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Anagre Cap. in Patients With High-Risk Essential Thrombocythemia

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ClinicalTrials.gov Identifier: NCT03232177
Recruitment Status : Recruiting
First Posted : July 27, 2017
Last Update Posted : April 12, 2019
Sponsor:
Information provided by (Responsible Party):
Yuhan Corporation

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
Essential Thrombocythemia Drug: Anagre Cap. Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
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 : June 5, 2017
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021


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




Primary Outcome Measures :
  1. response rate for less than 60 X 10^4/ul in platelet count [ Time Frame: at week 8 ]

Secondary Outcome Measures :
  1. response rate for less than 60 X 10^4/ul in platelet count [ Time Frame: at week 52 ]
  2. changes from baseline in 50% reduction rate in platelet count [ Time Frame: up to 52 weeks ]
  3. response rate for less than 40 X 10^4/ul in platelet count [ Time Frame: up to 52 weeks ]
  4. cumulative incidence of essential thrombocythemia related events (e.g thromboembolic or hemorrhagic events) [ Time Frame: at 52 week ]
  5. incidence of adverse events [ Time Frame: up to 52 weeks ]

Other Outcome Measures:
  1. expression of MPN-oncogene(JAK2/CALR/MPL) [ Time Frame: 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 [ Time Frame: at 52 week ]


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03232177


Contacts
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Contact: Hojin Lee 82 2 828 0548 hjlee@yuhan.co.kr
Contact: Dong-Yeop Shin, MD stephano.dyshin@gmail.com

Locations
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Korea, Republic of
National Health Insurance Service Ilsan Hospital Not yet recruiting
Goyang, Gyeonggi, Korea, Republic of
The Catholic University of Korea. ST. Vincents Hospital Not yet recruiting
Suwon-si, Gyeonggi, Korea, Republic of
Hallym UNIV. Medical Center Recruiting
Anyang, Korea, Republic of
Daegu Catholic University Medical Center Not yet recruiting
Daegu, Korea, Republic of
Keimyung University Dongsan Medical Center Not yet recruiting
Daegu, Korea, Republic of
Kyungpook national university hospital Not yet recruiting
Daegu, Korea, Republic of
Dongguk University Medical Center Not yet recruiting
Goyang, Korea, Republic of
Cheonnam National University Hwasun Hospital Not yet recruiting
Hwasun, Korea, Republic of
Gachon University Gil Medical Center Recruiting
Incheon, Korea, Republic of
Inha University Hospital Not yet recruiting
Incheon, Korea, Republic of
Jeju National University Hospital Not yet recruiting
Jeju City, Korea, Republic of
Pusan National University Hospital Not yet recruiting
Pusan, Korea, Republic of
Ewha Wonans University Mokdong Hospital Not yet recruiting
Seoul, Korea, Republic of
Hallym UNIV. Medical Center Not yet recruiting
Seoul, Korea, Republic of
Inje University Sanggye Paik Hospital Not yet recruiting
Seoul, Korea, Republic of
Korea University Anam Hospital Not yet recruiting
Seoul, Korea, Republic of
Seoul National University Hospital Not yet recruiting
Seoul, Korea, Republic of
SMG - SNU Boramae Medical Center Not yet recruiting
Seoul, Korea, Republic of
Soon Chun Hyang University Hospital Seoul Not yet recruiting
Seoul, Korea, Republic of
Veterans Health Service medical Center Not yet recruiting
Seoul, Korea, Republic of
Yonsei University Health System, SEVERANCE HOSPITAL Not yet recruiting
Seoul, Korea, Republic of
Sponsors and Collaborators
Yuhan Corporation

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Responsible Party: Yuhan Corporation
ClinicalTrials.gov Identifier: NCT03232177     History of Changes
Other Study ID Numbers: YMC018
First Posted: July 27, 2017    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Thrombocytosis
Thrombocythemia, Essential
Blood Platelet Disorders
Hematologic Diseases
Myeloproliferative Disorders
Bone Marrow Diseases
Blood Coagulation Disorders
Hemorrhagic Disorders