Phase 3 Efficacy and Safety Study of BAX 855 in Severe Hemophilia A Patients Undergoing Surgical Procedures



Status:Completed
Conditions:Anemia, Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:12 - 65
Updated:11/17/2018
Start Date:December 20, 2013
End Date:September 23, 2016

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A Phase 3, Multi-Center, Open Label Study of Efficacy and Safety of PEGylated rFVIII (BAX 855) in Previously Treated Patients With Severe Hemophilia A Undergoing Surgical or Other Invasive Procedures

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 invasive procedures.


Inclusion Criteria:

- 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 Criteria:

- 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.
We found this trial at
9
sites
3450 Hull Road
Gainesville, Florida 32610
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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Seattle, Washington 98104
(206) 543-2100
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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Kansas City, Missouri 64108
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
University of Louisville The University of Louisville is a state supported research university located in...
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Salt Lake City, Utah 84132
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