A Study of the Efficacy and Safety of Drug BAX 802 in Subjects with Congenital Hemophilia A with Factor VIII Inhibitors Undergoing Surgical or Other Invasive Procedures

Phase 1

• Conditions: Congenital Haemophilia A with Factor VIII Inhibitors; MedDRA version: 20.0Level: LLTClassification code 10053751Term: Hemophilia A with anti factor VIIISystem Organ Class: 100000004850; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2015-005521-39-NL
• Lead Sponsor: Baxalta Innovations GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-05
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

1.Subject requires a major or minor elective surgical, dental or other invasive procedure
2 Subject is male and = 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 = 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.
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. The subject requires emergency surgery
2.Severe chronic liver dysfunction or disease eg, = 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 lboaratory at screening
4. Anti-porcine 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 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 intravascualr 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: Interventional clinical trial of medicinal product
• Study Design: Not specified