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Anagre Cap. in Patients With High-Risk Essential Thrombocythemia

NCT03232177 — Phase 4, Completed, 70 participants, Yuhan Corporation

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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

RegistryNCT03232177
StatusCompleted
PhasePhase 4
Study typeInterventional; na, single group, masking: none, treatment
Enrollment70 (Actual)
SponsorYuhan Corporation (Industry)
ConditionsEssential Thrombocythemia
InterventionsAnagre Cap. (Drug)
Datesstart 2017-06-05, primary completion 2020-12-05, completion 2020-12-05, first posted 2017-07-27, last updated 2021-07-21
Locations21 sites in South Korea

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-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.

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+Arms and interventions

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

+Outcome measures

Primary outcomes

  • response rate for less than 60 X 10^4/ul in platelet count [at week 8]

Secondary outcomes

  • 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 outcomes

  • 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]

+Eligibility

Sex: All, ages: 19 Years to any

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

+Locations (21)

FacilityCityCountryStatus
National Health Insurance Service Ilsan HospitalGoyang-si, Gyeonggi-doSouth Korea
The Catholic University of Korea. ST. Vincents HospitalSuwon, Gyeonggi-doSouth Korea
Hallym UNIV. Medical CenterAnyangSouth Korea
Daegu Catholic University Medical CenterDaeguSouth Korea
Keimyung University Dongsan Medical CenterDaeguSouth Korea
Kyungpook national university hospitalDaeguSouth Korea
Dongguk University Medical CenterGoyangSouth Korea
Cheonnam National University Hwasun HospitalHwasunSouth Korea
Gachon University Gil Medical CenterIncheonSouth Korea
Inha University HospitalIncheonSouth Korea
Jeju National University HospitalJeju CitySouth Korea
Pusan National University HospitalPusanSouth Korea
Ewha Wonans University Mokdong HospitalSeoulSouth Korea
Hallym UNIV. Medical CenterSeoulSouth Korea
Inje University Sanggye Paik HospitalSeoulSouth Korea
Korea University Anam HospitalSeoulSouth Korea
Seoul National University HospitalSeoulSouth Korea
SMG - SNU Boramae Medical CenterSeoulSouth Korea
Soon Chun Hyang University Hospital SeoulSeoulSouth Korea
Veterans Health Service medical CenterSeoulSouth Korea
Yonsei University Health System, SEVERANCE HOSPITALSeoulSouth Korea

My Notes