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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01467661
First received: October 31, 2011
Last updated: February 6, 2014
Last verified: February 2014
  Purpose

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 ]

Estimated Enrollment: 50
Study Start Date: November 2011
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: April 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

  Eligibility

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

Inclusion Criteria:

  • Subjects must have completed Study SPD422 308
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01467661

Locations
Japan
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
Shire
Investigators
Principal Investigator: Kanakura, Prof Osaka University Hospital
  More Information

No publications provided

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01467661     History of Changes
Other Study ID Numbers: SPD422-309
Study First Received: October 31, 2011
Last Updated: February 6, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

ClinicalTrials.gov processed this record on July 23, 2014