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

Shire

Status and phase: Completed; Phase 3

Conditions: Essential Thrombocythemia (ET)

Treatments: Drug: Anagrelide Hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT01214915

SPD422-308

Details and patient eligibility

About

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.

Enrollment: 53 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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53 participants in 1 patient group

Anagrelide Hydrochloride

Experimental group

Treatment:

Drug: Anagrelide Hydrochloride