Status:
COMPLETED
Anagre Cap. in Patients With High-Risk Essential Thrombocythemia
Lead Sponsor:
Yuhan Corporation
Conditions:
Essential Thrombocythemia
Eligibility:
All Genders
19+ years
Phase:
PHASE4
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 5 2020
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT03232177
Start Date
June 5 2017
End Date
December 5 2020
Last Update
July 21 2021
Active Locations (21)
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1
National Health Insurance Service Ilsan Hospital
Goyang-si, Gyeonggi-do, South Korea
2
The Catholic University of Korea. ST. Vincents Hospital
Suwon, Gyeonggi-do, South Korea
3
Hallym UNIV. Medical Center
Anyang, South Korea
4
Daegu Catholic University Medical Center
Daegu, South Korea