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Completed

NCT Number: NCT01352585

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

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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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda Ospedaliera Policlinico di Bari, Bari, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Anagrelide hydrochloride

Drug

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

Other names: Xagrid

Primary outcomes

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

    Time frame: 1 year

    A platelet count of ≤600x10^9/L after 12 months is considered at least a partial response.

Secondary outcomes

  1. Number of Patients With Platelet Count ≤400x10^9/L After 12 Months

    Time frame: 1 year

    A platelet count of ≤400x10^9/L after 12 months is considered a complete response.

  2. Platelet Count

    Time frame: 1 year

  3. Red Blood Cell (RBC) Count

    Time frame: 1 year

  4. White Blood Cell (WBC) Count

    Time frame: 1 year

  5. Differential WBC Count - Neutrophils, Lymphocytes, Monocytes, and Basophils.

    Time frame: 1 year

  6. Differential WBC Count - Eosinophils

    Time frame: 1 year

  7. Hemoglobin Concentration

    Time frame: 1 year

  8. Hematocrit Level

    Time frame: 1 year

    The proportion of the volume of red blood cells to the total volume of blood.

Sponsors and collaborators

Lead sponsor

Shire

Industry

Registry information

Official study title

An Exploratory, Observational, Multicentre Study to Investigate the Impact of the Presence of JAK2 (V617F) Mutation on Treatment Response in Patients With Essential Thrombocythaemia Treated With XAGRID® (Anagrelide Hydrochloride)

Acronym: EMIX

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
May 12, 2011
Registry last updated
Jul 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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