Back to resultsEffect of SPD422 on Platelet Lowering and Safety in Japanese Adults With At Risk Essential Thrombocythaemia
Primary Purpose
Essential Thrombocythemia (ET)
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Anagrelide Hydrochloride
Sponsored by
About this trial
This is an interventional treatment trial for Essential Thrombocythemia (ET)
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.
Sites / Locations
- Akita University Hospital
- Juntendo University Hospital
- Tokyo Metropolitan Cancer and Infectious diseases Center Kom
- Nippon Medical School Hospital
- Chiba University Hospital
- NHO Nagoya Medical Center
- Hokkaido University Hospital
- Juntendo University Shizuoka Hospital
- Tokai University Hospital
- Osaka City University Hospital
- Gunma University Hospital
- NHO Tokyo Medical Center
- Mie University Hospital
- University of Miyazaki Hospital
- Niigata Cancer Center Hospital
- Okayama University Hospital
- Osaka University Hospital
- Tokushima University Hospital
- Keio University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Anagrelide Hydrochloride
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Percentage of Subjects With at Least 50% Reduction in Platelet Count
Subjects who achieved at least 50% reduction in platelet count from their baseline level across consecutive visits for at least 4 weeks and following 3 months of treatment.
Percentage of Subjects With Normalization in Platelet Count
Normalization was defined as platelet counts ≤400x10^9/L across consecutive visits for at least 4 weeks following at least 3 months of treatment.
Percentage of Subjects Who Responded in Platelet Count Whose Baseline Platelet Count Was ≥600x10^9/L
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.
Percentage of Subjects Who Responded in Platelet Count Whose Baseline Platelet Count Was <600x10^9/L
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01214915
Brief Title
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
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
October 27, 2010 (Actual)
Primary Completion Date
October 24, 2012 (Actual)
Study Completion Date
October 24, 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shire
4. Oversight
5. Study Description
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.
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
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anagrelide Hydrochloride
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Anagrelide Hydrochloride
Other Intervention Name(s)
SPD422
Intervention Description
Subjects will be started at 1.0 mg per day and titrated as necessary.
Primary Outcome Measure Information:
Title
Percentage of Subjects Who Responded in Platelet Count
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Percentage of Subjects With at Least 50% Reduction in Platelet Count
Description
Subjects who achieved at least 50% reduction in platelet count from their baseline level across consecutive visits for at least 4 weeks and following 3 months of treatment.
Time Frame
12 months
Title
Percentage of Subjects With Normalization in Platelet Count
Description
Normalization was defined as platelet counts ≤400x10^9/L across consecutive visits for at least 4 weeks following at least 3 months of treatment.
Time Frame
12 months
Title
Percentage of Subjects Who Responded in Platelet Count Whose Baseline Platelet Count Was ≥600x10^9/L
Description
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.
Time Frame
12 months
Title
Percentage of Subjects Who Responded in Platelet Count Whose Baseline Platelet Count Was <600x10^9/L
Description
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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.
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 Prefecture
ZIP/Postal Code
05 010-8543
Country
Japan
Facility Name
Juntendo University Hospital
City
Hongo 3-1-3
State/Province
Bunkyo-ku
ZIP/Postal Code
13 113-8431
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
NHO Nagoya Medical Center
City
Nagoya-shi
State/Province
Chubu
ZIP/Postal Code
23 460-0001
Country
Japan
Facility Name
Hokkaido University Hospital
City
Sapporo-shi
State/Province
Hokkaidō Prefecture
ZIP/Postal Code
01 060-8648
Country
Japan
Facility Name
Juntendo University Shizuoka Hospital
City
Nagaoka 1129
State/Province
Izunokuni-shi
ZIP/Postal Code
22 410-2295
Country
Japan
Facility Name
Tokai University Hospital
City
Isehara-shi
State/Province
Kanagawa Prefecture
ZIP/Postal Code
259-1143
Country
Japan
Facility Name
Osaka City University Hospital
City
Osaka-shi
State/Province
Kansai
ZIP/Postal Code
27 545-8586
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, 24
State/Province
Mie
ZIP/Postal Code
514-8507
Country
Japan
Facility Name
University of Miyazaki Hospital
City
Miyazaki-shi
State/Province
Miyazaki Prefecture
ZIP/Postal Code
889-1692
Country
Japan
Facility Name
Niigata Cancer Center Hospital
City
Chuo-ku Kawagishi-cho 2-15-3
State/Province
Niigata-shi
ZIP/Postal Code
15 951-8566
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 University Hospital
City
Suita-shi
State/Province
Osaka Prefecture
ZIP/Postal Code
27 565-0871
Country
Japan
Facility Name
Tokushima University Hospital
City
Tokushima-shi
State/Province
Tokushima Perfecture
ZIP/Postal Code
770-8503
Country
Japan
Facility Name
Keio University Hospital
City
Tokyo
ZIP/Postal Code
13 160-8582
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
25160063
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.
Results Reference
result
Learn more about this trial
Effect of SPD422 on Platelet Lowering and Safety in Japanese Adults With At Risk Essential Thrombocythaemia
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