Effect of SPD422 on Platelet Lowering and Safety in Japanese Adults With At Risk Essential Thrombocythaemia

Essential Thrombocythemia (ET) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01214915
• Other study ID #: SPD422-308
• Status: Completed
• Phase: Phase 3
• Start date: October 27, 2010
• Est. completion date: October 24, 2012

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: October 24, 2012
• Est. primary completion date: October 24, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Anagrelide Hydrochloride
Subjects will be started at 1.0 mg per day and titrated as necessary.

Locations

Country	Name	City	State
Japan	Akita University Hospital	Akita-shi	Akita Prefecture
Japan	Chiba University Hospital	Chuo-ku Inohana 1-8-1	Chiba-shi
Japan	Niigata Cancer Center Hospital	Chuo-ku Kawagishi-cho 2-15-3	Niigata-shi
Japan	NHO Tokyo Medical Center	Higashigaoka 2-5-1	Meguro-ku
Japan	Juntendo University Hospital	Hongo 3-1-3	Bunkyo-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	University of Miyazaki Hospital	Miyazaki-shi	Miyazaki Prefecture
Japan	Juntendo University Shizuoka Hospital	Nagaoka 1129	Izunokuni-shi
Japan	NHO Nagoya Medical Center	Nagoya-shi	Chubu
Japan	Okayama University Hospital	Okayama-shi	Okayama Prefecture
Japan	Osaka City University Hospital	Osaka-shi	Kansai
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 Prefecture
Japan	Tokushima University Hospital	Tokushima-shi	Tokushima Perfecture
Japan	Keio University Hospital	Tokyo
Japan	Mie University Hospital	Tsu-shi, 24	Mie

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Country where clinical trial is conducted

Japan, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	12 months
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	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.	12 months