Phase 3
N=53
Effect of SPD422 on Platelet Lowering and Safety in Japanese Adults With At Risk Essential Thrombocythaemia
Essential Thrombocythemia (ET)
Bottom Line
View on ClinicalTrials.gov: NCT01214915 ↗Enrolled (actual)
53
Serious AEs
28.3%
Results posted
Sep 2013
Primary outcome: Primary: Percentage of Subjects Who Responded in Platelet Count — 67.9 percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Anagrelide Hydrochloride (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Shire
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects Who Responded in Platelet Count |
67.9 | — |
| SECONDARY Percentage of Subjects With at Least 50% Reduction in Platelet Count |
50.9 | — |
| SECONDARY Percentage of Subjects With Normalization in Platelet Count |
45.3 | — |
| SECONDARY Percentage of Subjects Who Responded in Platelet Count Whose Baseline Platelet Count Was ≥600x10^9/L |
68.1 | — |
| SECONDARY Percentage of Subjects Who Responded in Platelet Count Whose Baseline Platelet Count Was <600x10^9/L |
66.7 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01214915). 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.