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

October 31, 2011
February 6, 2014
November 2011
April 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01467661 on ClinicalTrials.gov Archive Site
Platelet count [ Time Frame: 3, 6, 9 and 12 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Long-term Safety of SPD422 in Japanese Adults With Essential Thrombocythaemia
A Phase 3, Multi-centre, Open-label, Extension Study to Investigate the Long-term Safety of SPD422 in Japanese Adults With Essential Thrombocythaemia

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.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Essential Thrombocythaemia
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
Experimental: SPD422 (anagrelide hydrochloride)
Intervention: Drug: SPD422 (anagrelide hydrochloride)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
May 2015
April 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects must have completed Study SPD422 308
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01467661
SPD422-309
No
Shire
Shire
Not Provided
Principal Investigator: Kanakura, Prof Osaka University Hospital
Shire
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP