Skip to main content
OpenTrials
Completed

NCT Number: NCT03232177

Anagre Cap. in Patients With High-Risk Essential Thrombocythemia

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Essential Thrombocythemia Blood Coagulation Disorders Blood Platelet Disorders Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Myeloproliferative Disorders Thrombocythemia, Essential Thrombocytosis

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

National Health Insurance Service Ilsan Hospital, Goyang-si, Gyeonggi-do, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anagre Cap.

Drug

from 0.5mg twice a day to maximally increase total10mg in 8 weeks and maintain maximal tolerable dose to 104 weeks

Primary outcomes

  1. response rate for less than 60 X 10^4/ul in platelet count

    Time frame: at week 8

Secondary outcomes

  1. response rate for less than 60 X 10^4/ul in platelet count

    Time frame: at week 52

  2. changes from baseline in 50% reduction rate in platelet count

    Time frame: up to 52 weeks

  3. response rate for less than 40 X 10^4/ul in platelet count

    Time frame: up to 52 weeks

  4. cumulative incidence of essential thrombocythemia related events (e.g thromboembolic or hemorrhagic events)

    Time frame: at 52 week

  5. incidence of adverse events

    Time frame: up to 52 weeks

Other outcomes

  1. expression of MPN-oncogene(JAK2/CALR/MPL)

    Time frame: at 52 week

    association of known MPN-oncogene(JAK2/CALR/MPL) with epigenetic modifiers, mRNA splicing, oncogene and other minor somatic mutations

  2. genomic biomarker search for prediction of side effects of anagrelide

    Time frame: at 52 week

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jul 27, 2017
Registry last updated
Jul 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.