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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01352585
Recruitment Status : Completed
First Posted : May 12, 2011
Results First Posted : July 29, 2014
Last Update Posted : July 29, 2014
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Essential Thrombocythaemia Drug: Anagrelide hydrochloride

Study Type : Observational
Actual Enrollment : 47 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official 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)
Study Start Date : July 2011
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Group/Cohort Intervention/treatment
Anagrelide hydrochloride Drug: Anagrelide hydrochloride
0.5 mg hard capsules, dosing decisions will be made by the treating physician
Other Name: Xagrid

Primary Outcome Measures :
  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 Outcome Measures :
  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 [ Time Frame: 1 year ]
  6. Hemoglobin Concentration [ Time Frame: 1 year ]
  7. Hematocrit Level [ Time Frame: 1 year ]

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
ET patients in Italy

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01352585

Azienda Ospedaliera Policlinico di Bari
Bari, Italy
Istituto Seragnoli-Policlinico S.Orsola-Malpighi
Bologna, Italy
A.O. Spedali Civili di Brescia
Brescia, Italy
Azienda Ospedaliero-Universitaria Careggi
Firenze, Italy
Ospedale San Martino
Genova, Italy
Fondazione IRCCS Ca' Granda
Milan, Italy, 20125
Azienda Ospedaliera Universitaria "Federico II"
Napoli, Italy, 80131
Ospedale Maggiore della Carita
Novara, Italy
Policlinico A. Gemelli
Roma, Italy
Padiglione ex-oncologico Ospedale S.Maria
Terni, Italy
Sponsors and Collaborators
Principal Investigator: Alessandro Vannucchi, MD Azienda Ospedaliero-Universitaria Careggi

Responsible Party: Shire Identifier: NCT01352585     History of Changes
Other Study ID Numbers: SPD422-703
First Posted: May 12, 2011    Key Record Dates
Results First Posted: July 29, 2014
Last Update Posted: July 29, 2014
Last Verified: June 2014

Additional relevant MeSH terms:
Thrombocythemia, Essential
Blood Platelet Disorders
Hematologic Diseases
Myeloproliferative Disorders
Bone Marrow Diseases
Blood Coagulation Disorders
Hemorrhagic Disorders
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors