Anagre Cap. in Patients With High-Risk Essential Thrombocythemia
- Conditions
- Essential Thrombocythemia
- Interventions
- Drug: Anagre Cap.
- Registration Number
- NCT03232177
- Lead Sponsor
- Yuhan Corporation
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
-
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
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Anagre Cap. Anagre Cap. twice a day
- Primary Outcome Measures
Name Time Method response rate for less than 60 X 10^4/ul in platelet count at week 8
- Secondary Outcome Measures
Name Time Method incidence of adverse events up to 52 weeks 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 up to 52 weeks cumulative incidence of essential thrombocythemia related events (e.g thromboembolic or hemorrhagic events) at 52 week
Trial Locations
- Locations (20)
National Health Insurance Service Ilsan Hospital
🇰🇷Goyang, Gyeonggi, Korea, Republic of
The Catholic University of Korea. ST. Vincents Hospital
🇰🇷Suwon-si, Gyeonggi, Korea, Republic of
Hallym UNIV. Medical Center
🇰🇷Seoul, Korea, Republic of
Daegu Catholic University Medical Center
🇰🇷Daegu, Korea, Republic of
Keimyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Kyungpook national university hospital
🇰🇷Daegu, Korea, Republic of
Dongguk University Medical Center
🇰🇷Goyang, Korea, Republic of
Cheonnam National University Hwasun Hospital
🇰🇷Hwasun, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Inha University Hospital
🇰🇷Incheon, Korea, Republic of
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