Multicenter Retrospective Analysis About the Clinical Characteristics of Korean Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients
1 other identifier
observational
350
1 country
1
Brief Summary
Paroxysmal nocturnal hemoglobinuria (PNH) is a hematopoietic stem cell disorder in which unregulated activation of the complement system leads to significant ischemic morbidities with shortened lifespan. Life-threatening thromboembolism (TE) is the most feared complication of PNH, accounting for up to 45% of patient deaths. It is estimated that 40% of PNH patients experience a clinically evident TE and 60% of patients without clinically diagnosed TE demonstrate TE by high-sensitivity MRI, indicating the ongoing thrombotic risk in most patients with PNH. Much of these data come from PNH patients from European descent. To understand the impact of TE in patients with PNH from non-European regions, we performed this study to evaluate the clinical characteristics of Korean patients with PNH.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2010
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 18, 2010
CompletedFirst Posted
Study publicly available on registry
October 20, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedOctober 20, 2010
October 1, 2010
3 months
October 18, 2010
October 19, 2010
Conditions
Eligibility Criteria
Korean PNH patients: diagnosis confirmed by Ham's test or Flow cytometry
You may qualify if:
- Diagnosis confirmed by Ham's test or Flow cytometry Patients have any Flow cytometry data
You may not qualify if:
- Patients have no Flow cytometry data
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Division of Hematology Oncology, Samsung Medical Center
Seoul, 135-710, South Korea
Related Publications (3)
Jang JH, Kim JS, Yoon SS, Lee JH, Kim YK, Jo DY, Chung J, Sohn SK, Lee JW. Predictive Factors of Mortality in Population of Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH): Results from a Korean PNH Registry. J Korean Med Sci. 2016 Feb;31(2):214-21. doi: 10.3346/jkms.2016.31.2.214. Epub 2016 Jan 26.
PMID: 26839475DERIVEDKim JS, Jang JH, Yoon SS, Lee JH, Kim YK, Jo DY, Chung JS, Sohn SK, Lee JW. Distinct subgroups of paroxysmal nocturnal hemoglobinuria (PNH) with cytopenia: results from South Korean National PNH Registry. Ann Hematol. 2016 Jan;95(1):125-133. doi: 10.1007/s00277-015-2511-z. Epub 2015 Sep 29.
PMID: 26416513DERIVEDLee JW, Jang JH, Kim JS, Yoon SS, Lee JH, Kim YK, Jo DY, Chung J, Sohn SK. Clinical signs and symptoms associated with increased risk for thrombosis in patients with paroxysmal nocturnal hemoglobinuria from a Korean Registry. Int J Hematol. 2013 Jun;97(6):749-57. doi: 10.1007/s12185-013-1346-4. Epub 2013 May 1.
PMID: 23636668DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jun Ho Jang, M.D.
Samsung Medical Center
Study Design
- Study Type
- observational
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 18, 2010
First Posted
October 20, 2010
Study Start
August 1, 2010
Primary Completion
November 1, 2010
Study Completion
December 1, 2010
Last Updated
October 20, 2010
Record last verified: 2010-10