EUCTR2015-005521-39-PLActive, not recruitingPhase 1
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 - BAX802 in Congenital Hemophilia A with Inhibitors
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Baxalta Innovations GmbH
- Enrollment
- 12
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Male
Inclusion Criteria
- •1.Subject requires elective , dental or other invasive procedures
- •2. Subject is male and = 12 to = 75 years old at the time of screening
- •2. 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 laboratory
- •5. Subject is not currently receiving or has recently 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
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 2
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 9
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
Exclusion Criteria
- •1.1. The subject requires emergency surgery
- •2. Severe chronic liver dysfunction or disease (e.g., = 5 x upper limit of normal [ULN] alanine aminotransferase [ALT], as confirmed by central
- •laboratory at screening or a documented prothrombin time/international
- •normalized ratio [PT/INR] > 1.5)
- •3. Clinically symptomatic renal disease (serum creatinine > 2.0 mg/dL),
- •as confirmed by central laboratory at screening
- •4. Anti-pFVIII inhibitor > 10 BU prior to surgery
- •5. Platelet count < 100,000/µL at screening
- •6. Subject has another active coagulation disorder other than
- •haemophilia A, as per the medical history
- •7. 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
- •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.
Investigators
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