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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01467661
First received: October 31, 2011
Last updated: June 22, 2016
Last verified: June 2016

October 31, 2011
June 22, 2016
November 2011
May 2015   (final data collection date for primary outcome measure)
  • Change From Baseline in Platelet Count at Final Assessment [ Time Frame: Baseline and final assessment (within 5 days of the last dose of investigational product) ] [ Designated as safety issue: No ]
    Baseline considered from study SPD422-308 (NCT01214915). Final assessment was defined as the last non-missing data (End of study visit in SPD422-309 [NCT01467661], or early termination visit either in SPD422-308 [NCT01214915] or SPD422-309 [NCT01467661], or last available study visit).
  • Change From Baseline in Platelet Count During Post-marketing Trial at Final Assessment [ Time Frame: Baseline and final assessment (within 5 days of the last dose of investigational product) ] [ Designated as safety issue: No ]
    Baseline considered from study SPD422-308 (NCT01214915). Final assessment was defined as the last non-missing data (End of study visit in SPD422-309 [NCT01467661], or early termination visit either in SPD422-308 [NCT01214915] or SPD422-309 [NCT01467661], or last available study visit).
  • Percentage of Participants Who Achieved Platelet Count Less Than (<) 600 [ Time Frame: Baseline, Week 1, Month 1-12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, and final assessment (within 5 days of the last dose of investigational product) ] [ Designated as safety issue: No ]
    Baseline considered from study SPD422-308 (NCT01214915). Final assessment was defined as the last non-missing data (End of study visit in SPD422-309 [NCT01467661], or early termination visit either in SPD422-308 [NCT01214915] or SPD422-309 [NCT01467661], or last available study visit). Participants who achieved platelet count <600 x 10^9 platelets per liter at each visit were reported.
  • Percentage of Participants Who Achieved Platelet Count Less Than (<) 600 During Post-marketing Trial [ Time Frame: Baseline and final assessment (within 5 days of the last dose of investigational product) ] [ Designated as safety issue: No ]
    Baseline considered from study SPD422-308 (NCT01214915). Final assessment was defined as the last non-missing data (End of study visit in SPD422-309 [NCT01467661], or early termination visit either in SPD422-308 [NCT01214915] or SPD422-309 [NCT01467661], or last available study visit). Participants who achieved platelet count <600 x 10^9 platelets per liter during the post-marketing trial were reported.
  • Percentage of Participants Who Achieved Shift From Baseline in Platelet Count [ Time Frame: Baseline and final assessment (within 5 days of the last dose of investigational product) ] [ Designated as safety issue: No ]
    Baseline considered from study SPD422-308 (NCT01214915). Final assessment (FA) was defined as the last non-missing data (End of study visit in SPD422-309 [NCT01467661], or early termination visit either in SPD422-308 [NCT01214915] or SPD422-309 [NCT01467661], or last available study visit). Participants who had platelet count <600 x 10^9 platelet per liter and greater than equal (>=) 600 x 10^9 platelet per liter at the final assessment as a shift from baseline was reported. Percentage of participants with shift = number of participants with shift / Safety analysis set (53 participants) * 100.
  • Percentage of Participants Who Achieved Shift From Baseline in Platelet Count During Post-marketing Trial [ Time Frame: Baseline and final assessment (within 5 days of the last dose of investigational product) ] [ Designated as safety issue: No ]
    Baseline considered from study SPD422-308 (NCT01214915). Final assessment (FA) was defined as the last non-missing data (End of study visit in SPD422-309 [NCT01467661], or early termination visit either in SPD422-308 [NCT01214915] or SPD422-309 [NCT01467661], or last available study visit). Participants who had platelet count <600 x 10^9 platelet per liter and greater than equal (>=) 600 x 10^9 platelet per liter at the final assessment as a shift from baseline during the post marketing trial was reported. Percentage of participants with shift = number of participants with shift / post-marketing safety analysis set (33 participants) * 100.
  • Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) [ Time Frame: From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product ] [ Designated as safety issue: Yes ]
    An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken.
  • Percentage of Participants With TEAEs and TESAEs During Post-marketing Trial [ Time Frame: From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product ] [ Designated as safety issue: Yes ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken.
  • Percentage of Participants With TEAEs and TESAEs Related to Clinical Laboratory Result [ Time Frame: From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product ] [ Designated as safety issue: Yes ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken. Clinical Laboratory analysis included hematology, biochemistry, and urinalysis.
  • Percentage of Participants With TEAEs and TESAEs Related to Clinical Laboratory Result During Post-marketing Trial [ Time Frame: From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product ] [ Designated as safety issue: Yes ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken. Clinical Laboratory analysis included hematology, biochemistry, and urinalysis.
  • Percentage of Participants With TEAEs and TESAEs Related to Vital Signs [ Time Frame: From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product ] [ Designated as safety issue: Yes ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken. Vital signs included pulse rate, systolic and diastolic blood pressure, and weight.
  • Percentage of Participants With TEAEs and TESAEs Related to Vital Signs During Post-marketing Trial [ Time Frame: From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product ] [ Designated as safety issue: Yes ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken. Vital signs included pulse rate, systolic and diastolic blood pressure, and weight.
  • Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities [ Time Frame: From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product ] [ Designated as safety issue: Yes ]
    Standard 12-Lead ECG analysis was performed to identify the ECG abnormalities. Clinically significant abnormalities like QT prolongation, atrial fibrillation, were decided by the investigator during the study.
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.
Complete list of historical versions of study NCT01467661 on ClinicalTrials.gov Archive Site
Not Provided
Platelet count [ Time Frame: 3, 6, 9 and 12 months ] [ Designated as safety issue: Yes ]
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 Thrombocythemia (ET)
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 Names:
  • 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.
 
Completed
41
May 2015
May 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects must have completed Study SPD422 308
Both
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01467661
SPD422-309
No
Not Provided
Not Provided
Shire
Shire
Not Provided
Principal Investigator: Kanakura, Prof Osaka University Hospital
Shire
June 2016

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