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

Hemophilia A Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00157105
• Other study ID #: 069902
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: February 12, 2001
• Est. completion date: August 3, 2004

Study information

• Verified date: August 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: August 3, 2004
• Est. primary completion date: August 3, 2004
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 5 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemophilia A

Intervention

Drug:
• Antihemophilic factor, recombinant, manufactured protein-free

Locations

Country	Name	City	State
United States	Children´s Healthcare of Atlanta Blood Bank	Atlanta	Georgia
United States	Brigham and Women´s Hospital, Hematology Division	Boston	Massachusetts
United States	Children´s Hospital Medical Center Pharmacy, Hemophilia Treatment Center	Cincinnati	Ohio
United States	Michigan State University	East Lansing	Michigan
United States	Indiana Hemophilia & Thrombosis Center	Indianapolis	Indiana
United States	University of Iowa Hospitals and Clinics, Iowa Regional Hemophilia Center, Department of Pediatrics	Iowa City	Iowa
United States	Children´s Hospital Los Angeles, Hemophilia Comprehensive Care Center, Division of Pediatric Hematology/Oncology	Los Angeles	California
United States	Mt. Sinai Medical School, Hemophilia Comprehensive Care Center	New York	New York
United States	Hemophilia Center of Western Pennsylvania	Pittsburgh	Pennsylvania
United States	Puget Sound Blood Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Baxalta now part of Shire

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of participants experiencing treatment-related adverse experiences (AEs)		Throughout the study period of approximately 3.5 years