N/A
N=47
Exploratory Multi-centre Trial In Patients With ET Treated With XAGRID®
Essential Thrombocythemia (ET)
Bottom Line
View on ClinicalTrials.gov: NCT01352585 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcome: Primary: Number of Patients With Platelet Count ≤600x10^9/L After 12 Months — 12; 14 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Anagrelide hydrochloride (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Shire
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Platelet Count ≤600x10^9/L After 12 Months |
12; 14 | — |
| SECONDARY Number of Patients With Platelet Count ≤400x10^9/L After 12 Months |
7; 8 | — |
| SECONDARY Platelet Count |
458.9; 503.0 | — |
| SECONDARY Red Blood Cell (RBC) Count |
4.85; 4.24 | — |
| SECONDARY White Blood Cell (WBC) Count |
7.75; 8.77 | — |
| SECONDARY Differential WBC Count - Neutrophils, Lymphocytes, Monocytes, and Basophils. |
62.05; 60.07; 27.53; 28.76; 6.50; 7.21 | — |
| SECONDARY Differential WBC Count - Eosinophils |
2.95; 2.77 | — |
| SECONDARY Hemoglobin Concentration |
133.6; 120.2 | — |
| SECONDARY Hematocrit Level |
0.412; 0.367 | — |
Summary
This study is hypothesis-generating to explore the impact of JAK2 (V617F) mutation status on the treatment response to anagrelide hydrochloride
Eligibility Criteria
Inclusion Criteria
- Patients must be able to understand and willing to participate in the study, and provide a personally dated and signed written informed consent form.
- Patients must have a confirmed diagnosis of ET according to the World health Organisation's criteria.
- ET patients who are uncontrolled, in the Investigator's opinion, by first-line (or previous) cytoreductive treatment for efficacy or tolerance reasons.
- Patients who have either commenced treatment with anagrelide hydrochloride in the last 7 days or for whom a decision has been documented to commence treatment with anagrelide hydrochloride
Exclusion Criteria
- Patients for whom treatment with anagrelide hydrochloride is contraindicated, according to the current XAGRID SmPC.
- Known or suspected intolerance or hypersensitivity to the product, closely related compounds, or any of the stated ingredients.
- Patients participating in an interventional research study.
- Patients on combination therapy or for whom there is an intention to treat with other cytoreductive agents e.g., hydroxyurea, interferon. Patients can however use aspirin and other anti-aggregatory products at the Investigator's discretion.
Data sourced from ClinicalTrials.gov (NCT01352585). 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.