Phase 4
N=146
A Study of Anagrelide and Hydroxyurea in High-Risk Essential Thrombocythemia Patients
Thrombocythemia, Hemorrhagic
Bottom Line
View on ClinicalTrials.gov: NCT00202644 ↗Enrolled (actual)
146
Serious AEs
20.5%
Results posted
Jan 2018
Primary outcome: Primary: Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Over Time — 66.4; 66.9; 0.5; -1.1 percentage of ejection fraction
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Anagrelide (Drug); Hydroxyurea (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Shire
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Over Time |
66.4; 66.9; 0.5; -1.1; 1.2; 0 | — |
| PRIMARY Platelet Count at Month 6 |
418.6; 396.0 | — |
| SECONDARY Change From Baseline in Platelet Counts at Month 3 and 36 |
575.3; 462.2; 531.0; 462.8 | — |
| SECONDARY Percentage of Participants With Complete Response |
58.9; 58.8 | — |
| SECONDARY Percentage of Participants With Partial Response |
21.9; 27.9 | — |
| SECONDARY Time to Complete Response |
177.0; 123.0 | — |
| SECONDARY Time to Partial Response |
61.0; 47.0 | — |
| SECONDARY Number of Participants With Thrombotic and Haemorrhagic Events |
30; 16 | — |
| SECONDARY Change From Baseline in White Blood Cell Count Over Time |
9.13; 10.20; -0.38; -5.02; -1.00; -4.79 | — |
| SECONDARY Change From Baseline in Red Blood Cell Count Over Time |
4.757; 4.787; -0.227; -1.467; -0.246; -1.398 | — |
Summary
Essential thrombocythaemia is a disorder of bone marrow, which causes too many platelets to be produced. Platelets are small cells carried around in the blood, which help form blood clots. When patients have too many platelets, there is a risk of blood clots forming unnecessarily and excessive bleeding. The aim of this study is to gain additional information on the safety profile of Anagrelide (Xagrid(r)) and Hydroxyurea (also known as hydroxycarbamide).
Eligibility Criteria
Inclusion Criteria
- Confirmed diagnosis of essential thrombocythaemia - high risk profile
- Previously untreated with a cytoreductive agent
- Females of childbearing potential must have a negative urine pregnancy test prior to entering the study and must agree to use effective birth control for the duration of the study
Exclusion Criteria
- Diagnosis of any other myeloproliferative disorder
- Any known cause for a secondary thrombocytosis
- Anti-coagulant and anti-aggregant therapies
- Known or suspected heart disease
- Left Ventricular Ejection Fraction < 55%
Data sourced from ClinicalTrials.gov (NCT00202644). 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.