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

November 14, 2019 updated by: Celgene

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
511

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Anyang, Korea, Republic of, 431-796
        • Hallym University Sacred Heart Hospital
      • Bucheon, Korea, Republic of, 420-853
        • Soon Chun Hyang University Hospital Bucheon
      • Busan, Korea, Republic of, 602-739
        • Pusan National University Hospital
      • Busan, Korea, Republic of, 614-735
        • Inje university busan paik hospital
      • Busan, Korea, Republic of, 602-715
        • Dong-A University Medical Center
      • Busan, Korea, Republic of, 602-030
        • Kosin university gospel hospital
      • Busan, Korea, Republic of, 614-735
        • Inje University Haeundae Paik Hospital
      • Busan, Korea, Republic of, 619-953
        • Dongnam Inst. of Radiological & Medical Science
      • Cheonan, Korea, Republic of, 330-721
        • Soon Chun Hyang University Hospital Cheonan
      • Cheongju, Korea, Republic of, 138-736
        • Chungbuk National University Hospital
      • Daegu, Korea, Republic of, 700-712
        • Keimyung University Dongsan Hospital
      • Daegu, Korea, Republic of, 700-712
        • Kyungpook National University Hospital
      • Daegu, Korea, Republic of, 701-010
        • Daegu Fatima Hospita
      • Daegu, Korea, Republic of, 705-030
        • Yeungnam University Medical Center
      • Daegu, Korea, Republic of, 705-034
        • Daegu Catholic University Medical Center
      • Daejeon, Korea, Republic of, 301-721
        • Chungnam national university hospital
      • Daejeon, Korea, Republic of, 302-799
        • Eulji University Hospital - Daejeon
      • Goyang, Korea, Republic of, 411-706
        • Inje University Ilsan Paik Hospital
      • Goyang, Korea, Republic of, 410-773
        • Dongguk University Ilsan Hospital
      • Goyang, Korea, Republic of, 411-719
        • National Health Insurance Service Ilsan Hospital
      • Gwangju, Korea, Republic of, 501-717
        • Chosun university hospital
      • Gyeongju, Korea, Republic of, 780-350
        • Dongguk University Gyeongju Hospital
      • Hwasun-gun, Korea, Republic of, 519-809
        • Hwasun Chonnam National University Hospital
      • Iksan, Korea, Republic of, 570-711
        • Wonkwang University Hospital
      • Incheon, Korea, Republic of, 400-711
        • Inha University Hospital
      • Incheon, Korea, Republic of, 405-760
        • Gacheon University Gil Hospital
      • Jeonju, Korea, Republic of, 561-712
        • Chonbuk National University Hospital
      • Jinju, Korea, Republic of, 660-702
        • Gyeongsang National University Hospital
      • Seoul, Korea, Republic of, 135-710
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 138-736
        • Asan Medical Center
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 156-755
        • Chung-Ang University Hospital
      • Seoul, Korea, Republic of, 152-703
        • Korea University Guro Hospital
      • Seoul, Korea, Republic of, 120-752
        • Severance Hospital
      • Seoul, Korea, Republic of, 136-705
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of, 137-701
        • The Catholic University of Korea, Seoul St. Mary's Hospital
      • Seoul, Korea, Republic of, 100-032
        • Inje University Seoul Paik Hospital
      • Seoul, Korea, Republic of, 158-710
        • Ewha Womans University Mokdong Hospital
      • Seoul, Korea, Republic of, 139-706
        • Korea Cancer Center Hospital
      • Seoul, Korea, Republic of, 143-729
        • Konkuk University Hospital
      • Seoul, Korea, Republic of, 156-707
        • Boramae Medical Center
      • Seoul, Korea, Republic of, 130-702
        • Kyunghee University Medical Center
      • Seoul, Korea, Republic of, 139-707
        • Inje University Sanggye Paik Hospital
      • Seoul, Korea, Republic of, 131-865
        • Seoul Medical Center
      • Seoul, Korea, Republic of, 135-710
        • Seoul National University Hospital
      • Suwon, Korea, Republic of, 442-723
        • The Catholic University of Korea, St. Vicent's Hospital
      • Suwon, Korea, Republic of, 443-721
        • Ajou University Medical Center
      • Ulsan, Korea, Republic of, 682-714
        • Ulsan university hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All Korean patients who are intended to be treated with VIDAZA® according to the approved package insert

Description

Inclusion Criteria:

  • Korean male or female Myelodysplastic Syndrome patients treated with VIDAZA®(subcutaneous or intravenous) according to the approved package insert

Exclusion Criteria:

  • There's no exclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Korean patients
All Korean patients intended to be treated with Vidaza® according to the approved package insert
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Up to 6 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Response Rate
Time Frame: Up to 24 weeks
Number of patients with response (CR, PR, mCR) based on the International Working Group (IWG 2006) response criteria for Myelodysplastic Syndrome (MDS)
Up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Celgene

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Miran Moon, Clinical Research Manager, Celgene Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 27, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 19, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 19, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 7, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 14, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 18, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NIPMS-Celgene-KOR-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Myelodysplastic Syndrome

Clinical Trials on Vidaza®

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings