A Phase 3, Multicenter, Single-arm, Open-label Study of the Efficacy and Safety of B-Domain Deleted Recombinant Porcine Factor VIII (BAX 802) in Subjects with Congenital Hemophilia A with Factor VIII Inhibitors Undergoing Surgical or Other Invasive Procedures - BAX 802 in Congenital Hemophilia A with Inhibitors

Baxter0 个研究点目标入组 1 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

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•1. Subject requires a major or minor elective surgical, dental or other invasive procedure.
•2. Subject is male * 12 to * 75 years old at the time of screening
•3. Subject has provided signed informed consent (and assent for adolescent subjects, as applicable) in accordance with local regulatory requirements
•4. Subject has severe (FVIII level < 1%) or moderately severe (FVIII level * 2%)
•CHA with inhibitors to hfVIII of * 0.6 BU, as tested at screening at the central
•5. Subject is not currently receiving or has received (< 30 days) ITI therapy
•6. Subject has a Karnofsky performance score of * 60 at screening
•7. Subject is human immunodeficiency virus negative (HIV-); or HIV+ with stable
•disease and CD4+ count * 200 cells/mm3 at screening
•8. Subject is hepatitis C virus negative (HCV-) by antibody or polymerase chain
•reaction (PCR) testing; or HCV+ with chronic stable hepatitis disease. Positive serologies will be confirmed by PCR testing.
•9. Subject is willing and able to comply with the requirements of the protocol.

•1. The subject requires emergency surgery
•2. Severe chronic liver dysfunction or disease (eg, * 5 X upper limit of normal (ULN) alaine aminotransferase (ALT), as confirmed by central laboratory at screening or a documented prothrombin time/international normalized ration (PT/INR) >1.5)
•3. Clinically symptomatic renal disease (serum creatinine > 2.0 mg/dl), as confirmed by central laboratory at screening
•4. Anti-porcine inhibitor > 10 BU prior to surgery
•5. Platelet count < 100,000/*L at screening
•6. Subject has another active coagulation disorder other than hemophilia A, as per
•the medical history
•7. Planned use of *-interferon with or without ribavarin for HCV infected patients or
•planned use of a protease inhibitor for HIV infected patients. Patients currently
•taking any of these medications for * 30 days are eligible
•8. Known hypersensitivity to rpFVIII, or hamster or murine proteins
•9. Subject has an ongoing or recent (within 3 months of screening) thrombo-embolic disease, fibrinolysis, or disseminated intravascular coagulation (DIC)
•10. Subject has been exposed to an IP within 30 days prior to enrollment or is
•scheduled to participate in another clinical study involving an IP or
•investigational device during the course of this study
•11. Subject is unable to tolerate quantity of blood to be drawn for protocol procedures
•12. Subject is a family member or employee of the investigator.

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