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Females With Severe or Moderate Hemophilia A or B: an International Multi-center Study

Information source: Weill Medical College of Cornell University
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hemophilia A; Hemophilia B

Phase: N/A

Status: Completed

Sponsored by: Weill Medical College of Cornell University

Official(s) and/or principal investigator(s):
William B Mitchell, MD, Principal Investigator, Affiliation: Weill Medical College of Cornell University

Summary

This is a multi-center, international study designed to collect clinical, genetic and quality of life information on females with hemophilia, an inherited bleeding disorder. The study is designed to determine whether there are problems and issues unique to females with hemophilia.

Clinical Details

Official title: Females With Severe or Moderate Hemophilia A or B: an International Multi-center Study

Study design: Observational Model: Cohort, Time Perspective: Retrospective

Primary outcome: The molecular and cytogenetic etiology of the condition will be compiled. Clinical manifestation demonstrated by the female hemophiliacs will be compared to published data available. Genotype and phenotype will be correlated.

Detailed description: The study involves two questionnaires: one on the diagnosis, symptoms, complications and treatment of each participant to be completed by a staff member; the other is a questionnaire to be completed by the participant on how the disease has affected her life. Finally, for those participants who have not previously had genetic testing, the third part of the study is an optional blood test to determine the genetic cause, what change in the factor VIII or factor IX gene, caused the hemophilia. The test results will be available to those participants who wish to learn their results. With the data we collect we will compile a database to examine the connection between the genetic cause of hemophilia and the course and symptoms of the disease.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Females with severe (FVIII<0. 01u/ml) or moderate (FVIII 0. 01≤0. 05 u/ml) hemophilia A

- Females with severe (FIX<0. 01u/ml) or moderate (FIX 0. 01≤0. 05u/ml) hemophilia B

- Willingness to participate in the study.

Exclusion Criteria:

- Subjects who do not meet the inclusion criteria with respect to gender or hemophilia

severity.

Locations and Contacts

Princess Margaret Hospital for Children, Perth, Australia

University Clinic Bonn, Bonn, Germany

University Clinic Munich, Munich, Germany

Sheba Medical Center, Tel Hashomer, Israel

Instituto G. Gaslini, Genova, Italy

A. Bianchi Bonomi Hemophilia Center, Milan, Italy

Nara Medical University, Nara, Japan

University Hospital Utrecht, Utrecht, Netherlands

Malmo University Hospital, Malmo, Sweden

Changhua Christian Hospital, Chunghua City, Changhua, Taiwan

Weill Cornell Medical College, New York, New York 10065, United States

Additional Information

Starting date: March 2008
Last updated: December 6, 2012

Page last updated: August 20, 2015

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