CompletedNot Applicable

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

Italy47 participantsStarted 2011-07-19

Plain-language summary

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

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Patients With Platelet Count ≤600x10^9/L After 12 Months

Timeframe: 1 year

Trial details

NCT IDNCT01352585

SponsorShire

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2013-09-19

Results submitted2014-06-27

View on ClinicalTrials.gov More Essential Thrombocythemia (ET) trials

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.