Phase 3 N=53 Treatment

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

Essential Thrombocythemia (ET)

Bottom Line

View on ClinicalTrials.gov: NCT01467661 ↗

Enrolled (actual)

Serious AEs

25.6%

Results posted

Jun 2016

Primary outcome: Primary: Change From Baseline in Platelet Count at Final Assessment — 1021.6; -346.2 10^9 platelets per liter (10^9/L)

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: SPD422 (anagrelide hydrochloride) (Drug)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: Shire
Primary completion: May 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Platelet Count at Final Assessment	1021.6; -346.2	—
PRIMARY Change From Baseline in Platelet Count During Post-marketing Trial at Final Assessment	1088.3; -647.9	—
PRIMARY Percentage of Participants Who Achieved Platelet Count Less Than (<) 600	11.3; 17.0; 42.9; 50.0; 54.3; 60.0	—
PRIMARY Percentage of Participants Who Achieved Platelet Count Less Than (<) 600 During Post-marketing Trial	12.1; 80.6	—
PRIMARY Percentage of Participants Who Achieved Shift From Baseline in Platelet Count	9.4; 1.9; 50.9; 37.7	—
PRIMARY Percentage of Participants Who Achieved Shift From Baseline in Platelet Count During Post-marketing Trial	9.7; 0.0; 71.0; 19.4	—
PRIMARY Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)	100; 39.6	—
PRIMARY Percentage of Participants With TEAEs and TESAEs During Post-marketing Trial	39.4; 3.0	—
PRIMARY Percentage of Participants With TEAEs and TESAEs Related to Clinical Laboratory Result	73.6; 1.9	—
PRIMARY Percentage of Participants With TEAEs and TESAEs Related to Clinical Laboratory Result During Post-marketing Trial	0; 0	—
PRIMARY Percentage of Participants With TEAEs and TESAEs Related to Vital Signs	5.7; 0	—
PRIMARY Percentage of Participants With TEAEs and TESAEs Related to Vital Signs During Post-marketing Trial	3.0; 0	—
PRIMARY Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities	11	—

Summary

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.

Eligibility Criteria

Inclusion Criteria

Subjects must have completed Study SPD422 308

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01467661). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.