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

Phase 3

Completed

• Conditions: Hemophilia A; bleeding disorder; 10035534; 10005330

• Registration Number: NL-OMON47364
• Lead Sponsor: Baxter

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 1

Inclusion Criteria

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
laboratory
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.

Exclusion Criteria

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.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified