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

BAXALTA INNOVATIONS GMBH0 个研究点目标入组 8 人开始时间: 2020年2月4日最近更新: 2022年3月21日

试验速览

暂无简介。

•1. Subject is male and = 18 to = 65 years old at the time of screening
•2. Subject has provided signed informed consent
•3. Subject has severe (FVIII level < 1%) or moderately severe (FVIII level = 2%) CHA with inhibitors
•to human FVIII, as tested at screening at the central laboratory
•4. Subject requires elective surgery or other invasive procedures
•5. Subject is not currently receiving or has recently received (< 30 days) ITI therapy
•6. Subject has a Karnofsky performance score of = 60
•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
•9. Subject is willing and able to comply with the requirements of the protocol.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 1
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 14
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. The subject requires emergency surgery
•2. The subject’s weight is < 35 kg or > 120 kg
•3. Clinically symptomatic liver disease (eg, = 5 X upper limit of normal alanine aminotransferase
•[ALT], as confirmed by central laboratory at screening, clinical evidence of portal hypertension,
•severe hypoalbuminemia or a documented prothrombin time/international normalized ratio [PT/INR]
•4. Clinically symptomatic renal disease (serum creatinine > 2.0 mg/dL), as confirmed by central
•laboratory at screening
•5. Anti-porcine inhibitor > 10 Bethesda units (BU) prior to surgery
•6. Platelet count < 100,000/µL
•7. Subject has another active coagulation disorder, other than hemophilia A, as per the medical history
•8. Planned use of a-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
•9. Known hypersensitivity to rpFVIII, or hamster or murine proteins
•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. Unable to tolerate quantity of blood to be drawn for protocol procedures
•12. Subject is a family member or employee of the investigator

发起方