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

Sponsors

Lead Sponsor: Yuhan Corporation

Source 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.

Overall Status Recruiting
Start Date June 5, 2017
Completion Date June 2021
Primary Completion Date June 2021
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
response rate for less than 60 X 10^4/ul in platelet count at week 8
Secondary Outcome
Measure Time Frame
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
Enrollment 70
Condition
Intervention

Intervention Type: Drug

Intervention Name: Anagre Cap.

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

Arm Group Label: Anagre Cap.

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 (

- History of clinically proven myocardial infarction and unstable angina within 3 months

- Pregnant women, nursing mothers

Gender: All

Minimum Age: 19 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Contact

Last Name: Hojin Lee

Phone: 82 2 828 0548

Email: [email protected]

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

Korea, Republic of

Verification Date

June 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Anagre Cap.

Type: Experimental

Description: twice a day

Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov