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Completed

NCT Number: NCT01214915

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

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.

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Key information

Conditions

Essential Thrombocythemia (ET) Blood Coagulation Disorders Blood Platelet Disorders Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Myeloproliferative Disorders Thrombocythemia, Essential Thrombocytosis

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Akita University Hospital, Akita, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Anagrelide hydrochloride

Drug

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

Other names: SPD422

Primary outcomes

  1. Percentage of Subjects Who Responded in Platelet Count

    Time frame: 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 outcomes

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

    Time frame: 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.

  2. Percentage of Subjects With Normalization in Platelet Count

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Shire

Industry

Registry information

Official study title

A Phase 3, Open-label, Single-arm Study Evaluating the Effect of SPD422 on Platelet Lowering and Safety in Japanese Adults With At Risk Essential Thrombocythaemia Who Are Intolerant or Refractory to Current Cytoreductive Treatment

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Oct 5, 2010
Registry last updated
Jun 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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