Exploratory Multi-centre Trial In Patients With ET Treated With XAGRID® (EMIX)
This study is ongoing, but not recruiting participants.
Sponsor:
Shire Development LLC
Information provided by (Responsible Party):
Shire Development LLC
ClinicalTrials.gov Identifier:
NCT01352585
First received: May 10, 2011
Last updated: February 14, 2013
Last verified: February 2013
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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 Development LLC:
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 ]
| Estimated Enrollment: | 60 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 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:
- 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.
Contacts and Locations
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 Development LLC
Investigators
| Principal Investigator: | Alessandro Vannucchi, MD | Azienda Ospedaliero-Universitaria Careggi |
More Information
No publications provided
| Responsible Party: | Shire Development LLC |
| ClinicalTrials.gov Identifier: | NCT01352585 History of Changes |
| Other Study ID Numbers: | SPD422-703 |
| Study First Received: | May 10, 2011 |
| Last Updated: | February 14, 2013 |
| 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 May 21, 2013