Anagre Cap. in Patients With High-Risk Essential Thrombocythemia

Essential Thrombocythemia Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03232177
• Other study ID #: YMC018
• Status: Completed
• Phase: Phase 4
• Start date: June 5, 2017
• Est. completion date: December 5, 2020

Study information

• Verified date: July 2021
• Source: Yuhan Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 5, 2020
• Est. primary completion date: December 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Essential Thrombocythemia
• Thrombocythemia, Essential
• Thrombocytosis

Intervention

Drug:
• Anagre Cap.
from 0.5mg twice a day to maximally increase total10mg in 8 weeks and maintain maximal tolerable dose to 104 weeks

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Yuhan Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	genomic biomarker search for prediction of side effects of anagrelide		at 52 week
Primary	response rate for less than 60 X 10^4/ul in platelet count		at week 8
Secondary	response rate for less than 60 X 10^4/ul in platelet count		at week 52
Secondary	changes from baseline in 50% reduction rate in platelet count		up to 52 weeks
Secondary	response rate for less than 40 X 10^4/ul in platelet count		up to 52 weeks
Secondary	cumulative incidence of essential thrombocythemia related events (e.g thromboembolic or hemorrhagic events)		at 52 week
Secondary	incidence of adverse events		up to 52 weeks