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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03232177

Enrollment

Registered

2017-07-27

Start date

2017-06-05

Completion date

2020-12-05

Last updated

2021-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Essential Thrombocythemia

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.

Interventions

DRUGAnagre Cap.

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Measure	Time frame	Description
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	—

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026