We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2010 by Samsung Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01224483
First Posted: October 20, 2010
Last Update Posted: October 20, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Samsung Medical Center
  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:


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   1 Year and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Submitted: October 18, 2010
First Posted: October 20, 2010
Last Update Posted: October 20, 2010
Last Verified: October 2010

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