Phase 3
Completed N=53
Long-term Safety of SPD422 in Japanese Adults With Essential Thrombocythaemia
Essential Thrombocythemia (ET)
Source: ClinicalTrials.gov NCT01467661 ↗
Enrolled (actual)
53
Serious AEs
25.6%
Results posted
Jun 2016
Primary outcomePrimary: Change From Baseline in Platelet Count at Final Assessment — 1021.6; -346.2 10^9 platelets per liter (10^9/L)
◆ Published Evidence
Emerging
7citations · ~1 / year
A phase 3b, multicenter, open-label extension study of the long-term safety of anagrelide in Japanese adults with essential thrombocythemia.
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.
Linked Publications
-
A phase 3b, multicenter, open-label extension study of the long-term safety of anagrelide in Japanese adults with essential thrombocythemia.
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 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects must have completed Study SPD422 308
Data sourced from ClinicalTrials.gov (NCT01467661) and the linked publication. 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. Informational only — not medical advice.