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

NCT00936312 | Completed

• 1 other identifier: Intl Female Hemophilia Study
• Study Type: observational
• Target: 200
• Locations: 9 countries
• Sites: 11

Brief 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.

Conditions

Hemophilia A; Hemophilia B

Outcome Measures

Primary Outcomes (1)

• 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.

  1-2 visits

Study Arms (2)

Females with Hemophilia

Females with severe or moderate Hemophilia A or B

Control group

Male subjects with severe Hemophilia A or B and female subjects with mild (20-60%) Hemophilia A or B.

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Females with severe or moderate Hemophilia A (less than or equal to 5%) Females with severe or moderate Hemophilia B (less than or equal to 5%)

You may qualify if:

• 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.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Bayer: collaborator
• University Hospital, Bonn: collaborator

Study Sites (11)

Weill Cornell Medical College

New York, New York, 10065, United States

Location

Princess Margaret Hospital for Children

Perth, Australia

Location

University Clinic Bonn

Bonn, Germany

Location

University Clinic Munich

Munich, Germany

Location

Sheba Medical Center

Tel Litwinsky, Israel

Location

Instituto G. Gaslini

Genova, Italy

Location

A. Bianchi Bonomi Hemophilia Center

Milan, Italy

Location

Nara Medical University

Nara, Japan

Location

University Hospital Utrecht

Utrecht, Netherlands

Location

Malmo University Hospital

Malmo, Sweden

Location

Changhua Christian Hospital

Chunghua City, Changhua, Taiwan

Location

MeSH Terms

Conditions

Hemophilia A; Hemophilia B

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, X-Linked

Study Officials

• William B Mitchell, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2009
• First Posted: July 10, 2009
• Study Start: March 1, 2008
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: December 10, 2012

Record last verified: 2012-12

Locations

AU (1); DE (2); IL (1); JP (1); NL (1); SE (1); TW (1); IT (2); US (1)