Hemoglobinuria, Paroxysmal Clinical Trial
Official title:
Multicenter Retrospective Analysis About the Clinical Characteristics of Korean Patients With PNH
| Verified date | October 2010 |
| Source | Samsung Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | South Korea: Institutional Review Board |
| Study type | Observational |
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.
| Status | Recruiting |
| Enrollment | 350 |
| Est. completion date | December 2010 |
| Est. primary completion date | November 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 1 Year and older |
| Eligibility |
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 |
Time Perspective: Retrospective
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Division of Hematology Oncology, Samsung Medical Center | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Samsung Medical Center |
Korea, Republic of,
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