Essential ThrombocythemiaPhase 4NCT03232177
Anagre Cap. in Patients With High-Risk Essential Thrombocythemia
A Phase 4 study testing Anagre Cap. in people with Essential Thrombocythemia, run by Yuhan Corporation at 21 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Essential Thrombocythemia
- What is being tested?
- Anagre Cap.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 21 sitesSouth Korea
- Study dates
- 5 Jun 2017to 5 Dec 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Clinically significant bradycardia (<less than 50 per minute)
- History of clinically proven myocardial infarction and unstable angina within 3 months
- Pregnant women, nursing mothers
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
South Korea21 sites
Hallym UNIV. Medical Center
Anyang
Daegu Catholic University Medical Center
Daegu
Keimyung University Dongsan Medical Center
Daegu
Kyungpook national university hospital
Daegu
Dongguk University Medical Center
Goyang
National Health Insurance Service Ilsan Hospital
Goyang-si, Gyeonggi-do
Cheonnam National University Hwasun Hospital
Hwasun
Gachon University Gil Medical Center
Incheon
Inha University Hospital
Incheon
Jeju National University Hospital
Jeju City
Pusan National University Hospital
Pusan
Ewha Wonans University Mokdong Hospital
Seoul
Hallym UNIV. Medical Center
Seoul
Inje University Sanggye Paik Hospital
Seoul
Korea University Anam Hospital
Seoul
Seoul National University Hospital
Seoul
SMG - SNU Boramae Medical Center
Seoul
Soon Chun Hyang University Hospital Seoul
Seoul
Veterans Health Service medical Center
Seoul
Yonsei University Health System, SEVERANCE HOSPITAL
Seoul
The Catholic University of Korea. ST. Vincents Hospital
Suwon, Gyeonggi-do
About this study
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
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.
- Conditions
- Essential Thrombocythemia
- Being tested
- Anagre Cap.
- Medical subject headings
- Thrombocythemia, Essential
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anagre Cap.Drug
from 0.5mg twice a day to maximally increase total10mg in 8 weeks and maintain maximal tolerable dose to 104 weeks
| Study group | Role | What they receive |
|---|---|---|
| Anagre Cap. | Experimental | twice a day Receives: Drug: Anagre Cap. |
What is being measured
The primary outcome is the main question the study is designed to answer.
response rate for less than 60 X 10^4/ul in platelet count
Measured: at week 8
Secondary outcomes (5)
response rate for less than 60 X 10^4/ul in platelet count
Measured: at week 52
changes from baseline in 50% reduction rate in platelet count
Measured: up to 52 weeks
response rate for less than 40 X 10^4/ul in platelet count
Measured: up to 52 weeks
cumulative incidence of essential thrombocythemia related events (e.g thromboembolic or hemorrhagic events)
Measured: at 52 week
incidence of adverse events
Measured: up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2017
- Study start5 Jun 2017
- Primary completion5 Dec 2020
- Study completion5 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential ThrombocythemiaStudies of the same condition, open and under way.
- More trials run by Yuhan CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03232177
- Sponsor's protocol ID
- YMC018
- Status last verified
- Jul 2021
- First submitted
- 11 Jul 2017
- Last updated
- 21 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03232177
- Acronym / sponsor ID
- YMC018
- Conditions
- Essential Thrombocythemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- 5 Jun 2017 (actual)
- Primary completion
- 5 Dec 2020 (actual)
- Study completion
- 5 Dec 2020 (actual)
- First posted
- 27 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anagre Cap. | Experimental | Drug: Anagre Cap.twice a day |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with essential thrombocythemia according to WHO 2008
- Any of the following as high-risk patient
Key exclusion criteria (9 listed)
- Patients with an adverse drug reaction or intolerability to anagrelide
- Any of the following cardiac abnormalities;
- Pregnant women, nursing mothers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anagre Cap.from 0.5mg twice a day to maximally increase total10mg in 8 weeks and maintain maximal tolerable dose to 104 weeks | Drug | Anagre Cap. |
Primary outcome
response rate for less than 60 X 10^4/ul in platelet count
Time frame: at week 8
5 secondary outcomes
response rate for less than 60 X 10^4/ul in platelet count
Time frame: at week 52
changes from baseline in 50% reduction rate in platelet count
Time frame: up to 52 weeks
response rate for less than 40 X 10^4/ul in platelet count
Time frame: up to 52 weeks
cumulative incidence of essential thrombocythemia related events (e.g thromboembolic or hemorrhagic events)
Time frame: at 52 week
incidence of adverse events
Time frame: up to 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Anagre Cap. in people with Essential Thrombocythemia, run by Yuhan Corporation at 21 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
response rate for less than 60 X 10^4/ul in platelet count (time frame: at week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2021.