Anagre Cap. in Patients With High-Risk Essential Thrombocythemia

• Status: Completed
• Trial end date: 2020-12-05
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yuhan Corporation

Criteria

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 (- History of clinically proven myocardial infarction and unstable angina within 3 months

• Pregnant women, nursing mothers