Safety and Efficacy Study of a Recombinant and Protein-Free Factor VIII (rAHF-PFM) in Hemophilia A Patients Undergoing Surgery

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. Identifier: NCT00157105
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : October 23, 2017
Information provided by:

Brief Summary:
The purpose of this study is to evaluate whether rAHF-PFM is safe and effective in the treatment of hemophilia A patients undergoing surgery.

Condition or disease Intervention/treatment Phase
Hemophilia A Drug: Antihemophilic factor, recombinant, manufactured protein-free Not Applicable

Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Recombinant Antihemophilic Factor (rAHF PFM) Manufactured and Formulated Without Added Human or Animal Proteins: Evaluation of Safety and Efficacy in Hemophilia A Patients Undergoing Surgical or Invasive Procedures
Study Start Date : February 2001
Study Completion Date : August 2004

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:   5 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age >= 5 years
  • The subject has severe or moderately severe hemophilia A defined by a baseline factor VIII level <= 2% of normal documented at screening or historically (e.g., at hemophilia diagnosis)
  • Subjects may enroll regardless of their serologic status for human immunodeficiency virus (HIV-1) and hepatitis C virus (HCV)
  • The subject requires a surgical, dental or other invasive procedure--either elective or emergency
  • The subject has a history of at least 150 exposure days for all other factor VIII products (as estimated by the study site investigator) prior to study entry
  • The subject has a life expectancy of at least 28 days from the day of surgery
  • The subject has been informed of the nature of the study, agreed to its provisions, and signed and dated the informed consent form approved by the appropriate IRB/IEC and Baxter BioScience

Exclusion Criteria:

  • The subject has a detectable inhibitor to factor VIII in the local hemostasis laboratory at the investigative site at the time of enrollment
  • The subject has a history of inhibitor to factor VIII > 1.0 BU. Note: If the subject has a history of an inhibitor titer > 1.0 BU at any time prior to enrollment but demonstrated expected clinical responses to conventional doses of factor VIII therapy, the subject may enroll
  • The subject has known hypersensitivity to Recombinate
  • The subject is currently participating in another investigational drug study, or has participated in any clinical trial involving an investigational drug within 30 days of study entry
  • The subject has clinical and/or laboratory evidence of abnormal hemostasis from causes other than hemophilia A (e.g., late-stage chronic liver disease, immune thrombocytopenic purpura, disseminated intravascular coagulation)
  • The subject is identified by the investigator as being unable or unwilling to cooperate with study procedures.

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 identifier (NCT number): NCT00157105

United States, California
Children´s Hospital Los Angeles, Hemophilia Comprehensive Care Center, Division of Pediatric Hematology/Oncology
Los Angeles, California, United States, 90027
United States, Georgia
Children´s Healthcare of Atlanta Blood Bank
Atlanta, Georgia, United States, 30322
United States, Indiana
Indiana Hemophilia & Thrombosis Center
Indianapolis, Indiana, United States, 46260
United States, Iowa
University of Iowa Hospitals and Clinics, Iowa Regional Hemophilia Center, Department of Pediatrics
Iowa City, Iowa, United States, 52242
United States, Massachusetts
Brigham and Women´s Hospital, Hematology Division
Boston, Massachusetts, United States, 02115
United States, Michigan
Michigan State University
East Lansing, Michigan, United States, 48824
United States, New York
Mt. Sinai Medical School, Hemophilia Comprehensive Care Center
New York, New York, United States, 10029
United States, Ohio
Children´s Hospital Medical Center Pharmacy, Hemophilia Treatment Center
Cincinnati, Ohio, United States, 45229
United States, Pennsylvania
Hemophilia Center of Western Pennsylvania
Pittsburgh, Pennsylvania, United States, 15213-4306
United States, Washington
Puget Sound Blood Center
Seattle, Washington, United States, 98104-1256
Sponsors and Collaborators
Baxalta now part of Shire
Principal Investigator: Amy Shapiro, MD Indiana Hemophilia & Thrombosis Center

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00157105     History of Changes
Other Study ID Numbers: 069902
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: October 23, 2017
Last Verified: October 2006

Additional relevant MeSH terms:
Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Factor VIII