 3-39-15, Maebashi-shi, Japan
NHO Tokyo Medical Center
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Higashigaoka 2-5-1, Meguro-ku, Japan
Hokkaido University Hospital
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Sapporo-shi, Hokkaidō Prefecture, Japan
Mie University Hospital
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Tsu-shi, 24, Mie, Japan
Niigata Cancer Center Hospital
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Chuo-ku Kawagishi-cho 2-15-3, Niigata-shi, Japan
Okayama University Hospital
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Okayama-shi, Okayama Prefecture, Japan
University of Miyazaki Hospital
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Miyazaki-shi, Miyazaki Prefecture, Japan
Osaka University Hospital
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Suita-shi, Osaka Prefecture, Japan
Keio University Hospital
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Tokyo, Japan