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 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 incidence of adverse events up to 52 weeks
Trial Locations
- Locations (20)
Veterans Health Service medical Center
🇰🇷Seoul, Korea, Republic of
Dongguk University Medical Center
🇰🇷Goyang, 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
Jeju National University Hospital
🇰🇷Jeju City, Korea, Republic of
Ewha Wonans University Mokdong Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Yonsei University Health System, SEVERANCE HOSPITAL
🇰🇷Seoul, Korea, Republic of
Cheonnam National University Hwasun Hospital
🇰🇷Hwasun, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Inje University Sanggye Paik Hospital
🇰🇷Seoul, Korea, Republic of
National Health Insurance Service Ilsan Hospital
🇰🇷Goyang, Gyeonggi, Korea, Republic of
Kyungpook national university hospital
🇰🇷Daegu, Korea, Republic of
Keimyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Inha University Hospital
🇰🇷Incheon, Korea, Republic of
Pusan National University Hospital
🇰🇷Pusan, Korea, Republic of
Soon Chun Hyang University Hospital Seoul
🇰🇷Seoul, Korea, Republic of
SMG - SNU Boramae Medical Center
🇰🇷Seoul, Korea, Republic of