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

• Conditions: Hemoglobinuria, Paroxysmal

• Registration Number: NCT01224483
• Lead Sponsor: Samsung Medical Center

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.

Detailed Description

To evaluate the clinical characteristics in Korean PNH patients

Study Timeline

• Study Start: 2010-08
• Status Verified: 2010-10
• Study First Submitted: 2010-10-18
• Study First Submitted QC: 2010-10-19
• Last Update Submitted: 2010-10-19
• Study First Posted: 2010-10-20
• Last Update Posted: 2010-10-20
• Primary Completion: 2010-11
• Study Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 350

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Division of Hematology Oncology, Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of