Back to resultsLong-term Safety of SPD422 in Japanese Adults With Essential Thrombocythaemia
Primary Purpose
Essential Thrombocythemia (ET)
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
SPD422 (anagrelide hydrochloride)
Sponsored by
About this trial
This is an interventional treatment trial for Essential Thrombocythemia (ET)
Eligibility Criteria
Inclusion Criteria:
- Subjects must have completed Study SPD422 308
Sites / Locations
- Akita University Hospital
- Tokyo Metropolitan Cancer and Infectious diseases Center Kom
- Nippon Medical School Hospital
- Chiba University Hospital
- Hokkaido University Hospital
- Tokai University Hospital
- Gunma University Hospital
- NHO Tokyo Medical Center
- Mie University Hospital
- University of Miyazaki Hospital
- Niigata Cancer Centre
- Okayama University Hospital
- Osaka City University Hospital
- Osaka University Hospital
- Juntendo University Shizuoka Hospital
- Keio University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SPD422 (anagrelide hydrochloride)
Arm Description
Outcomes
Primary Outcome Measures
Change From Baseline in Platelet Count at Final Assessment
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
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
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
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
Baseline considered from study SPD422-308 (NCT01214915). Final assessment (FA) was defined as the last nonmissing 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
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)
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
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
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
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
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
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
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01467661
Brief Title
Long-term Safety of SPD422 in Japanese Adults With Essential Thrombocythaemia
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
October 27, 2010 (Actual)
Primary Completion Date
May 1, 2015 (Actual)
Study Completion Date
May 1, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shire
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Thrombocythemia (ET)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SPD422 (anagrelide hydrochloride)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SPD422 (anagrelide hydrochloride)
Other Intervention Name(s)
Xagrid, Agrylin
Intervention Description
Subjects will be continued on the dose of anagrelide that controlled their platelet levels in Study 308 and titrated if necessary.
Primary Outcome Measure Information:
Title
Change From Baseline in Platelet Count at Final Assessment
Description
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).
Time Frame
Baseline and final assessment (within 5 days of the last dose of investigational product)
Title
Change From Baseline in Platelet Count During Post-marketing Trial at Final Assessment
Description
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).
Time Frame
Baseline and final assessment (within 5 days of the last dose of investigational product)
Title
Percentage of Participants Who Achieved Platelet Count Less Than (<) 600
Description
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.
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)
Title
Percentage of Participants Who Achieved Platelet Count Less Than (<) 600 During Post-marketing Trial
Description
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.
Time Frame
Baseline and final assessment (within 5 days of the last dose of investigational product)
Title
Percentage of Participants Who Achieved Shift From Baseline in Platelet Count
Description
Baseline considered from study SPD422-308 (NCT01214915). Final assessment (FA) was defined as the last nonmissing 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.
Time Frame
Baseline and final assessment (within 5 days of the last dose of investigational product)
Title
Percentage of Participants Who Achieved Shift From Baseline in Platelet Count During Post-marketing Trial
Description
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.
Time Frame
Baseline and final assessment (within 5 days of the last dose of investigational product)
Title
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Description
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.
Time Frame
From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product
Title
Percentage of Participants With TEAEs and TESAEs During Post-marketing Trial
Description
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.
Time Frame
From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product
Title
Percentage of Participants With TEAEs and TESAEs Related to Clinical Laboratory Result
Description
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.
Time Frame
From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product
Title
Percentage of Participants With TEAEs and TESAEs Related to Clinical Laboratory Result During Post-marketing Trial
Description
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.
Time Frame
From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product
Title
Percentage of Participants With TEAEs and TESAEs Related to Vital Signs
Description
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.
Time Frame
From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product
Title
Percentage of Participants With TEAEs and TESAEs Related to Vital Signs During Post-marketing Trial
Description
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.
Time Frame
From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product
Title
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
Description
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.
Time Frame
From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects must have completed Study SPD422 308
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Akita University Hospital
City
Akita-shi
State/Province
Akita
ZIP/Postal Code
010-8543
Country
Japan
Facility Name
Tokyo Metropolitan Cancer and Infectious diseases Center Kom
City
Honkomagome 3-18-22
State/Province
Bunkyo-ku
ZIP/Postal Code
13 113-8677
Country
Japan
Facility Name
Nippon Medical School Hospital
City
Sendagi 1-1-5
State/Province
Bunkyo-ku
ZIP/Postal Code
13 113-8603
Country
Japan
Facility Name
Chiba University Hospital
City
Chuo-ku Inohana 1-8-1
State/Province
Chiba-shi
ZIP/Postal Code
12 260-8677
Country
Japan
Facility Name
Hokkaido University Hospital
City
Sapporo-shi
State/Province
Hokkaidō Prefecture
ZIP/Postal Code
01 060-8648
Country
Japan
Facility Name
Tokai University Hospital
City
Isehara-shi
State/Province
Kanagawa Prefecture
ZIP/Postal Code
259-1143
Country
Japan
Facility Name
Gunma University Hospital
City
Showa-machi 3-39-15
State/Province
Maebashi-shi
ZIP/Postal Code
10 371-8511
Country
Japan
Facility Name
NHO Tokyo Medical Center
City
Higashigaoka 2-5-1
State/Province
Meguro-ku
ZIP/Postal Code
13 152-8902
Country
Japan
Facility Name
Mie University Hospital
City
Tsu-shi
State/Province
Mie
ZIP/Postal Code
514-8507
Country
Japan
Facility Name
University of Miyazaki Hospital
City
Miyazaki-shi
State/Province
Miyazaki
ZIP/Postal Code
889-1692
Country
Japan
Facility Name
Niigata Cancer Centre
City
Niigata-shi
State/Province
Niigata
ZIP/Postal Code
951-8566
Country
Japan
Facility Name
Okayama University Hospital
City
Okayama-shi
State/Province
Okayama Prefecture
ZIP/Postal Code
33 700-8558
Country
Japan
Facility Name
Osaka City University Hospital
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
545-0051
Country
Japan
Facility Name
Osaka University Hospital
City
Suita-shi
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Juntendo University Shizuoka Hospital
City
Izunokuni-shi
State/Province
Shizuoka Prefecture
ZIP/Postal Code
22 410-2295
Country
Japan
Facility Name
Keio University Hospital
City
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
30121892
Citation
Kanakura Y, Shirasugi Y, Yamaguchi H, Koike M, Chou T, Okamoto S, Achenbach H, Wu J, Nakaseko C. A phase 3b, multicenter, open-label extension study of the long-term safety of anagrelide in Japanese adults with essential thrombocythemia. Int J Hematol. 2018 Nov;108(5):491-498. doi: 10.1007/s12185-018-2510-7. Epub 2018 Aug 18.
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Long-term Safety of SPD422 in Japanese Adults With Essential Thrombocythaemia
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