Anagre Cap. in Patients With High-Risk Essential Thrombocythemia

Sponsor
Yuhan Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT03232177
Collaborator
(none)
70
21
1
42
3.3
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Anagre Cap.
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
70 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jun 5, 2017
Actual Primary Completion Date :
Dec 5, 2020
Actual Study Completion Date :
Dec 5, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Anagre Cap.

twice a day

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

  1. response rate for less than 60 X 10^4/ul in platelet count [at week 52]

  2. changes from baseline in 50% reduction rate in platelet count [up to 52 weeks]

  3. response rate for less than 40 X 10^4/ul in platelet count [up to 52 weeks]

  4. cumulative incidence of essential thrombocythemia related events (e.g thromboembolic or hemorrhagic events) [at 52 week]

  5. incidence of adverse events [up to 52 weeks]

Other Outcome Measures

  1. 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

  2. genomic biomarker search for prediction of side effects of anagrelide [at 52 week]

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Health Insurance Service Ilsan Hospital Goyang Gyeonggi Korea, Republic of
2 The Catholic University of Korea. ST. Vincents Hospital Suwon-si Gyeonggi Korea, Republic of
3 Hallym UNIV. Medical Center Anyang Korea, Republic of
4 Daegu Catholic University Medical Center Daegu Korea, Republic of
5 Keimyung University Dongsan Medical Center Daegu Korea, Republic of
6 Kyungpook national university hospital Daegu Korea, Republic of
7 Dongguk University Medical Center Goyang Korea, Republic of
8 Cheonnam National University Hwasun Hospital Hwasun Korea, Republic of
9 Gachon University Gil Medical Center Incheon Korea, Republic of
10 Inha University Hospital Incheon Korea, Republic of
11 Jeju National University Hospital Jeju City Korea, Republic of
12 Pusan National University Hospital Pusan Korea, Republic of
13 Ewha Wonans University Mokdong Hospital Seoul Korea, Republic of
14 Hallym UNIV. Medical Center Seoul Korea, Republic of
15 Inje University Sanggye Paik Hospital Seoul Korea, Republic of
16 Korea University Anam Hospital Seoul Korea, Republic of
17 Seoul National University Hospital Seoul Korea, Republic of
18 SMG - SNU Boramae Medical Center Seoul Korea, Republic of
19 Soon Chun Hyang University Hospital Seoul Seoul Korea, Republic of
20 Veterans Health Service medical Center Seoul Korea, Republic of
21 Yonsei University Health System, SEVERANCE HOSPITAL Seoul Korea, Republic of

Sponsors and Collaborators

  • Yuhan Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yuhan Corporation
ClinicalTrials.gov Identifier:
NCT03232177
Other Study ID Numbers:
  • YMC018
First Posted:
Jul 27, 2017
Last Update Posted:
Jul 21, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 21, 2021