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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01352585
First received: May 10, 2011
Last updated: January 29, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention
Essential Thrombocythaemia
Drug: Anagrelide hydrochloride

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • Number of patients with platelet count ≤600x10*9/L after 12 months [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of patients with platelet count ≤400x10*9/L after 12 months [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Platelet Count [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Red Blood Cell (RBC) Count [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • White Blood Cell (WBC) Count [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Differential WBC Count [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Hemoglobin concentration [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Hematocrit Level [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 47
Study Start Date: July 2011
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Anagrelide hydrochloride Drug: Anagrelide hydrochloride
0.5 mg hard capsules, dosing decisions will be made by the treating physician
Other Name: Xagrid

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

ET patients in Italy

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01352585

Locations
Italy
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
Shire
Investigators
Principal Investigator: Alessandro Vannucchi, MD Azienda Ospedaliero-Universitaria Careggi
  More Information

No publications provided

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01352585     History of Changes
Other Study ID Numbers: SPD422-703
Study First Received: May 10, 2011
Last Updated: January 29, 2014
Health Authority: Italy: Ethics Committee

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

ClinicalTrials.gov processed this record on July 24, 2014