Effect of SPD422 on Platelet Lowering and Safety in Japanese Adults With At Risk Essential Thrombocythaemia
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
1 other identifier
interventional
53
1 country
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2010
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 4, 2010
CompletedFirst Posted
Study publicly available on registry
October 5, 2010
CompletedStudy Start
First participant enrolled
October 27, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 24, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 24, 2012
CompletedResults Posted
Study results publicly available
September 25, 2013
CompletedJune 9, 2021
May 1, 2021
2 years
October 4, 2010
July 24, 2013
May 24, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Subjects Who Responded in Platelet Count
A response was defined as platelet counts to \<600x10\^9/L across consecutive visits for at least 4 weeks following at least 3 months of treatment.
12 months
Secondary Outcomes (4)
Percentage of Subjects With at Least 50% Reduction in Platelet Count
12 months
Percentage of Subjects With Normalization in Platelet Count
12 months
Percentage of Subjects Who Responded in Platelet Count Whose Baseline Platelet Count Was ≥600x10^9/L
12 months
Percentage of Subjects Who Responded in Platelet Count Whose Baseline Platelet Count Was <600x10^9/L
12 months
Study Arms (1)
Anagrelide Hydrochloride
EXPERIMENTALInterventions
Subjects will be started at 1.0 mg per day and titrated as necessary.
Eligibility Criteria
You may qualify if:
- Subjects must have previously been treated with a cytoreductive therapy and been intolerant or refractory to that therapy.
You may not qualify if:
- Subjects should not have any other underlying conditions or medications that would confound the study analysis or interact with the study medication.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirelead
Study Sites (19)
Akita University Hospital
Akita, Akita, 05 010-8543, Japan
Juntendo University Hospital
Hongo 3-1-3, Bunkyo-ku, 13 113-8431, Japan
Tokyo Metropolitan Cancer and Infectious diseases Center Kom
Honkomagome 3-18-22, Bunkyo-ku, 13 113-8677, Japan
Nippon Medical School Hospital
Sendagi 1-1-5, Bunkyo-ku, 13 113-8603, Japan
Chiba University Hospital
Chuo-ku Inohana 1-8-1, Chiba-shi, 12 260-8677, Japan
NHO Nagoya Medical Center
Nagoya, Chubu, 23 460-0001, Japan
Hokkaido University Hospital
Sapporo, Hokkaidō Prefecture, 01 060-8648, Japan
Juntendo University Shizuoka Hospital
Nagaoka, Izunokuni-shi, 22 410-2295, Japan
Tokai University Hospital
Isehara-shi, Kanagawa, 259-1143, Japan
Osaka City University Hospital
Osaka, Kansai, 27 545-8586, Japan
Gunma University Hospital
Showa-machi 3-39-15, Maebashi-shi, 10 371-8511, Japan
NHO Tokyo Medical Center
Higashigaoka 2-5-1, Meguro-ku, 13 152-8902, Japan
Mie University Hospital
Tsu, Mie-ken, 514-8507, Japan
University of Miyazaki Hospital
Miyazaki, Miyazaki, 889-1692, Japan
Niigata Cancer Center Hospital
Chuo-ku Kawagishi-cho 2-15-3, Niigata-shi, 15 951-8566, Japan
Okayama University Hospital
Okayama, Okayama-ken, 33 700-8558, Japan
Osaka University Hospital
Suita-shi, Osaka, 27 565-0871, Japan
Tokushima University Hospital
Tokushima, Tokushima Perfecture, 770-8503, Japan
Keio University Hospital
Tokyo, 13 160-8582, Japan
Related Publications (1)
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.
PMID: 25160063RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Shire
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 4, 2010
First Posted
October 5, 2010
Study Start
October 27, 2010
Primary Completion
October 24, 2012
Study Completion
October 24, 2012
Last Updated
June 9, 2021
Results First Posted
September 25, 2013
Record last verified: 2021-05