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

Brief Title

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

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

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.

Study Phase

Phase 2/Phase 3

Study Type

Interventional

Primary Outcome

Percent of participants experiencing treatment-related adverse experiences (AEs)

Condition

Hemophilia A

Intervention

Antihemophilic factor, recombinant, manufactured protein-free

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

February 12, 2001

Completion Date

August 3, 2004

Primary Completion Date

August 3, 2004

Eligibility Criteria

        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.

Gender

Male

Ages

5 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Study Director, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT00157105

Organization ID

Responsible Party

Sponsor

Study Sponsor

Baxalta now part of Shire

Study Sponsor

Study Director, Study Director, Takeda

Verification Date

August 2021