Long-term Safety of SPD422 in Japanese Adults With Essential Thrombocythaemia
This study is ongoing, but not recruiting participants.
Sponsor:
Shire Development LLC
Information provided by (Responsible Party):
Shire Development LLC
ClinicalTrials.gov Identifier:
NCT01467661
First received: October 31, 2011
Last updated: April 25, 2013
Last verified: April 2013
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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 Development LLC:
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
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 Development LLC
Investigators
| Principal Investigator: | Kanakura, Prof | Osaka University Hospital |
More Information
No publications provided
| Responsible Party: | Shire Development LLC |
| ClinicalTrials.gov Identifier: | NCT01467661 History of Changes |
| Other Study ID Numbers: | SPD422-309 |
| Study First Received: | October 31, 2011 |
| Last Updated: | April 25, 2013 |
| 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 June 18, 2013