A study for safety and effectiveness of blood clotting factor VIII (Bax 855) for patients with blood clotting disorder called Hemophilia A, undergoing surgeries.
- Conditions
- Severe hemophilia A (FVIII<1%)MedDRA version: 19.0Level: LLTClassification code 10060612Term: Hemophilia ASystem Organ Class: 100000004850Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2013-001359-11-BG
- Lead Sponsor
- Baxalta Innovations GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 40
Subject requires an elective major or minor surgical, dental or other invasive procedure (e.g. biopsy, endoscopy).
2. Subject and/or legal representative has/have provided signed informed consent.
3. Subject is 2 to 75 years of age at the time of enrollment.
4. Subject is male with severe hemophilia A (FVIII level <1%) as confirmed by the central lab at screening or a documented FVIII activity level <1%.
5. Subject was previously treated with FVIII concentrates with =150 documented exposure days (EDs).
6. Subject is currently receiving prophylaxis or on-demand therapy with FVIII concentrate.
7. Subject has a Karnofsky performance score of =60 at screening.
8. Subject is human immunodeficiency virus negative (HIV-); or HIV+ with stable disease and CD4+ count =200 cells/mm3, as confirmed by central laboratory at screening.
9. Subject is Hepatitis C virus negative (HCV-) by antibody or PCR testing, as confirmed by central laboratory at screening; or HCV+ with chronic stable hepatitis as assessed by the investigator. If positive, antibody titer will be confirmed by PCR.
10. Subject is willing and able to comply with the requirements of the study protocol.
11. For subjects transitioning from parent Bax855 studies, the subjects
contunies to meet the entry criteria.
Are the trial subjects under 18? yes
Number of subjects for this age range: 40
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
1. Subject has detectable FVIII inhibitory antibodies (=0.4 BU using the Nijmegen modification of the Bethesda assay) at screening as determined by the central laboratory or at any timepoint prior to screening (=0.4 BU using the Nijmegen modification of the Bethesda assay or =0.6 BU using the Bethesda assay).
2. History of ongoing or recent thrombotic disease, fibrinolysis or disseminated intravascular coagulation (DIC).
3. Subject has a platelet count <100 x 109/L, as confirmed by central laboratory at screening.
4. Subject has severe renal impairment (serum creatinine > 2.0 mg/dL), as confirmed by central laboratory at screening.
5. Subject has severe chronic hepatic dysfunction (eg =5 X upper limit of normal alanine aminotransferase (ALT), as confirmed by central laboratory at screening, or a documented INR > 1.5).
6. Subject has a known hypersensitivity towards mouse or hamster proteins, polysorbate 80 or to PEG.
7. Subject is currently using or has recently (< 30 days) used pegylated drugs (other than BAX855) prior to study participation or is scheduled to use such drugs during trial participation.
8. Subject is currently participating in another clinical drug (other than BAX855) or device study or use of another investigational product or device within 30 days prior to study entry.
9. Subject has a diagnosis of an inherited or acquired hemostatic defect other than hemophilia A.
10. Subject is currently receiving, or scheduled to receive during the course of the study, an immunomodulating drug (e.g., systemic corticosteroid agent at a dose equivalent to hydrocortisone greater than 10 mg/day, or alpha interferon) other than anti-retroviral chemotherapy.
11. Subject has a clinically significant medical, psychiatric, or cognitive illness, or recreational drug/alcohol use that, in the opinion of the investigator, would affect subject safety or compliance.
12. The subject has an incremental recovery <1.5 IU/dL:IU/kg as determined in the parent study, if applicable.
13. Subjects undergoing minor or major emergency surgery.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method