Essential Thrombocythemia (ET)EMIXNCT01352585
Exploratory Multi-centre Trial In Patients With ET Treated With XAGRID®
An observational study of Essential Thrombocythemia (ET), run by Shire at 10 sites in Italy.
Trial summary
This study is hypothesis-generating to explore the impact of JAK2 (V617F) mutation status on the treatment response to anagrelide hydrochloride Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Essential Thrombocythemia (ET)
- What is being tested?
- Anagrelide hydrochloride
- Type of treatment
- Pill or oral medicine
- How many people
- 47 participants
- Where
- 10 sitesItaly
- Study dates
- 19 Jul 2011to 19 Sep 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: ET patients in Italy
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Italy10 sites
Azienda Ospedaliera Policlinico di Bari
Bari
Istituto Seragnoli-Policlinico S.Orsola-Malpighi
Bologna
A.O. Spedali Civili di Brescia
Brescia
Azienda Ospedaliero-Universitaria Careggi
Florence
Ospedale San Martino
Genova
Fondazione IRCCS Ca' Granda
Milan, 20125
Azienda Ospedaliera Universitaria "Federico II"
Naples, 80131
Ospedale Maggiore della Carita
Novara
Policlinico A. Gemelli
Roma
Padiglione ex-oncologico Ospedale S.Maria
Terni
About this study
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)
This study is hypothesis-generating to explore the impact of JAK2 (V617F) mutation status on the treatment response to anagrelide hydrochloride
- Conditions
- Essential Thrombocythemia (ET)
- Being tested
- Anagrelide hydrochloride
- Medical subject headings
- Thrombocythemia, Essential
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anagrelide hydrochlorideDrug
Also called Xagrid
0.5 mg hard capsules, dosing decisions will be made by the treating physician
| Study group | Role | What they receive |
|---|---|---|
| JAK2 Positive Participants | Not described Receives: Drug: Anagrelide hydrochloride | |
| JAK2 Negative Participants | Not described Receives: Drug: Anagrelide hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Platelet Count ≤600x10^9/L After 12 Months
A platelet count of ≤600x10^9/L after 12 months is considered at least a partial response.
Measured: 1 year
Secondary outcomes (8)
Number of Patients With Platelet Count ≤400x10^9/L After 12 Months
A platelet count of ≤400x10^9/L after 12 months is considered a complete response.
Measured: 1 year
Platelet Count
Measured: 1 year
Red Blood Cell (RBC) Count
Measured: 1 year
White Blood Cell (WBC) Count
Measured: 1 year
Differential WBC Count - Neutrophils, Lymphocytes, Monocytes, and Basophils.
Measured: 1 year
Differential WBC Count - Eosinophils
Measured: 1 year
Hemoglobin Concentration
Measured: 1 year
Hematocrit Level
The proportion of the volume of red blood cells to the total volume of blood.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2011 (estimated)
- Study start19 Jul 2011
- Primary completion19 Sep 2013
- Study completion19 Sep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Essential Thrombocythemia (ET)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01352585
- Sponsor's protocol ID
- SPD422-703
- Acronym
- EMIX
- Status last verified
- Jul 2021
- First submitted
- 10 May 2011
- Last updated
- 30 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Cascavilla N, De Stefano V, Pane F, Pancrazzi A, Iurlo A, Gobbi M, Palandri F, Specchia G, Liberati AM, D'Adda M, Gaidano G, Fjerza R, Achenbach H, Smith J, Wilde P, Vannucchi AM. Impact of JAK2(V617F) mutation status on treatment response to anagrelide in essential thrombocythemia: an observational, hypothesis-generating study. Drug Des Devel Ther. 2015 May 18;9:2687-94. doi: 10.2147/DDDT.S79576. eCollection 2015.
PubMed 26028965
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01352585
- Acronym / sponsor ID
- EMIX / SPD422-703
- Conditions
- Essential Thrombocythemia (ET)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 19 Jul 2011 (actual)
- Primary completion
- 19 Sep 2013 (actual)
- Study completion
- 19 Sep 2013 (actual)
- First posted
- 12 May 2011 (estimated)
- Results
- Posted 29 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is hypothesis-generating to explore the impact of JAK2 (V617F) mutation status on the treatment response to anagrelide hydrochloride
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JAK2 Positive Participants | – | Drug: Anagrelide hydrochloride |
| JAK2 Negative Participants | – | Drug: Anagrelide hydrochloride |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- ET patients in Italy
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anagrelide hydrochlorideAlso: Xagrid0.5 mg hard capsules, dosing decisions will be made by the treating physician | Drug | JAK2 Negative Participants, JAK2 Positive Participants |
Primary outcome
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.
8 secondary outcomes
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
Differential WBC Count - Neutrophils, Lymphocytes, Monocytes, and Basophils.
Time frame: 1 year
Differential WBC Count - Eosinophils
Time frame: 1 year
Hemoglobin Concentration
Time frame: 1 year
Hematocrit Level
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26028965Cascavilla N, De Stefano V, Pane F, Pancrazzi A, Iurlo A, Gobbi M, Palandri F, Specchia G, Liberati AM, D'Adda M, Gaidano G, Fjerza R, Achenbach H, Smith J, Wilde P, Vannucchi AM. Impact of JAK2(V617F) mutation status on treatment response to anagrelide in essential thrombocythemia: an observational, hypothesis-generating study. Drug Des Devel Ther. 2015 May 18;9:2687-94. doi: 10.2147/DDDT.S79576. eCollection 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Essential Thrombocythemia (ET), run by Shire at 10 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Platelet Count ≤600x10^9/L After 12 Months (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01352585, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2021; AzTrials last refreshed its copy on 30 Oct 2026.