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This study is hypothesis-generating to explore the impact of JAK2 (V617F) mutation status on the treatment response to anagrelide hydrochloride
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JAK2 Positive Participants |
| ||
| JAK2 Negative Participants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anagrelide hydrochloride | Drug | 0.5 mg hard capsules, dosing decisions will be made by the treating physician |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
| Platelet Count | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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ET patients in Italy
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliera Policlinico di Bari | Bari | Italy | ||||
| Istituto Seragnoli-Policlinico S.Orsola-Malpighi |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26028965 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | JAK2 Positive Participants | Anagrelide hydrochloride: 0.5 mg hard capsules, dosing decisions will be made by the treating physician |
| FG001 | JAK2 Negative Participants | Anagrelide hydrochloride: 0.5 mg hard capsules, dosing decisions will be made by the treating physician |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | JAK2 Positive Participants | Anagrelide hydrochloride: 0.5 mg hard capsules, dosing decisions will be made by the treating physician |
| BG001 | JAK2 Negative Participants | Anagrelide hydrochloride: 0.5 mg hard capsules, dosing decisions will be made by the treating physician |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The Full Analysis Set (FAS) in each JAK2 status group who had a viable platelet sample during the 12-month follow-up window. For this Outcome Measure 35 patients in the FAS had a viable laboratory sample. | Posted | Number | participants | 1 year |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | JAK2 Positive Participants | Anagrelide hydrochloride: 0.5 mg hard capsules, dosing decisions will be made by the treating physician |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| anemia | Blood and lymphatic system disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Shire | +1 866 842 5335 | ClinicalTransparency@shire.com |
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| ID | Term |
|---|---|
| D013920 | Thrombocythemia, Essential |
| ID | Term |
|---|---|
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D013922 | Thrombocytosis |
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| ID | Term |
|---|---|
| C021139 | anagrelide |
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|
| Red Blood Cell (RBC) Count | 1 year |
| White Blood Cell (WBC) Count | 1 year |
| Differential WBC Count - Neutrophils, Lymphocytes, Monocytes, and Basophils. | 1 year |
| Differential WBC Count - Eosinophils | 1 year |
| Hemoglobin Concentration | 1 year |
| Hematocrit Level | The proportion of the volume of red blood cells to the total volume of blood. | 1 year |
| Bologna |
| Italy |
| A.O. Spedali Civili di Brescia | Brescia | Italy |
| Azienda Ospedaliero-Universitaria Careggi | Florence | Italy |
| Ospedale San Martino | Genova | Italy |
| Fondazione IRCCS Ca' Granda | Milan | 20125 | Italy |
| Azienda Ospedaliera Universitaria "Federico II" | Naples | 80131 | Italy |
| Ospedale Maggiore della Carita | Novara | Italy |
| Policlinico A. Gemelli | Roma | Italy |
| Padiglione ex-oncologico Ospedale S.Maria | Terni | Italy |
| Other |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Secondary | 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. | The Full Analysis Set (FAS) in each JAK2 status group who had a viable platelet sample during the 12-month follow-up window. For this Outcome Measure 35 patients in the FAS had a viable laboratory sample. | Posted | Number | participants | 1 year |
|
|
|
| Secondary | Platelet Count | The Full Analysis Set (FAS) in each JAK2 status group who had a viable platelet sample during the 12-month follow-up window. For this Outcome Measure 28 patients in the FAS had a viable laboratory sample. | Posted | Mean | Standard Deviation | Platelets (x10^9/L) | 1 year |
|
|
|
| Secondary | Red Blood Cell (RBC) Count | The Safety Analysis Set (SAS) consisted of all subjects enrolled in the study who took at least 1 dose of anagrelide hydrochloride. 27 patients in the SAS met this requirement and had a viable laboratory sample. | Posted | Mean | Standard Deviation | RBC Count (x10^12/L) | 1 year |
|
|
|
| Secondary | White Blood Cell (WBC) Count | The Full Analysis Set (FAS) in each JAK2 status group who had a viable platelet sample during the 12-month follow-up window. For this Outcome Measure 28 patients in the FAS had a viable laboratory sample. | Posted | Mean | Standard Deviation | WBC Count (x10^9/L) | 1 year |
|
|
|
| Secondary | Differential WBC Count - Neutrophils, Lymphocytes, Monocytes, and Basophils. | The Full Analysis Set (FAS) in each JAK2 status group who had a viable platelet sample during the 12-month follow-up window. For this Outcome Measure 28 patients in the FAS had a viable laboratory sample. | Posted | Mean | Standard Deviation | percent | 1 year |
|
|
|
| Secondary | Differential WBC Count - Eosinophils | The Full Analysis Set (FAS) in each JAK2 status group who had a viable platelet sample during the 12-month follow-up window. For this Outcome Measure 27 patients in the FAS had a viable laboratory sample. | Posted | Mean | Standard Deviation | percent | 1 year |
|
|
|
| Secondary | Hemoglobin Concentration | The Safety Analysis Set (SAS) consisted of all subjects enrolled in the study who took at least 1 dose of anagrelide hydrochloride. 28 patients in the SAS had a viable laboratory sample. | Posted | Mean | Standard Deviation | g/L | 1 year |
|
|
|
| Secondary | Hematocrit Level | The proportion of the volume of red blood cells to the total volume of blood. | The Safety Analysis Set (SAS) consisted of all subjects enrolled in the study who took at least 1 dose of anagrelide hydrochloride. 27 patients in the SAS had a viable laboratory sample. | Posted | Mean | Standard Deviation | Hematocrit (fraction of 1) | 1 year |
|
|
|
| 0 |
| 23 |
| 6 |
| 23 |
| EG001 | JAK2 Negative Participants | Anagrelide hydrochloride: 0.5 mg hard capsules, dosing decisions will be made by the treating physician | 0 | 24 | 9 | 24 |
| Palpitations | Cardiac disorders |
|
| Tachycardia | Cardiac disorders |
|
| Scotoma | Eye disorders |
|
| Diarrhea | Gastrointestinal disorders |
|
| Hyperuricemia | Metabolism and nutrition disorders |
|
| Headache | Nervous system disorders |
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| Presyncope | Nervous system disorders |
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| Dermatits | Skin and subcutaneous tissue disorders |
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| Pruritus | Skin and subcutaneous tissue disorders |
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If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
| D001791 | Blood Platelet Disorders |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006474 | Hemorrhagic Disorders |
| Monocytes |
|
| Basophils |
|