A Multicenter, Open-label, Clinical Study for Efficacy and Safety Evaluation of Anagrelide in Patients With Treatment-naïve, High-risk Essential Thrombocythemia as a Primary Treatment
| Registry | NCT03232177 |
|---|---|
| Status | Completed |
| Phase | Phase 4 |
| Study type | Interventional; na, single group, masking: none, treatment |
| Enrollment | 70 (Actual) |
| Sponsor | Yuhan Corporation (Industry) |
| Conditions | Essential Thrombocythemia |
| Interventions | Anagre Cap. (Drug) |
| Dates | start 2017-06-05, primary completion 2020-12-05, completion 2020-12-05, first posted 2017-07-27, last updated 2021-07-21 |
| Locations | 21 sites in South Korea |
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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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Anagre Cap. | Experimental | Drug: Anagre Cap. | twice a day |
Sex: All, ages: 19 Years to any
Inclusion Criteria: * Patients with essential thrombocythemia according to WHO 2008 * Any of the following as high-risk patient * Over 60 years old * >100 X 10\^4/ul of platelet count * increased more than 300K of platelet count in 3 months * Hypertension, diabetes, past history of thromboembolic bleeding Exclusion Criteria: * Patients with an adverse drug reaction or intolerability to anagrelide * Any of the following cardiac abnormalities; * Complete left bundle branch block on ECG * Patients using a pacemaker * Patients with a family history of congenital QT prolongation syndrome or known QT prolongation syndrome * Currently, there is no clinically uncontrolled ventricular or atrial tachycardia * Clinically significant bradycardia (<less than 50 per minute) * History of clinically proven myocardial infarction and unstable angina within 3 months * Pregnant women, nursing mothers
| Facility | City | Country | Status |
|---|---|---|---|
| National Health Insurance Service Ilsan Hospital | Goyang-si, Gyeonggi-do | South Korea | |
| The Catholic University of Korea. ST. Vincents Hospital | 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 |