Exploratory Multi-centre Trial In Patients With ET Treated With XAGRID®

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

47 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-19

Study Completion Date

2013-09-19

Brief Summary

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This study is hypothesis-generating to explore the impact of JAK2 (V617F) mutation status on the treatment response to anagrelide hydrochloride

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Detailed Description

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Conditions

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Essential Thrombocythemia (ET)

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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JAK2 Positive Participants

Anagrelide hydrochloride

Intervention Type DRUG

0.5 mg hard capsules, dosing decisions will be made by the treating physician

JAK2 Negative Participants

Anagrelide hydrochloride

Intervention Type DRUG

0.5 mg hard capsules, dosing decisions will be made by the treating physician

Interventions

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Anagrelide hydrochloride

0.5 mg hard capsules, dosing decisions will be made by the treating physician

Intervention Type DRUG

Other Intervention Names

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Xagrid

Eligibility Criteria

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Inclusion Criteria

1. Patients must be able to understand and willing to participate in the study, and provide a personally dated and signed written informed consent form.
2. Patients must have a confirmed diagnosis of ET according to the World health Organisation's criteria.
3. ET patients who are uncontrolled, in the Investigator's opinion, by first-line (or previous) cytoreductive treatment for efficacy or tolerance reasons.
4. 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

1. Patients for whom treatment with anagrelide hydrochloride is contraindicated, according to the current XAGRID SmPC.
2. Known or suspected intolerance or hypersensitivity to the product, closely related compounds, or any of the stated ingredients.
3. Patients participating in an interventional research study.
4. 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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No