Long-term Safety of SPD422 in Japanese Adults With Essential Thrombocythaemia

Shire

Status and phase: Completed; Phase 3

Conditions: Essential Thrombocythemia (ET)

Treatments: Drug: SPD422 (anagrelide hydrochloride)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01467661

SPD422-309

Details and patient eligibility

About

The purpose of this study is to provide SPD422 to subjects who completed Study SPD422 308 and, in the opinion of the Investigator, will continue to benefit from treatment.

Enrollment: 41 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Subjects must have completed Study SPD422 308

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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41 participants in 1 patient group

SPD422 (anagrelide hydrochloride)

Experimental group

Treatment:

Drug: SPD422 (anagrelide hydrochloride)