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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	21 June 2021
Main ID:	NCT01192347
Date of registration:	26/08/2010
Prospective Registration:	Yes
Primary sponsor:	Shire
Public title:	French Observational Xagrid (FOX) Study In Adult Patients With Essential Thrombocythemia FOX
Scientific title:	A Phase 4, 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
Date of first enrolment:	September 13, 2010
Target sample size:	177
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT01192347
Study type:	Observational
Study design:
Phase:

Countries of recruitment
France

Contacts

Name:	Study Director
Address:
Telephone:
Email:
Affiliation:	Takeda

Key inclusion & exclusion criteria

Inclusion Criteria

1. Patients aged 18 years and older.

2. High-risk ET Patients, uncontrolled by first-line (or previous) cytoreductive
treatment for efficacy or tolerance reasons.

3. 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.

4. 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

1. Patients with a known or suspected intolerance or hypersensitivity to XAGRID, closely
related compounds, or any of the stated ingredients.

2. Patients for whom there is an intention to treat with combinations of cytoreductive
therapy.

3. Patients participating in a separate clinical trial where their treatment is defined
by that study protocol.

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Essential Thrombocythemia

Intervention(s)

Primary Outcome(s)

Percentage of Subjects Achieving Platelet Target Response: Withdrawal of Previous Cytoreductive Therapy After Anagrelide Hydrochloride Initiation [Time Frame: 6 months]

Percentage of Subjects Achieving Platelet Target Response: When the Dosing Was Consistent With the Summary of Product Characteristics (SmPC) [Time Frame: 6 months]

Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: When the Dosing Was Consistent With the Summary of Product Characteristics (SmPC) [Time Frame: 6 months]

Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: Withdrawal of Previous Cytoreductive Therapy After Anagrelide Hydrochloride Initiation [Time Frame: 6 months]

Percentage of Subjects Achieving Platelet Target Response: Withdrawal of Previous Cytoreductive Therapy Before Anagrelide Hydrochloride Initiation [Time Frame: 6 months]

Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: When the Dosing Was Inconsistent With the Summary of Product Characteristics (SmPC) [Time Frame: 6 months]

Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: Withdrawal of Previous Cytoreductive Therapy Before Anagrelide Hydrochloride Initiation [Time Frame: 6 months]

Percentage of Subjects Achieving Platelet Target Response: No Withdrawal of Previous Cytoreductive Therapy [Time Frame: 6 months]

Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: No Withdrawal of Previous Cytoreductive Therapy [Time Frame: 6 months]

Percentage of Subjects Achieving Platelet Target Response: When the Dosing Was Inconsistent With the Summary of Product Characteristics (SmPC) [Time Frame: 6 months]

Secondary Outcome(s)

Summary of Adverse Drug Reactions: When the Dosing Was Inconsistent With the Summary of Product Characteristics (SmPC) [Time Frame: 6 months]

Summary of Adverse Drug Reactions: When the Dosing Was Consistent With the Summary of Product Characteristics (SmPC) [Time Frame: 6 months]

Maximum Daily Dose of Anagrelide Hydrochloride [Time Frame: 6 months]

Summary of Adverse Drug Reactions: No Withdrawal of Previous Cytoreductive Therapy [Time Frame: 6 months]

Summary of Adverse Drug Reactions (ADR): Withdrawal of Previous Cytoreductive Therapy Before Anagrelide Hydrochloride Initiation [Time Frame: 6 months]

Summary of Adverse Drug Reactions: Withdrawal of Previous Cytoreductive Therapy After Anagrelide Hydrochloride Initiation [Time Frame: 6 months]

Number of Subjects With Anagrelide Hydrochloride Titration Modifcations- First Modification Only [Time Frame: 6 months]

Percentage of Subjects With Anagrelide Hydrochloride Starting Doses [Time Frame: 6 months]

Secondary ID(s)

SPD422-702

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:	Yes
Date Posted:	25/09/2013
Date Completed:
URL:	https://clinicaltrials.gov/ct2/show/results/NCT01192347

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