French Observational Xagrid (FOX) Study In Adult Patients With Essential Thrombocythemia
- Conditions
- Essential Thrombocythemia
- Registration Number
- NCT01192347
- Lead Sponsor
- Shire
- 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 thrombocythemia therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 177
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: When the Dosing Was Consistent With the Summary of Product Characteristics (SmPC) 6 months Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when XAGRID treatment was initiated, using the following variables: •Initiation of XAGRID dosing consistent with the Summary of Product Characteristics (SmPC): •Consistent if: -The starting dose was \<=1 mg/day, AND -Any increase in dose was no more than 0.5mg/day, AND -Any increase in dose was made at least 7 days after first initiation or at least 7 days after any previous modification (up or down), AND -The maximum dose did not exceed 10 mg/day at any stage. •Inconsistent: in all other cases
Percentage of Subjects Achieving Platelet Target Response: Withdrawal of Previous Cytoreductive Therapy Before Anagrelide Hydrochloride Initiation 6 months Full response is a platelet count of \<400x10\^9/L. Partial response is a platelet count between 400-600x10\^9/L or a platelet count reduction of 200x10\^9. Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables: •Withdrawal of previous cytoreductive therapy: -Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation -After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up -Not Withdrawn: in all other cases
Percentage of Subjects Achieving Platelet Target Response: When the Dosing Was Inconsistent With the Summary of Product Characteristics (SmPC) 6 months Full response is a platelet count of \<400x10\^9/L. Partial response is a platelet count between 400-600x10\^9/L or a platelet count reduction of 200x10\^9. Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when XAGRID treatment was initiated, using the following variables: •Initiation of XAGRID dosing consistent with the Summary of Product Characteristics (SmPC): •Consistent if: -The starting dose was \<=1 mg/day, AND -Any increase in dose was no more than 0.5mg/day, AND -Any increase in dose was made at least 7 days after first initiation or at least 7 days after any previous modification (up or down), AND -The maximum dose did not exceed 10 mg/day at any stage. •Inconsistent: in all other cases
Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: Withdrawal of Previous Cytoreductive Therapy Before Anagrelide Hydrochloride Initiation 6 months Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables: •Withdrawal of previous cytoreductive therapy: -Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation -After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up -Not Withdrawn: in all other cases
Percentage of Subjects Achieving Platelet Target Response: Withdrawal of Previous Cytoreductive Therapy After Anagrelide Hydrochloride Initiation 6 months Full response is a platelet count of \<400x10\^9/L. Partial response is a platelet count between 400-600x10\^9/L or a platelet count reduction of 200x10\^9. Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables: •Withdrawal of previous cytoreductive therapy: -Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation -After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up -Not Withdrawn: in all other cases
Percentage of Subjects Achieving Platelet Target Response: When the Dosing Was Consistent With the Summary of Product Characteristics (SmPC) 6 months Full response is a platelet count of \<400x10\^9/L. Partial response is a platelet count between 400-600x10\^9/L or a platelet count reduction of 200x10\^9. Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when XAGRID treatment was initiated, using the following variables: •Initiation of XAGRID dosing consistent with the Summary of Product Characteristics (SmPC): •Consistent if: -The starting dose was \<=1 mg/day, AND -Any increase in dose was no more than 0.5mg/day, AND -Any increase in dose was made at least 7 days after first initiation or at least 7 days after any previous modification (up or down), AND -The maximum dose did not exceed 10 mg/day at any stage. •Inconsistent: in all other cases
Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: Withdrawal of Previous Cytoreductive Therapy After Anagrelide Hydrochloride Initiation 6 months Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables: •Withdrawal of previous cytoreductive therapy: -Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation -After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up -Not Withdrawn: in all other cases
Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: No Withdrawal of Previous Cytoreductive Therapy 6 months Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables: •Withdrawal of previous cytoreductive therapy: -Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation -After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up -Not Withdrawn: in all other cases
Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: When the Dosing Was Inconsistent With the Summary of Product Characteristics (SmPC) 6 months Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when XAGRID treatment was initiated, using the following variables: •Initiation of XAGRID dosing consistent with the Summary of Product Characteristics (SmPC): •Consistent if: -The starting dose was \<=1 mg/day, AND -Any increase in dose was no more than 0.5mg/day, AND -Any increase in dose was made at least 7 days after first initiation or at least 7 days after any previous modification (up or down), AND -The maximum dose did not exceed 10 mg/day at any stage. •Inconsistent: in all other cases
Percentage of Subjects Achieving Platelet Target Response: No Withdrawal of Previous Cytoreductive Therapy 6 months Full response is a platelet count of \<400x10\^9/L. Partial response is a platelet count between 400-600x10\^9/L or a platelet count reduction of 200x10\^9. Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables: •Withdrawal of previous cytoreductive therapy: -Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation -After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up -Not Withdrawn: in all other cases
- Secondary Outcome Measures
Name Time Method Number of Subjects With Anagrelide Hydrochloride Titration Modifcations- First Modification Only 6 months Percentage of Subjects With Anagrelide Hydrochloride Starting Doses 6 months Summary of Adverse Drug Reactions: No Withdrawal of Previous Cytoreductive Therapy 6 months Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables: •Withdrawal of previous cytoreductive therapy: -Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation -After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up -Not Withdrawn: in all other cases
Summary of Adverse Drug Reactions (ADR): Withdrawal of Previous Cytoreductive Therapy Before Anagrelide Hydrochloride Initiation 6 months Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables: •Withdrawal of previous cytoreductive therapy: -Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation -After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up -Not Withdrawn: in all other cases
Summary of Adverse Drug Reactions: When the Dosing Was Inconsistent With the Summary of Product Characteristics (SmPC) 6 months Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when XAGRID treatment was initiated, using the following variables: •Initiation of XAGRID dosing consistent with the Summary of Product Characteristics (SmPC): •Consistent if: -The starting dose was \<=1 mg/day, AND -Any increase in dose was no more than 0.5mg/day, AND -Any increase in dose was made at least 7 days after first initiation or at least 7 days after any previous modification (up or down), AND -The maximum dose did not exceed 10 mg/day at any stage. •Inconsistent: in all other cases
Summary of Adverse Drug Reactions: Withdrawal of Previous Cytoreductive Therapy After Anagrelide Hydrochloride Initiation 6 months Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables: •Withdrawal of previous cytoreductive therapy: -Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation -After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up -Not Withdrawn: in all other cases
Summary of Adverse Drug Reactions: When the Dosing Was Consistent With the Summary of Product Characteristics (SmPC) 6 months Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when XAGRID treatment was initiated, using the following variables: •Initiation of XAGRID dosing consistent with the Summary of Product Characteristics (SmPC): •Consistent if: -The starting dose was \<=1 mg/day, AND -Any increase in dose was no more than 0.5mg/day, AND -Any increase in dose was made at least 7 days after first initiation or at least 7 days after any previous modification (up or down), AND -The maximum dose did not exceed 10 mg/day at any stage. •Inconsistent: in all other cases
Maximum Daily Dose of Anagrelide Hydrochloride 6 months
Trial Locations
- Locations (45)
Ch D Arras
🇫🇷Arras, Cedex, France
CH De Blois
🇫🇷Blois, Cedex, France
CH DU Pays D Aix
🇫🇷Aix En Provence, Cedex 1, France
Hopital Emile Muller
🇫🇷Mulhouse, Cedex 1, France
GH Pitie Salpetriere
🇫🇷Paris, Cedex, France
Hopital Hotel Dieu Et Hme
🇫🇷Nantes, Cedex 1, France
Hopital Dupuytren
🇫🇷Limoges, Cedex 1, France
Hopital Tenon
🇫🇷Paris, Cedex 20, France
Nouvelles Cliniques Nantaises
🇫🇷Nantes, Cedex 2, France
Clinique Du Parc
🇫🇷Caen, Cedex 4, France
Hopital Hautepierre
🇫🇷Strasbourg, Cedex 2, France
Hotel Dieu
🇫🇷Angers, Cedex 9, France
Hopital De L Archet
🇫🇷Nice, Cedex 3, France
Hia Sainte Anne
🇫🇷Toulon, Cedex 9, France
Hopital Pontchaillou
🇫🇷Rennes, Cedex 9, France
CH Departemental Des Oudairies
🇫🇷La Roche Sur Yon, Cedex 9, France
Hopital Robert Ballanger
🇫🇷Aulnay Sous Bois, Cedex, France
Ch De Fleyriat
🇫🇷Bourg En Bresse, Cedex, France
Hopital Augustin Morvan
🇫🇷Brest, Cedex, France
Ch De Brive La Gaillarde
🇫🇷Brive La Gaillarde, Cedex, France
Hopital Henri Mondor
🇫🇷Creteil, Cedex, France
CH De Bicetre
🇫🇷Le Kremlin Bicetre, Cedex, France
Institut J Paoli Calmettes
🇫🇷Marseille, Cedex, France
CHRU Lille - Hopital Huriez
🇫🇷Lille, Cedex, France
Hopital Saint Philibert
🇫🇷Lomme, Cedex, France
Hopital Edouard Herriot
🇫🇷Lyon, Cedex, France
Hopital N D Bon Secours
🇫🇷Metz, Cedex, France
Hopital Saint Antoine
🇫🇷Paris, Cedex, France
Clinique Pont de Chaume
🇫🇷Montauban, Cedex, France
Hopital Saint Jean
🇫🇷Perpignan, Cedex, France
Polyclinique Bordeaux Nord Aquitaine
🇫🇷Bordeaux, France
CHI Poissy Saint German en Laye
🇫🇷Poissy, Cedex, France
Chi De Cornouaille
🇫🇷Quimper, Cedex, France
Hopital De Haut Leveque
🇫🇷Pessac, Cedex, France
Hopital de La Maison Blanche
🇫🇷Reims, Cedex, France
Institut de Cancerologie de la Loire
🇫🇷Saint Priest En Jarez, Cedex, France
Hopital Font Pre
🇫🇷Toulon, Cedex, France
Ch De Vendome
🇫🇷Vendome, Cedex, France
Hopitaux de Brabois
🇫🇷Vandoeuvre Les Nancy, Cedex, France
Hopital Robert Boulin
🇫🇷Libourne, France
Cabinet D'Hematologie
🇫🇷Perpignan, France
CHU Nord - Chemin Des Bourrely
🇫🇷Marseille, France
CHRA
🇫🇷Metz Tessy, France
Centre De Radiotherapie
🇫🇷Strasbourg, France
CME
🇫🇷Brest, Cedex, France