Clinical trial NCT01467661: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Essential Thrombocythemia (ET)
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2011-11-09
Enrollment: 41
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Subjects must have completed Study SPD422 308

Primary outcomes:
measure: Change From Baseline in Platelet Count at Final Assessment
timeFrame: Baseline and final assessment (within 5 days of the last dose of investigational product)
measure: Change From Baseline in Platelet Count During Post-marketing Trial at Final Assessment
timeFrame: Baseline and final assessment (within 5 days of the last dose of investigational product)
measure: Percentage of Participants Who Achieved Platelet Count Less Than (<) 600
timeFrame: 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)
measure: Percentage of Participants Who Achieved Platelet Count Less Than (<) 600 During Post-marketing Trial
timeFrame: Baseline and final assessment (within 5 days of the last dose of investigational product)
measure: Percentage of Participants Who Achieved Shift From Baseline in Platelet Count
timeFrame: Baseline and final assessment (within 5 days of the last dose of investigational product)
measure: Percentage of Participants Who Achieved Shift From Baseline in Platelet Count During Post-marketing Trial
timeFrame: Baseline and final assessment (within 5 days of the last dose of investigational product)
measure: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
timeFrame: From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product
measure: Percentage of Participants With TEAEs and TESAEs During Post-marketing Trial
timeFrame: From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product
measure: Percentage of Participants With TEAEs and TESAEs Related to Clinical Laboratory Result
timeFrame: From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product
measure: Percentage of Participants With TEAEs and TESAEs Related to Clinical Laboratory Result During Post-marketing Trial
timeFrame: From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product
measure: Percentage of Participants With TEAEs and TESAEs Related to Vital Signs
timeFrame: From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product
measure: Percentage of Participants With TEAEs and TESAEs Related to Vital Signs During Post-marketing Trial
timeFrame: From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product
measure: Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
timeFrame: From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product
Secondary outcomes:
Other outcomes:
Locations:
city: Akita-shi
country: Japan
facility: Akita University Hospital
state: Akita
city: Honkomagome 3-18-22
country: Japan
facility: Tokyo Metropolitan Cancer and Infectious diseases Center Kom
state: Bunkyo-ku
city: Sendagi 1-1-5
country: Japan
facility: Nippon Medical School Hospital
state: Bunkyo-ku
city: Chuo-ku Inohana 1-8-1
country: Japan
facility: Chiba University Hospital
state: Chiba-shi
city: Sapporo-shi
country: Japan
facility: Hokkaido University Hospital
state: Hokkaidō Prefecture
city: Isehara-shi
country: Japan
facility: Tokai University Hospital
state: Kanagawa Prefecture
city: Showa-machi 3-39-15
country: Japan
facility: Gunma University Hospital
state: Maebashi-shi
city: Higashigaoka 2-5-1
country: Japan
facility: NHO Tokyo Medical Center
state: Meguro-ku
city: Tsu-shi
country: Japan
facility: Mie University Hospital
state: Mie
city: Miyazaki-shi
country: Japan
facility: University of Miyazaki Hospital
state: Miyazaki
city: Niigata-shi
country: Japan
facility: Niigata Cancer Centre
state: Niigata
city: Okayama-shi
country: Japan
facility: Okayama University Hospital
state: Okayama Prefecture
city: Osaka-shi
country: Japan
facility: Osaka City University Hospital
state: Osaka
city: Suita-shi
country: Japan
facility: Osaka University Hospital
state: Osaka
city: Izunokuni-shi
country: Japan
facility: Juntendo University Shizuoka Hospital
state: Shizuoka Prefecture
city: Tokyo
country: Japan
facility: Keio University Hospital
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
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.