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

NCT ID: NCT01214915

Last Updated: 2021-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-27
• Study Completion Date: 2012-10-24

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.

Conditions

Essential Thrombocythemia (ET)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Anagrelide Hydrochloride

Group Type: EXPERIMENTAL

Anagrelide Hydrochloride

Intervention Type: DRUG

Subjects will be started at 1.0 mg per day and titrated as necessary.

Interventions

Anagrelide Hydrochloride

Subjects will be started at 1.0 mg per day and titrated as necessary.

Intervention Type: DRUG

Other Intervention Names

SPD422

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shire

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

Akita University Hospital

Akita, Akita, 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

Nippon Medical School Hospital

Sendagi 1-1-5, Bunkyo-ku, Japan

Chiba University Hospital

Chuo-ku Inohana 1-8-1, Chiba-shi, Japan

NHO Nagoya Medical Center

Nagoya, Chubu, Japan

Hokkaido University Hospital

Sapporo, Hokkaidō Prefecture, Japan

Juntendo University Shizuoka Hospital

Nagaoka, Izunokuni-shi, Japan

Tokai University Hospital

Isehara-shi, Kanagawa, Japan

Osaka City University Hospital

Osaka, Kansai, Japan

Gunma University Hospital

Showa-machi 3-39-15, Maebashi-shi, Japan

NHO Tokyo Medical Center

Higashigaoka 2-5-1, Meguro-ku, Japan

Mie University Hospital

Tsu, Mie-ken, Japan

University of Miyazaki Hospital

Miyazaki, Miyazaki, Japan

Niigata Cancer Center Hospital

Chuo-ku Kawagishi-cho 2-15-3, Niigata-shi, Japan

Okayama University Hospital

Okayama, Okayama-ken, Japan

Osaka University Hospital

Suita-shi, Osaka, Japan

Tokushima University Hospital

Tokushima, Tokushima Perfecture, Japan

Keio University Hospital

Tokyo, , Japan

Countries

Japan

References

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.

Reference Type: RESULT

PMID: 25160063 (View on PubMed)

Other Identifiers

SPD422-308

Identifier Type: -

Identifier Source: org_study_id