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

NCT02137629 | Completed

• 1 other identifier: NIPMS-Celgene-KOR-001
• Study Type: observational
• Target: 511
• Locations: 1 country
• Sites: 48

Brief 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. 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

Keywords

Myelodysplastic syndromes; Vidaza; Observational study; Korea

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 6 years

Secondary Outcomes (1)

• Overall Response Rate

  Up to 24 weeks

Study Arms (1)

Korean patients

All Korean patients intended to be treated with Vidaza® according to the approved package insert

Drug: Vidaza®

Interventions

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.

Korean patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

Sponsors & Collaborators

• Celgene: lead

Study Sites (48)

Hallym University Sacred Heart Hospital

Anyang, 431-796, South Korea

Location

Soon Chun Hyang University Hospital Bucheon

Bucheon-si, 420-853, South Korea

Location

Kosin University Gospel Hospital

Busan, 602-030, South Korea

Location

Dong-a University Medical Center

Busan, 602-715, South Korea

Location

Pusan National University Hospital

Busan, 602-739, South Korea

Location

Inje University Busan Paik Hospital

Busan, 614-735, South Korea

Location

Inje University Haeundae Paik Hospital

Busan, 614-735, South Korea

Location

Dongnam Inst. of Radiological & Medical Science

Busan, 619-953, South Korea

Location

Soon Chun Hyang University Hospital Cheonan

Cheonan, 330-721, South Korea

Location

Chungbuk National University Hospital

Cheongju-si, 138-736, South Korea

Location

Keimyung University Dongsan Hospital

Daegu, 700-712, South Korea

Location

Kyungpook National University Hospital

Daegu, 700-712, South Korea

Location

Daegu Fatima Hospita

Daegu, 701-010, South Korea

Location

Yeungnam University Medical Center

Daegu, 705-030, South Korea

Location

Daegu Catholic University Medical Center

Daegu, 705-034, South Korea

Location

Chungnam National University Hospital

Daejeon, 301-721, South Korea

Location

Eulji University Hospital - Daejeon

Daejeon, 302-799, South Korea

Location

Dongguk University Ilsan Hospital

Goyang, 410-773, South Korea

Location

Inje University Ilsan Paik Hospital

Goyang, 411-706, South Korea

Location

National Health Insurance Service Ilsan Hospital

Goyang, 411-719, South Korea

Location

Chosun University Hospital

Gwangju, 501-717, South Korea

Location

Dongguk University Gyeongju Hospital

Gyeongju, 780-350, South Korea

Location

Hwasun Chonnam National University Hospital

Hwasun-gun, 519-809, South Korea

Location

Wonkwang University Hospital

Iksan, 570-711, South Korea

Location

Inha University Hospital

Incheon, 400-711, South Korea

Location

Gacheon University Gil Hospital

Incheon, 405-760, South Korea

Location

Chonbuk National University Hospital

Jeonju, 561-712, South Korea

Location

Gyeongsang National University Hospital

Jinju, 660-702, South Korea

Location

Inje University Seoul Paik Hospital

Seoul, 100-032, South Korea

Location

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Severance Hospital

Seoul, 120-752, South Korea

Location

Kyunghee University Medical Center

Seoul, 130-702, South Korea

Location

Seoul Medical Center

Seoul, 131-865, South Korea

Location

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Seoul National University Hospital

Seoul, 135-710, South Korea

Location

Korea University Anam Hospital

Seoul, 136-705, South Korea

Location

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, 137-701, South Korea

Location

Asan Medical Center

Seoul, 138-736, South Korea

Location

Korea Cancer Center Hospital

Seoul, 139-706, South Korea

Location

Inje University Sanggye Paik Hospital

Seoul, 139-707, South Korea

Location

Konkuk University Hospital

Seoul, 143-729, South Korea

Location

Korea University Guro Hospital

Seoul, 152-703, South Korea

Location

Boramae Medical Center

Seoul, 156-707, South Korea

Location

Chung-ang University Hospital

Seoul, 156-755, South Korea

Location

Ewha Womans University Mokdong Hospital

Seoul, 158-710, South Korea

Location

The Catholic University of Korea, St. Vicent's Hospital

Suwon, 442-723, South Korea

Location

Ajou University Medical Center

Suwon, 443-721, South Korea

Location

Ulsan University Hospital

Ulsan, 682-714, South Korea

Location

MeSH Terms

Conditions

Myelodysplastic Syndromes

Interventions

Azacitidine

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Miran Moon

  Clinical Research Manager, Celgene Korea

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2014
• First Posted: May 14, 2014
• Study Start: December 27, 2010
• Primary Completion: May 19, 2016
• Study Completion: May 19, 2016
• Last Updated: November 18, 2019

Record last verified: 2019-11

Locations

KR (48)