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

Phase 3

Completed

• Conditions: Essential Thrombocythemia (ET)
• Interventions: Drug: Anagrelide Hydrochloride

• Registration Number: NCT01214915
• Lead Sponsor: Shire

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-04
• Study First Submitted QC: 2010-10-04
• Study First Posted: 2010-10-05
• Study Start: 2010-10-27
• Primary Completion: 2012-10-24
• Study Completion: 2012-10-24
• Results First Submitted: 2013-07-24
• Results First Submitted QC: 2013-07-24
• Results First Posted: 2013-09-25
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-24
• Last Update Posted: 2021-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

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 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.
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.

Trial Locations

Locations (19)

Akita University Hospital; 🇯🇵 Akita-shi, Akita Prefecture, Japan

Juntendo University Hospital; 🇯🇵 Hongo 3-1-3, Bunkyo-ku, Japan

Tokyo Metropolitan Cancer and Infectious diseases Center Kom; 🇯🇵 Honkomagome 3-18-22, Bunkyo-ku, Japan

Nippon Medical School Hospital; 🇯🇵 Sendagi 1-1-5, Bunkyo-ku, Japan

Chiba University Hospital; 🇯🇵 Chuo-ku Inohana 1-8-1, Chiba-shi, Japan

NHO Nagoya Medical Center; 🇯🇵 Nagoya-shi, Chubu, Japan

Hokkaido University Hospital; 🇯🇵 Sapporo-shi, Hokkaidō Prefecture, Japan

Juntendo University Shizuoka Hospital; 🇯🇵 Nagaoka 1129, Izunokuni-shi, Japan

Tokai University Hospital; 🇯🇵 Isehara-shi, Kanagawa Prefecture, Japan

Osaka City University Hospital; 🇯🇵 Osaka-shi, Kansai, Japan

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