Status:
COMPLETED
French Observational Xagrid (FOX) Study In Adult Patients With Essential Thrombocythemia
Lead Sponsor:
Shire
Conditions:
Essential Thrombocythemia
Eligibility:
All Genders
18+ years
Brief Summary
This is an observational study to explore how different treatment regimens affect continuation with treatment in the first 6 months following initiation of XAGRID into adult patients' essential thromb...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Patients aged 18 years and older.
- High-risk ET Patients, uncontrolled by first-line (or previous) cytoreductive treatment for efficacy or tolerance reasons.
- Patients who have been on second- or third-line XAGRID treatment for up to 1 month, or for whom a decision has been documented to commence second line XAGRID treatment.
- Patients able to understand and able and willing to participate in the study, and provide a personally dated and signed written informed consent form.
- Exclusion Criteria
- Patients with a known or suspected intolerance or hypersensitivity to XAGRID, closely related compounds, or any of the stated ingredients.
- Patients for whom there is an intention to treat with combinations of cytoreductive therapy.
- Patients participating in a separate clinical trial where their treatment is defined by that study protocol.
Exclusion
Key Trial Info
Start Date :
September 13 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 21 2012
Estimated Enrollment :
177 Patients enrolled
Trial Details
Trial ID
NCT01192347
Start Date
September 13 2010
End Date
December 21 2012
Last Update
June 14 2021
Active Locations (46)
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1
GH Pitie Salpetriere
Paris, Cedex 13, France, 75651
2
CH DU Pays D Aix
Aix-en-Provence, Cedex 1, France, 13616
3
Hopital Dupuytren
Limoges, Cedex 1, France, 87042
4
Hopital Emile Muller
Mulhouse, Cedex 1, France, 68070