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

• Register: ClinicalTrials.gov
• Last refreshed on: 18 February 2013
• Main ID: NCT01352585
• Date of registration: 10/05/2011
• Primary sponsor: Shire Development LLC
• Public title: Exploratory Multi-centre Trial In Patients With ET Treated With XAGRID® EMIX
• Scientific 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)
• Date of first enrolment: July 2011
• Target sample size: 60
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT01352585
• Study type: Observational
• Study design: Observational Model: Case-Only, Time Perspective: Prospective

Countries of recruitment

Italy

Contacts

• Name: Alessandro Vannucchi, MD
• Affiliation: Azienda Ospedaliero-Universitaria Careggi

Key inclusion & exclusion 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.



Age minimum: N/A
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Essential Thrombocythaemia

Intervention(s)

Drug: Anagrelide hydrochloride

Primary Outcome(s)

Number of patients with platelet count =600x10*9/L after 12 months [Time Frame: 1 year]

Secondary Outcome(s)

Differential WBC Count [Time Frame: 1 year]

Hematocrit Level [Time Frame: 1 year]

Hemoglobin concentration [Time Frame: 1 year]

Number of patients with platelet count =400x10*9/L after 12 months [Time Frame: 1 year]

Platelet Count [Time Frame: 1 year]

Red Blood Cell (RBC) Count [Time Frame: 1 year]

White Blood Cell (WBC) Count [Time Frame: 1 year]

Secondary ID(s)

SPD422-703

Source(s) of Monetary Support

Please refer to primary and secondary sponsors