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

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ClinicalTrials.gov Identifier: NCT01214915
Recruitment Status : Completed
First Posted : October 5, 2010
Results First Posted : September 25, 2013
Last Update Posted : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Essential Thrombocythemia (ET) Drug: Anagrelide Hydrochloride Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : October 27, 2010
Actual Primary Completion Date : October 24, 2012
Actual Study Completion Date : October 24, 2012


Arm Intervention/treatment
Experimental: Anagrelide Hydrochloride Drug: Anagrelide Hydrochloride
Subjects will be started at 1.0 mg per day and titrated as necessary.
Other Name: SPD422




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01214915


Locations
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Japan
Akita University Hospital
Hiroomote Aza Hasunuma 44-2, Akita-shi, Japan, 05 010-8543
Juntendo University Hospital
Hongo 3-1-3, Bunkyo-ku, Japan, 13 113-8431
Tokyo Metropolitan Cancer and Infectious diseases Center Kom
Honkomagome 3-18-22, Bunkyo-ku, Japan, 13 113-8677
Nippon Medical School Hospital
Sendagi 1-1-5, Bunkyo-ku, Japan, 13 113-8603
Chiba University Hospital
Chuo-ku Inohana 1-8-1, Chiba-shi, Japan, 12 260-8677
Tokai University Hospital
Shimokasuya143, Isehara-shi, Japan, 259-1143
Juntendo University Shizuoka Hospital
Nagaoka 1129, Izunokuni-shi, Japan, 22 410-2295
Gunma University Hospital
Showa-machi 3-39-15, Maebashi-shi, Japan, 10 371-8511
NHO Tokyo Medical Center
Higashigaoka 2-5-1, Meguro-ku, Japan, 13 152-8902
University of Miyazaki Hospital
Kiyotake-cho Oaza Kihara 5200, Miyazaki-shi, Japan, 45 889-1692
NHO Nagoya Medical Center
Naka-ku Sannomaru 4-1-1, Nagoya-shi, Japan, 23 460-0001
Niigata Cancer Center Hospital
Chuo-ku Kawagishi-cho 2-15-3, Niigata-shi, Japan, 15 951-8566
Okayama University Hospital
Kita-ku Shikata-cho 2-5-1, Okayama-shi, Japan, 33 700-8558
Osaka City University Hospital
Abeno-ku Asahi-machi 1-5-7, Osaka-shi, Japan, 27 545-8586
Hokkaido University Hospital
Kita-ku Kita14jo Nishi5, Sapporo-shi, Japan, 01 060-8648
Keio University Hospital
Shinano-machi 35, Shinjyuku-ku, Japan, 13 160-8582
Osaka University Hospital
Yamadaoka 2-15, Suita-shi, Japan, 27 565-0871
Mie University Hospital
Edobashi 2-174, Tsu-shi, 24, Japan, 514-8507
Tokushima University Hospital
Kuramoto-cho 2-50-1, Tokushima-shi, Japan, 770-8503
Sponsors and Collaborators
Shire
Investigators
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Study Director: Study Director Shire

Publications of Results:
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Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01214915     History of Changes
Other Study ID Numbers: SPD422-308
First Posted: October 5, 2010    Key Record Dates
Results First Posted: September 25, 2013
Last Update Posted: December 13, 2018
Last Verified: November 2018
Additional relevant MeSH terms:
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Thrombocytosis
Thrombocythemia, Essential
Blood Platelet Disorders
Hematologic Diseases
Myeloproliferative Disorders
Bone Marrow Diseases
Blood Coagulation Disorders
Hemorrhagic Disorders
Anagrelide
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors