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

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

Official Title
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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

Conditions
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Hemophilia A

Intervention / Treatment
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* Drug: Antihemophilic factor, recombinant, manufactured protein-free


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 5 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Antihemophilic factor, recombinant, manufactured protein-free|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of participants experiencing treatment-related adverse experiences (AEs) |  | Throughout the study period of approximately 3.5 years |