Myelodysplastic SyndromeNCT02137629
Post Marketing Surveillance to Collect and Evaluate the Safety and Efficacy Information of Korean MDS Patients Treated With VIDAZA®, After Approval of Marketing Authorization for New Drug in Korea
An observational study of Myelodysplastic Syndrome, run by Celgene at 48 sites in South Korea.
Trial summary
The main purpose of VIDAZA® DUE (Drug Use Examination) is to collect and evaluate the safety information of Korean MDS patients treated with VIDAZA®(SC or IV) according to the approved package insert, after approval of marketing authorization for new drug in Korea. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndrome
- What is being tested?
- Vidaza®
- Type of treatment
- Injection or infusion
- How many people
- 511 participants
- Where
- 48 sitesSouth Korea
- Study dates
- 27 Dec 2010to 19 May 2016
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All Korean patients who are intended to be treated with VIDAZA® according to the approved package insert
Who may be able to join
- Korean male or female Myelodysplastic Syndrome patients treated with VIDAZA®(subcutaneous or intravenous) according to the approved package insert
Who cannot join
- There's no exclusion criteria
Trial locations and contacts
48 sites in 1 country.
48 sites in 1 country
South Korea48 sites
Hallym University Sacred Heart Hospital
Anyang, 431-796
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, 420-853
Kosin University Gospel Hospital
Busan, 602-030
Dong-a University Medical Center
Busan, 602-715
Pusan National University Hospital
Busan, 602-739
Inje University Busan Paik Hospital
Busan, 614-735
Inje University Haeundae Paik Hospital
Busan, 614-735
Dongnam Inst. of Radiological & Medical Science
Busan, 619-953
Soon Chun Hyang University Hospital Cheonan
Cheonan, 330-721
Chungbuk National University Hospital
Cheongju-si, 138-736
Keimyung University Dongsan Hospital
Daegu, 700-712
Kyungpook National University Hospital
Daegu, 700-712
Daegu Fatima Hospita
Daegu, 701-010
Yeungnam University Medical Center
Daegu, 705-030
Daegu Catholic University Medical Center
Daegu, 705-034
Chungnam National University Hospital
Daejeon, 301-721
Eulji University Hospital - Daejeon
Daejeon, 302-799
Dongguk University Ilsan Hospital
Goyang, 410-773
Inje University Ilsan Paik Hospital
Goyang, 411-706
National Health Insurance Service Ilsan Hospital
Goyang, 411-719
Chosun University Hospital
Gwangju, 501-717
Dongguk University Gyeongju Hospital
Gyeongju, 780-350
Hwasun Chonnam National University Hospital
Hwasun-gun, 519-809
Wonkwang University Hospital
Iksan, 570-711
Inha University Hospital
Incheon, 400-711
Gacheon University Gil Hospital
Incheon, 405-760
Chonbuk National University Hospital
Jeonju, 561-712
Gyeongsang National University Hospital
Jinju, 660-702
Inje University Seoul Paik Hospital
Seoul, 100-032
Seoul National University Hospital
Seoul, 110-744
Severance Hospital
Seoul, 120-752
Kyunghee University Medical Center
Seoul, 130-702
Seoul Medical Center
Seoul, 131-865
Samsung Medical Center
Seoul, 135-710
Seoul National University Hospital
Seoul, 135-710
Korea University Anam Hospital
Seoul, 136-705
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 137-701
Asan Medical Center
Seoul, 138-736
Korea Cancer Center Hospital
Seoul, 139-706
Inje University Sanggye Paik Hospital
Seoul, 139-707
Konkuk University Hospital
Seoul, 143-729
Korea University Guro Hospital
Seoul, 152-703
Boramae Medical Center
Seoul, 156-707
Chung-ang University Hospital
Seoul, 156-755
Ewha Womans University Mokdong Hospital
Seoul, 158-710
The Catholic University of Korea, St. Vicent's Hospital
Suwon, 442-723
Ajou University Medical Center
Suwon, 443-721
Ulsan University Hospital
Ulsan, 682-714
About this study
Official title: VIDAZA® Drug Use Examination
The main purpose of VIDAZA® DUE (Drug Use Examination) is to collect and evaluate the safety information of Korean MDS patients treated with VIDAZA®(SC or IV) according to the approved package insert, after approval of marketing authorization for new drug in Korea. In addition, the efficacy information of VIDAZA® in clinical practice is collected and evaluated. This DUE is a prospective, multi-centre, observational, non-interventional, post-marketing surveillance. At least 600 patients' data that is eligible for safety assessment will be collected.
VIDAZA® DUE is to investigate frequency and change of Adverse Events(AEs)
/Adverse Drug Reactions(ADRs), Serious Adverse Events(SAEs)/Serious Adverse Drug Reactions(SADRs), unexpected AE/ADR and unexpected SAE/SADR, and to scrutinize factors influencing safety \& efficacy of the drug. It is necessary to examine patients' demographics and baseline characteristics, medical history, status of VIDAZA treatment, concomitant medication and evaluation of safety and final efficacy (best response) assessment.
- Conditions
- Myelodysplastic Syndrome
- Being tested
- Vidaza®
- Keywords
- Myelodysplastic syndromes, Vidaza, Observational study, Korea
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vidaza®Drug
The recommended starting dose for the first treatment for all patients regardless of baseline hematology values is Vidaza® 75mg/m2 subcutaneous(SC) injection or intravenous (IV) infusion, daily for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Korean patients | All Korean patients intended to be treated with Vidaza® according to the approved package insert Receives: Drug: Vidaza® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with Adverse Events (AE)
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
An SAE is any event that:
- is fatal or life threatening
- results in persistent or significant disability or or incapacity;
- requires or prolongs existing hospitalization;
- is a congenital anomaly/birth defect in the offspring of a patient who received medication;
- conditions not included above that may jeopardize the patient or require intervention to prevent one of the outcomes listed above.
Measured: Up to 6 years
Secondary outcomes (1)
Overall Response Rate
Number of patients with response (CR, PR, mCR) based on the International Working Group (IWG 2006) response criteria for Myelodysplastic Syndrome (MDS)
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2014 (estimated)
- Study start27 Dec 2010
- Primary completion19 May 2016
- Study completion19 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromeStudies of the same condition, open and under way.
- More trials run by CelgeneThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 511 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Miran Moon, Study director, Clinical Research Manager, Celgene Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02137629
- Sponsor's protocol ID
- NIPMS-Celgene-KOR-001
- Status last verified
- Nov 2019
- First submitted
- 7 Feb 2014
- Last updated
- 18 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VIDAZA® Drug Use Examination
- ClinicalTrials.gov ID
- NCT02137629
- Acronym / sponsor ID
- NIPMS-Celgene-KOR-001
- Conditions
- Myelodysplastic Syndrome
- Keywords
- Myelodysplastic syndromes, Vidaza, Observational study, Korea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 511 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 27 Dec 2010 (actual)
- Primary completion
- 19 May 2016 (actual)
- Study completion
- 19 May 2016 (actual)
- First posted
- 14 May 2014 (estimated)
- 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.
The main purpose of VIDAZA® DUE (Drug Use Examination) is to collect and evaluate the safety information of Korean MDS patients treated with VIDAZA®(SC or IV) according to the approved package insert, after approval of marketing authorization for new drug in Korea. In addition, the efficacy information of VIDAZA® in clinical practice is collected and evaluated. This DUE is a prospective, multi-centre, observational, non-interventional, post-marketing surveillance. At least 600 patients' data that is eligible for safety assessment will be collected.
VIDAZA® DUE is to investigate frequency and change of Adverse Events(AEs)
/Adverse Drug Reactions(ADRs), Serious Adverse Events(SAEs)/Serious Adverse Drug Reactions(SADRs), unexpected AE/ADR and unexpected SAE/SADR, and to scrutinize factors influencing safety \& efficacy of the drug. It is necessary to examine patients' demographics and baseline characteristics, medical history, status of VIDAZA treatment, concomitant medication and evaluation of safety and final efficacy (best response) assessment.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Korean patients | – | Drug: Vidaza®All Korean patients intended to be treated with Vidaza® according to the approved package insert |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All Korean patients who are intended to be treated with VIDAZA® according to the approved package insert
Key inclusion criteria (1 listed)
- Korean male or female Myelodysplastic Syndrome patients treated with VIDAZA®(subcutaneous or intravenous) according to the approved package insert
Key exclusion criteria (1 listed)
- There's no exclusion criteria
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 |
|---|---|---|
| Vidaza®The recommended starting dose for the first treatment for all patients regardless of baseline hematology values is Vidaza® 75mg/m2 subcutaneous(SC) injection or intravenous (IV) infusion, daily for 7 days. | Drug | Korean patients |
Primary outcome
Number of patients with Adverse Events (AE)
Time frame: Up to 6 years
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. An SAE is any event that: * is fatal or life threatening * results in persistent or significant disability or or incapacity; * requires or prolongs existing hospitalization; * is a congenital anomaly/birth defect in the offspring of a patient who received medication; * conditions not included above that may jeopardize the patient or require intervention to prevent one of the outcomes listed above.
1 secondary outcome
Overall Response Rate
Time frame: Up to 24 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 18 Nov 2019.
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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.
Miran Moon study director
Clinical Research Manager, Celgene Korea
48 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myelodysplastic Syndrome, run by Celgene at 48 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 1 inclusion and 1 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 18 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 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.
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?
Number of patients with Adverse Events (AE) (time frame: Up to 6 years). 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 18 Nov 2019.