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Multicenter Retrospective Analysis About the Clinical Characteristics of Korean Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients

NCT ID: NCT01224483

Last Updated: 2010-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-08-31

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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To evaluate the clinical characteristics in Korean PNH patients

Conditions

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Hemoglobinuria, Paroxysmal

Study Design

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Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Diagnosis confirmed by Ham's test or Flow cytometry Patients have any Flow cytometry data

Exclusion Criteria

* Patients have no Flow cytometry data
Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Aplastic Working Party, The Korean Society of Hematology

Principal Investigators

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Jun Ho Jang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Division of Hematology Oncology, Samsung Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Facility Contacts

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Jun Ho Jang, M.D.

Role: primary

[email protected]
82-2-3410-0918

References

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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.

Reference Type DERIVED
PMID: 26839475 (View on PubMed)

Kim 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.

Reference Type DERIVED
PMID: 26416513 (View on PubMed)

Lee 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.

Reference Type DERIVED
PMID: 23636668 (View on PubMed)

Other Identifiers

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2010-02-048

Identifier Type: -

Identifier Source: org_study_id