Clinical trial NCT03232177: Anagre Cap. in Patients With High-Risk Essential Thrombocythemia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Essential Thrombocythemia
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2017-07-27
Enrollment: 70
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: response rate for less than 60 X 10^4/ul in platelet count
timeFrame: at week 8
Secondary outcomes:
measure: response rate for less than 60 X 10^4/ul in platelet count
timeFrame: at week 52
measure: changes from baseline in 50% reduction rate in platelet count
timeFrame: up to 52 weeks
measure: response rate for less than 40 X 10^4/ul in platelet count
timeFrame: up to 52 weeks
measure: cumulative incidence of essential thrombocythemia related events (e.g thromboembolic or hemorrhagic events)
timeFrame: at 52 week
measure: incidence of adverse events
timeFrame: up to 52 weeks
Other outcomes:
measure: expression of MPN-oncogene(JAK2/CALR/MPL)
timeFrame: at 52 week
measure: genomic biomarker search for prediction of side effects of anagrelide
timeFrame: at 52 week
Locations:
city: Goyang
country: Korea, Republic of
facility: National Health Insurance Service Ilsan Hospital
state: Gyeonggi
city: Suwon-si
country: Korea, Republic of
facility: The Catholic University of Korea. ST. Vincents Hospital
state: Gyeonggi
city: Anyang
country: Korea, Republic of
facility: Hallym UNIV. Medical Center
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daegu
country: Korea, Republic of
facility: Kyungpook national university hospital
city: Goyang
country: Korea, Republic of
facility: Dongguk University Medical Center
city: Hwasun
country: Korea, Republic of
facility: Cheonnam National University Hwasun Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Jeju City
country: Korea, Republic of
facility: Jeju National University Hospital
city: Pusan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Seoul
country: Korea, Republic of
facility: Ewha Wonans University Mokdong Hospital
city: Seoul
country: Korea, Republic of
facility: Hallym UNIV. Medical Center
city: Seoul
country: Korea, Republic of
facility: Inje University Sanggye Paik Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: SMG - SNU Boramae Medical Center
city: Seoul
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Seoul
city: Seoul
country: Korea, Republic of
facility: Veterans Health Service medical Center
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, SEVERANCE HOSPITAL
Study officials:
References: