Anagre Cap. in Patients With High-Risk Essential Thrombocythemia

Yuhan

Status and phase: Completed; Phase 4

Conditions: Essential Thrombocythemia

Treatments: Drug: Anagre Cap.

Study type: Interventional

Funder types: Industry

Identifiers

NCT03232177

YMC018

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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 (<less than 50 per minute)
  • History of clinically proven myocardial infarction and unstable angina within 3 months

• Pregnant women, nursing mothers

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

Anagre Cap.

Experimental group

Description:

twice a day

Treatment:

Drug: Anagre Cap.