Anagre Cap. in Patients With High-Risk Essential Thrombocythemia
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Anagre Cap. twice a day |
Drug: Anagre Cap.
from 0.5mg twice a day to maximally increase total10mg in 8 weeks and maintain maximal tolerable dose to 104 weeks
|
Outcome Measures
Primary Outcome Measures
- response rate for less than 60 X 10^4/ul in platelet count [at week 8]
Secondary Outcome Measures
- 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]
Other Outcome Measures
- expression of MPN-oncogene(JAK2/CALR/MPL) [at 52 week]
association of known MPN-oncogene(JAK2/CALR/MPL) with epigenetic modifiers, mRNA splicing, oncogene and other minor somatic mutations
- genomic biomarker search for prediction of side effects of anagrelide [at 52 week]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients with essential thrombocythemia according to WHO 2008
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Any of the following as high-risk patient
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Over 60 years old
-
100 X 10^4/ul of platelet count
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increased more than 300K of platelet count in 3 months
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Hypertension, diabetes, past history of thromboembolic bleeding
Exclusion Criteria:
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Patients with an adverse drug reaction or intolerability to anagrelide
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Any of the following cardiac abnormalities;
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Complete left bundle branch block on ECG
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Patients using a pacemaker
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Patients with a family history of congenital QT prolongation syndrome or known QT prolongation syndrome
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Currently, there is no clinically uncontrolled ventricular or atrial tachycardia
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Clinically significant bradycardia (<less than 50 per minute)
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History of clinically proven myocardial infarction and unstable angina within 3 months
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Pregnant women, nursing mothers
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | National Health Insurance Service Ilsan Hospital | Goyang | Gyeonggi | Korea, Republic of | |
2 | The Catholic University of Korea. ST. Vincents Hospital | Suwon-si | Gyeonggi | Korea, Republic of | |
3 | Hallym UNIV. Medical Center | Anyang | Korea, Republic of | ||
4 | Daegu Catholic University Medical Center | Daegu | Korea, Republic of | ||
5 | Keimyung University Dongsan Medical Center | Daegu | Korea, Republic of | ||
6 | Kyungpook national university hospital | Daegu | Korea, Republic of | ||
7 | Dongguk University Medical Center | Goyang | Korea, Republic of | ||
8 | Cheonnam National University Hwasun Hospital | Hwasun | Korea, Republic of | ||
9 | Gachon University Gil Medical Center | Incheon | Korea, Republic of | ||
10 | Inha University Hospital | Incheon | Korea, Republic of | ||
11 | Jeju National University Hospital | Jeju City | Korea, Republic of | ||
12 | Pusan National University Hospital | Pusan | Korea, Republic of | ||
13 | Ewha Wonans University Mokdong Hospital | Seoul | Korea, Republic of | ||
14 | Hallym UNIV. Medical Center | Seoul | Korea, Republic of | ||
15 | Inje University Sanggye Paik Hospital | Seoul | Korea, Republic of | ||
16 | Korea University Anam Hospital | Seoul | Korea, Republic of | ||
17 | Seoul National University Hospital | Seoul | Korea, Republic of | ||
18 | SMG - SNU Boramae Medical Center | Seoul | Korea, Republic of | ||
19 | Soon Chun Hyang University Hospital Seoul | Seoul | Korea, Republic of | ||
20 | Veterans Health Service medical Center | Seoul | Korea, Republic of | ||
21 | Yonsei University Health System, SEVERANCE HOSPITAL | Seoul | Korea, Republic of |
Sponsors and Collaborators
- Yuhan Corporation
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- YMC018