Clinical trial NCT01214915: Effect of SPD422 on Platelet Lowering and Safety in Japanese Adults With At Risk Essential Thrombocythaemia
Official title: A Phase 3, Open-label, Single-arm Study Evaluating the Effect of SPD422 on Platelet Lowering and Safety in Japanese Adults With At Risk Essential Thrombocythaemia Who Are Intolerant or Refractory to Current Cytoreductive Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Essential Thrombocythemia (ET)
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2010-10-05
Enrollment: 53
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 investigate how effective and safe SPD422 (Anagrelide Hydrochloride) is in Japanese subjects, diagnosed with Essential Thrombocythemia, who's previously treatment has either not been effective or has caused unacceptable adverse reactions. The study will aim to show that platelet counts can be safely reduced in treated patients to below 600 x 10\^9/L after a minimum of three months treatment. To demonstrate an positive effect platelet levels will need to remain below 600 x 10\^9/L for at least 4 weeks.


Eligibility criteria: Inclusion Criteria:

* Subjects must have previously been treated with a cytoreductive therapy and been intolerant or refractory to that therapy.

Exclusion Criteria:

* Subjects should not have any other underlying conditions or medications that would confound the study analysis or interact with the study medication.

Primary outcomes:
measure: Percentage of Subjects Who Responded in Platelet Count
timeFrame: 12 months
Secondary outcomes:
measure: Percentage of Subjects With at Least 50% Reduction in Platelet Count
timeFrame: 12 months
measure: Percentage of Subjects With Normalization in Platelet Count
timeFrame: 12 months
measure: Percentage of Subjects Who Responded in Platelet Count Whose Baseline Platelet Count Was ≥600x10^9/L
timeFrame: 12 months
measure: Percentage of Subjects Who Responded in Platelet Count Whose Baseline Platelet Count Was <600x10^9/L
timeFrame: 12 months
Other outcomes:
Locations:
city: Akita-shi
country: Japan
facility: Akita University Hospital
state: Akita Prefecture
city: Hongo 3-1-3
country: Japan
facility: Juntendo University Hospital
state: Bunkyo-ku
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: Nagoya-shi
country: Japan
facility: NHO Nagoya Medical Center
state: Chubu
city: Sapporo-shi
country: Japan
facility: Hokkaido University Hospital
state: Hokkaidō Prefecture
city: Nagaoka 1129
country: Japan
facility: Juntendo University Shizuoka Hospital
state: Izunokuni-shi
city: Isehara-shi
country: Japan
facility: Tokai University Hospital
state: Kanagawa Prefecture
city: Osaka-shi
country: Japan
facility: Osaka City University Hospital
state: Kansai
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, 24
country: Japan
facility: Mie University Hospital
state: Mie
city: Miyazaki-shi
country: Japan
facility: University of Miyazaki Hospital
state: Miyazaki Prefecture
city: Chuo-ku Kawagishi-cho 2-15-3
country: Japan
facility: Niigata Cancer Center Hospital
state: Niigata-shi
city: Okayama-shi
country: Japan
facility: Okayama University Hospital
state: Okayama Prefecture
city: Suita-shi
country: Japan
facility: Osaka University Hospital
state: Osaka Prefecture
city: Tokushima-shi
country: Japan
facility: Tokushima University Hospital
state: Tokushima Perfecture
city: Tokyo
country: Japan
facility: Keio University Hospital
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: Kanakura Y, Miyakawa Y, Wilde P, Smith J, Achenbach H, Okamoto S. Phase III, single-arm study investigating the efficacy, safety, and tolerability of anagrelide as a second-line treatment in high-risk Japanese patients with essential thrombocythemia. Int J Hematol. 2014 Oct;100(4):353-60. doi: 10.1007/s12185-014-1631-x. Epub 2014 Aug 27.