Long-term Safety of SPD422 in Japanese Adults With Essential Thrombocythaemia

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: October 31, 2011
Last updated: May 15, 2015
Last verified: May 2015
The purpose of this study is to provide SPD422 to subjects who completed Study SPD422 308 and, in the opinion of the Investigator, will continue to benefit from treatment.

Condition Intervention Phase
Essential Thrombocythaemia
Drug: SPD422 (anagrelide hydrochloride)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 3, Multi-centre, Open-label, Extension Study to Investigate the Long-term Safety of SPD422 in Japanese Adults With Essential Thrombocythaemia

Resource links provided by NLM:

Further study details as provided by Shire:

Primary Outcome Measures:
  • Safety of long-term use of SPD422 [ Time Frame: 3, 6, 9 and 12 months ] [ Designated as safety issue: Yes ]
    Safety will be determined by the changes from study baseline in clinical laboratory evaluations, vital signs, and electrocardiograms (ECGs) recorded as an AE if clinically relevant.

Secondary Outcome Measures:
  • Platelet count [ Time Frame: 3, 6, 9 and 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 41
Study Start Date: November 2011
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SPD422 (anagrelide hydrochloride) Drug: SPD422 (anagrelide hydrochloride)
Subjects will be continued on the dose of anagrelide that controlled their platelet levels in Study 308 and titrated if necessary.
Other Name: Xagrid, Agrylin


Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects must have completed Study SPD422 308
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01467661

Akita University Hospital
Akita-shi, Akita, Japan, 010-8543
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
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
Miyazaki-shi, Miyazaki, Japan, 889-1692
Niigata Cancer Centre
Niigata-shi, Niigata, Japan, 951-8566
Okayama University Hospital
Kita-ku Shikata-cho 2-5-1, Okayama-shi, Japan, 33 700-8558
Osaka City University Hospital
Osaka-shi, Osaka, Japan, 545-0051
Osaka University Hospital
Suita-shi, Osaka, Japan, 565-0871
Hokkaido University Hospital
Kita-ku Kita14jo Nishi5, Sapporo-shi, Japan, 01 060-8648
Keio University Hospital
Shinjyuku-ku, Tokyo, Japan, 160-8582
Mie University Hospital
Edobashi 2-174, Tsu-shi, 24, Japan, 514-8507
Juntendo University Shizuoka Hospital
Nagaoka 1129, Izunokuni-shi, Japan, 22 410-2295
Sponsors and Collaborators
Principal Investigator: Kanakura, Prof Osaka University Hospital
  More Information

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01467661     History of Changes
Other Study ID Numbers: SPD422-309 
Study First Received: October 31, 2011
Last Updated: May 15, 2015
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Thrombocythemia, Essential
Blood Coagulation Disorders
Blood Platelet Disorders
Bone Marrow Diseases
Hematologic Diseases
Hemorrhagic Disorders
Myeloproliferative Disorders
Fibrin Modulating Agents
Fibrinolytic Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on May 24, 2016