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
1 other identifier
interventional
70
1 country
21
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jun 2017
Longer than P75 for phase_4
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 5, 2017
CompletedFirst Submitted
Initial submission to the registry
July 11, 2017
CompletedFirst Posted
Study publicly available on registry
July 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 5, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 5, 2020
CompletedJuly 21, 2021
July 1, 2021
3.5 years
July 11, 2017
July 20, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
response rate for less than 60 X 10^4/ul in platelet count
at week 8
Secondary Outcomes (5)
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 (2)
expression of MPN-oncogene(JAK2/CALR/MPL)
at 52 week
genomic biomarker search for prediction of side effects of anagrelide
at 52 week
Study Arms (1)
Anagre Cap.
EXPERIMENTALtwice a day
Interventions
from 0.5mg twice a day to maximally increase total10mg in 8 weeks and maintain maximal tolerable dose to 104 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
National Health Insurance Service Ilsan Hospital
Goyang-si, Gyeonggi-do, South Korea
The Catholic University of Korea. ST. Vincents Hospital
Suwon, Gyeonggi-do, South Korea
Hallym UNIV. Medical Center
Anyang, South Korea
Daegu Catholic University Medical Center
Daegu, South Korea
Keimyung University Dongsan Medical Center
Daegu, South Korea
Kyungpook national university hospital
Daegu, South Korea
Dongguk University Medical Center
Goyang, South Korea
Cheonnam National University Hwasun Hospital
Hwasun, South Korea
Gachon University Gil Medical Center
Incheon, South Korea
Inha University Hospital
Incheon, South Korea
Jeju National University Hospital
Jeju City, South Korea
Pusan National University Hospital
Pusan, South Korea
Ewha Wonans University Mokdong Hospital
Seoul, South Korea
Hallym UNIV. Medical Center
Seoul, South Korea
Inje University Sanggye Paik Hospital
Seoul, South Korea
Korea University Anam Hospital
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
SMG - SNU Boramae Medical Center
Seoul, South Korea
Soon Chun Hyang University Hospital Seoul
Seoul, South Korea
Veterans Health Service medical Center
Seoul, South Korea
Yonsei University Health System, SEVERANCE HOSPITAL
Seoul, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 11, 2017
First Posted
July 27, 2017
Study Start
June 5, 2017
Primary Completion
December 5, 2020
Study Completion
December 5, 2020
Last Updated
July 21, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share