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This study is to evaluate the efficacy and safety according to incremental dosing for 8 weeks and duration of administration for 1 year in patients with high-risk essential thrombocythemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anagre Cap. | Experimental | twice a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anagre Cap. | Drug | from 0.5mg twice a day to maximally increase total10mg in 8 weeks and maintain maximal tolerable dose to 104 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| response rate for less than 60 X 10^4/ul in platelet count | at week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| response rate for less than 60 X 10^4/ul in platelet count | at week 52 | |
| changes from baseline in 50% reduction rate in platelet count | up to 52 weeks | |
| response rate for less than 40 X 10^4/ul in platelet count |
| Measure | Description | Time Frame |
|---|---|---|
| expression of MPN-oncogene(JAK2/CALR/MPL) | association of known MPN-oncogene(JAK2/CALR/MPL) with epigenetic modifiers, mRNA splicing, oncogene and other minor somatic mutations | at 52 week |
| genomic biomarker search for prediction of side effects of anagrelide |
Inclusion Criteria:
Patients with essential thrombocythemia according to WHO 2008
Any of the following as high-risk patient
Exclusion Criteria:
Patients with an adverse drug reaction or intolerability to anagrelide
Any of the following cardiac abnormalities;
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Health Insurance Service Ilsan Hospital | Goyang-si | Gyeonggi-do | South Korea | |||
| The Catholic University of Korea. ST. Vincents Hospital |
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| up to 52 weeks |
| cumulative incidence of essential thrombocythemia related events (e.g thromboembolic or hemorrhagic events) | at 52 week |
| incidence of adverse events | up to 52 weeks |
| at 52 week |
| Suwon |
| Gyeonggi-do |
| South Korea |
| Hallym UNIV. Medical Center | Anyang | South Korea |
| Daegu Catholic University Medical Center | Daegu | South Korea |
| Keimyung University Dongsan Medical Center | Daegu | South Korea |
| Kyungpook national university hospital | Daegu | South Korea |
| Dongguk University Medical Center | Goyang | South Korea |
| Cheonnam National University Hwasun Hospital | Hwasun | South Korea |
| Gachon University Gil Medical Center | Incheon | South Korea |
| Inha University Hospital | Incheon | South Korea |
| Jeju National University Hospital | Jeju City | South Korea |
| Pusan National University Hospital | Pusan | South Korea |
| Ewha Wonans University Mokdong Hospital | Seoul | South Korea |
| Hallym UNIV. Medical Center | Seoul | South Korea |
| Inje University Sanggye Paik Hospital | Seoul | South Korea |
| Korea University Anam Hospital | Seoul | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| SMG - SNU Boramae Medical Center | Seoul | South Korea |
| Soon Chun Hyang University Hospital Seoul | Seoul | South Korea |
| Veterans Health Service medical Center | Seoul | South Korea |
| Yonsei University Health System, SEVERANCE HOSPITAL | Seoul | South Korea |
| ID | Term |
|---|---|
| D013920 | Thrombocythemia, Essential |
| ID | Term |
|---|---|
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D013922 | Thrombocytosis |
| D001791 | Blood Platelet Disorders |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006474 | Hemorrhagic Disorders |
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