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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Samsung Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01224483
First received: October 18, 2010
Last updated: October 19, 2010
Last verified: October 2010
History of Changes
  Purpose

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.


Condition
Hemoglobinuria, Paroxysmal

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Multicenter Retrospective Analysis About the Clinical Characteristics of Korean Patients With PNH

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Samsung Medical Center:

Estimated Enrollment: 350
Study Start Date: August 2010
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Detailed Description:

To evaluate the clinical characteristics in Korean PNH patients

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Korean PNH patients: diagnosis confirmed by Ham's test or Flow cytometry

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01224483

Locations
Korea, Republic of
Division of Hematology Oncology, Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Jun Ho Jang, M.D.     82-2-3410-0918     smcjunhojang@gmail.com    
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Jun Ho Jang, M.D. Samsung Medical Center
  More Information

No publications provided

Responsible Party: Jun Ho Jang, Aplastic Working Party, The Korean Society of Hematology
ClinicalTrials.gov Identifier: NCT01224483     History of Changes
Other Study ID Numbers: 2010-02-048
Study First Received: October 18, 2010
Last Updated: October 19, 2010
Health Authority: South Korea: Institutional Review Board

Additional relevant MeSH terms:
Hemoglobinuria
Hemoglobinuria, Paroxysmal
Proteinuria
Urination Disorders
Urologic Diseases
Urological Manifestations
 Signs and Symptoms
Anemia, Hemolytic
Anemia
Hematologic Diseases
Myelodysplastic Syndromes
Bone Marrow Diseases

ClinicalTrials.gov processed this record on May 21, 2013