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

Essential Thrombocythemia (ET) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01467661
• Other study ID #: SPD422-309
• Status: Completed
• Phase: Phase 3
• Start date: October 27, 2010
• Est. completion date: May 1, 2015

Study information

• Verified date: May 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: May 1, 2015
• Est. primary completion date: May 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Subjects must have completed Study SPD422 308

Related Conditions & MeSH terms

• Essential Thrombocythemia (ET)
• Thrombocythemia, Essential
• Thrombocytosis

Intervention

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.

Locations

Country	Name	City	State
Japan	Akita University Hospital	Akita-shi	Akita
Japan	Chiba University Hospital	Chuo-ku Inohana 1-8-1	Chiba-shi
Japan	NHO Tokyo Medical Center	Higashigaoka 2-5-1	Meguro-ku
Japan	Tokyo Metropolitan Cancer and Infectious diseases Center Kom	Honkomagome 3-18-22	Bunkyo-ku
Japan	Tokai University Hospital	Isehara-shi	Kanagawa Prefecture
Japan	Juntendo University Shizuoka Hospital	Izunokuni-shi	Shizuoka Prefecture
Japan	University of Miyazaki Hospital	Miyazaki-shi	Miyazaki
Japan	Niigata Cancer Centre	Niigata-shi	Niigata
Japan	Okayama University Hospital	Okayama-shi	Okayama Prefecture
Japan	Osaka City University Hospital	Osaka-shi	Osaka
Japan	Hokkaido University Hospital	Sapporo-shi	Hokkaido Prefecture
Japan	Nippon Medical School Hospital	Sendagi 1-1-5	Bunkyo-ku
Japan	Gunma University Hospital	Showa-machi 3-39-15	Maebashi-shi
Japan	Osaka University Hospital	Suita-shi	Osaka
Japan	Keio University Hospital	Tokyo
Japan	Mie University Hospital	Tsu-shi	Mie

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Country where clinical trial is conducted

Japan, 

References & Publications (1)

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. 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline and final assessment (within 5 days of the last dose of investigational product)
Primary	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).	Baseline and final assessment (within 5 days of the last dose of investigational product)
Primary	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.	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)
Primary	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.	Baseline and final assessment (within 5 days of the last dose of investigational product)
Primary	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.	Baseline and final assessment (within 5 days of the last dose of investigational product)
Primary	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.	Baseline and final assessment (within 5 days of the last dose of investigational product)
Primary	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.	From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product
Primary	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.	From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product
Primary	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.	From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product
Primary	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.	From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product
Primary	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.	From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product
Primary	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.	From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product
Primary	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.	From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product