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

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

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

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
Intervention / Treatment
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

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

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

Celgene

Investigators

  • 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)

December 27, 2010

Primary Completion (Actual)

May 19, 2016

Study Completion (Actual)

May 19, 2016

Study Registration Dates

First Submitted

February 7, 2014

First Submitted That Met QC Criteria

May 12, 2014

First Posted (Estimate)

May 14, 2014

Study Record Updates

Last Update Posted (Actual)

November 18, 2019

Last Update Submitted That Met QC Criteria

November 14, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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.

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