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

Shire53 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Essential Thrombocythemia (ET)

Interventions

Anagrelide HydrochlorideDRUG

Subjects will be started at 1.0 mg per day and titrated as necessary.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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.

Locations (19)

Akita University Hospital

Akita, Akita, Japan

Juntendo University Hospital

Hongo 3-1-3, Bunkyo-ku, Japan

Outcomes

Primary Outcomes

Percentage of Subjects Who Responded in Platelet Count

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.

Time frame: 12 months

Secondary Outcomes

Percentage of Subjects With at Least 50% Reduction in Platelet Count

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.

Time frame: 12 months

Percentage of Subjects With Normalization in Platelet Count

Normalization was defined as platelet counts ≤400x10\^9/L across consecutive visits for at least 4 weeks following at least 3 months of treatment.

Time frame: 12 months

Percentage of Subjects Who Responded in Platelet Count Whose Baseline Platelet Count Was ≥600x10^9/L

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.

Time frame: 12 months

Percentage of Subjects Who Responded in Platelet Count Whose Baseline Platelet Count Was <600x10^9/L

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.

Time frame: 12 months

Data from ClinicalTrials.gov

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