Anagre Cap. in Patients With High-Risk Essential Thrombocythemia

A Multicenter, Open-label, Clinical Study for Efficacy and Safety Evaluation of Anagrelide in Patients With Treatment-naïve, High-risk Essential Thrombocythemia as a Primary Treatment

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.

Study Overview

• Status: Completed
• Conditions: Essential Thrombocythemia
• Intervention / Treatment: Drug: Anagre Cap.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Anyang, Korea, Republic of
    • Hallym Univ. Medical Center
  • Daegu, 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
  • Goyang, Korea, Republic of
    • Dongguk University Medical Center
  • Hwasun, Korea, Republic of
    • Cheonnam National University Hwasun Hospital
  • Incheon, Korea, Republic of
    • Inha University Hospital
  • Incheon, Korea, Republic of
    • Gachon University Gil Medical Center
  • Jeju City, Korea, Republic of
    • Jeju National University Hospital
  • Pusan, Korea, Republic of
    • Pusan National University Hospital
  • Seoul, Korea, Republic of
    • Seoul National University Hospital
  • Seoul, Korea, Republic of
    • Yonsei University Health system, Severance Hospital
  • Seoul, Korea, Republic of
    • Korea University Anam Hospital
  • Seoul, Korea, Republic of
    • Soon Chun Hyang University Hospital Seoul
  • Seoul, Korea, Republic of
    • Inje University Sanggye Paik Hospital
  • Seoul, Korea, Republic of
    • Ewha Wonans University Mokdong Hospital
  • Seoul, Korea, Republic of
    • Hallym Univ. Medical Center
  • Seoul, Korea, Republic of
    • SMG - SNU Boramae Medical Center
  • Seoul, Korea, Republic of
    • Veterans Health Service Medical Center
  • Gyeonggi
    • Goyang, Gyeonggi, Korea, Republic of
      • National Health Insurance Service Ilsan Hospital
    • Suwon-si, Gyeonggi, Korea, Republic of
      • The Catholic University of Korea. ST. Vincents Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
response rate for less than 60 X 10^4/ul in platelet count	at week 8

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
expression of MPN-oncogene(JAK2/CALR/MPL)	association of known MPN-oncogene(JAK2/CALR/MPL) with epigenetic modifiers, mRNA splicing, oncogene and other minor somatic mutations	at 52 week
genomic biomarker search for prediction of side effects of anagrelide		at 52 week

Collaborators and Investigators

• Sponsor: Yuhan Corporation

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 5, 2017
• Primary Completion (ACTUAL): December 5, 2020
• Study Completion (ACTUAL): December 5, 2020

Study Registration Dates

• First Submitted: July 11, 2017
• First Submitted That Met QC Criteria: July 24, 2017
• First Posted (ACTUAL): July 27, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 21, 2021
• Last Update Submitted That Met QC Criteria: July 20, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Marrow Diseases; Hematologic Diseases; Hemorrhagic Disorders; Myeloproliferative Disorders; Blood Coagulation Disorders; Blood Platelet Disorders; Thrombocytosis; Thrombocythemia, Essential
• Other Study ID Numbers: YMC018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No