Status:
COMPLETED
Phase 3 Efficacy and Safety Study of BAX 855 in Severe Hemophilia A Patients Undergoing Surgical Procedures
Lead Sponsor:
Baxalta now part of Shire
Conditions:
Hemophilia A
Eligibility:
MALE
12-65 years
Phase:
PHASE3
Brief Summary
The purpose of the study is to evaluate the efficacy and safety of BAX 855 in severe hemophilia A previously treated (PTP) males, 12 to 65 years of age who are undergoing elective surgical or other in...
Eligibility Criteria
Inclusion
- Participant requires an elective major or minor surgical, dental or other invasive procedure (e.g. biopsy, endoscopy).
- Participant and/or legal representative has/have provided signed informed consent.
- Participant has severe hemophilia A (Factor VIII (FVIII) level \<1%) as confirmed by the central lab at screening or a documented FVIII activity level \<1%.
- Participant was previously treated with FVIII concentrates with ≥150 documented exposure days (EDs).
- Participant is currently receiving prophylaxis or on-demand therapy with FVIII concentrate.
- Participant has a Karnofsky performance score of ≥60 at screening.
- Participant is human immunodeficiency virus negative (HIV-); or HIV+ with stable disease and CD4+ count ≥200 cells/mm\^3, as confirmed by central laboratory at screening.
- Participant is Hepatitis C virus negative (HCV-) by antibody or PCR testing (if positive, antibody titer will be confirmed by PCR), as confirmed by central laboratory at screening; or HCV+ with chronic stable hepatitis as assessed by the investigator.
- Participant is willing and able to comply with the requirements of the study protocol.
Exclusion
- Participant has detectable FVIII inhibitory antibodies (≥0.4 Bethesda Unit (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).
- History of ongoing or recent thrombotic disease, fibrinolysis or disseminated intravascular coagulation (DIC).
- Participant has a platelet count \<100 x 10\^9/L, as confirmed by central laboratory at screening.
- Participant has severe renal impairment (serum creatinine \> 2.0 mg/dL), as confirmed by central laboratory at screening.
- Participant has severe chronic hepatic dysfunction (eg ≥5 X upper limit of normal alanine aminotransferase (ALT), as confirmed by the central laboratory at screening, or a documented International Normalized Ratio (INR) \> 1.5).
- Participant has a known hypersensitivity towards mouse or hamster proteins, polysorbate 80 or to PEG.
- Participant is currently using or has recently (\< 30 days) used pegylated drugs (other than BAX 855) prior to study participation or is scheduled to use such drugs during trial participation.
- Participant is currently participating in another clinical drug (other than BAX 855) or device study or use of another investigational product or device within 30 days prior to study entry.
- Participant has a diagnosis of an inherited or acquired hemostatic defect other than hemophilia A.
- Participant is currently receiving, or scheduled to receive during the course of the study, an immunomodulating drug (eg, systemic corticosteroid agent at a dose equivalent to hydrocortisone \>10 mg/day, or alpha interferon) other than anti-retroviral chemotherapy.
- Participant has a clinically significant medical, psychiatric, or cognitive illness, or recreational drug/alcohol use that, in the opinion of the investigator, would affect participant safety or compliance.
Key Trial Info
Start Date :
December 20 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 23 2016
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01913405
Start Date
December 20 2013
End Date
September 23 2016
Last Update
May 24 2021
Active Locations (22)
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1
University of Florida College of Medicine
Gainesville, Florida, United States, 32610
2
Bleeding and Clotting Disorders Institute
Peoria, Illinois, United States, 61614
3
University of Louisville
Louisville, Kentucky, United States, 40202
4
Children's Mercy Hospitals & Clinics
Kansas City, Missouri, United States, 64108