Hemophilia A
Conditions
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.
Interventions
Sponsors
Baxalta now part of Shire
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
5 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent of participants experiencing treatment-related adverse experiences (AEs) | Throughout the study period of approximately 3.5 years |
Countries
United States
Outcome results
None listed