Phase 3b Continuation Study of the Safety and Efficacy of Prophylactic BAX 855 in PTPs With Severe Hemophilia A



Status:Completed
Conditions:Anemia, Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:Any - 75
Updated:11/30/2018
Start Date:October 15, 2013
End Date:March 2, 2018

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A Phase 3b Continuation Study of the Safety and Efficacy of PEGylated Recombinant Factor VIII (PEG-rFVIII; BAX 855) in Prophylaxis of Bleeding in Previously Treated Patients With Severe Hemophilia A

To continue the evaluation of the safety and efficacy of prophylaxis with BAX 855 for the
prevention and treatment of bleeding episodes in previously treated patients (PTPs) (children
and adults from 0 to 75 years of age) with severe hemophilia A.


Main Inclusion Criteria:

- Participants from other BAX 855 studies can be provided with the continuation study
informed consent form (ICF) prior to the end of study visit to review and consider
participation in this continuation study. These participants will complete any
additional screening assessments within 2 weeks of the previous study's end of study
visit and will return to the study site within 6 weeks of the previous study end of
study visit to confirm eligibility for this continuation study.

- BAX 855 naïve participants who are ≥ 12 years of age can only be enrolled in this
continuation study after enrollment in the phase 2/3 pivotal study is closed. BAX 855
naïve participants who are < 12 years of age and in countries where the pediatric PTP
study is being conducted can only be enrolled in this continuation study after
enrollment in the pediatric PTP study is closed.

- Participants coming from other BAX 855 studies into the continuation study, will be
considered enrolled only after they have completed all procedures and assessments at
the End of Study Visit in the previous BAX 855 study

- Participant and/or legal representative has/have voluntarily provided signed informed
consent

- Participant is from 0 to 75 years of age at screening

- Participant is male with severe hemophilia A (Factor VIII (FVIII) clotting activity <
1%) as confirmed by central laboratory at screening (after at least a 72-hour washout
period) or a documented FVIII clotting activity <1% (confirmation is only required for
BAX 855 naïve participants)

- Participant has been previously treated with plasma-derived FVIII concentrates or
recombinant FVIII for ≥150 documented exposure days (EDs)

- Participant is currently receiving prophylaxis or on-demand therapy with FVIII

- Participant has a Karnofsky or Lansky performance score of ≥ 60.

- 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.

- Participant is willing and able to comply with the requirements of the protocol

Main Exclusion Criteria:

- Participant has detectable FVIII inhibitory antibodies (≥ 0.4 Bethesda unit (BU) using
the Nijmegen modification of the Bethesda assay) as confirmed by central laboratory at
screening.

- Participant has history of FVIII inhibitory antibodies (≥ 0.4 BU using the Nijmegen
modification of the Bethesda assay or ≥ 0.6 BU using the Bethesda assay) at any time
prior to screening.

- Participant has been diagnosed with an inherited or acquired hemostatic defect other
than hemophilia A (eg, qualitative platelet defect or von Willebrand's disease).

- Participant has known hypersensitivity towards mouse or hamster proteins, polyethylene
glycol (PEG), or Tween 80.

- Participant has severe chronic hepatic dysfunction.

- Participant has severe renal impairment.

- Participant has current or recent (<30 days) use of other PEGylated drugs prior to
study participation or scheduled use of such drugs during study participation.

- Participant has participated in another clinical study involving an investigational
product (IP) other than BAX 855 or device 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.

- Participant has medical, psychiatric, or cognitive illness or recreational
drug/alcohol use that, in the opinion of the investigator, would affect participant
safety or compliance.

- Participant is a family member or employee of the investigator.
We found this trial at
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
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Chapel Hill, North Carolina 27599
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
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700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
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740 South Limestone Street
Lexington, Kentucky 40536
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Adelaide, South Australia
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Aurora, Colorado 80045
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225 E Chicago Ave
Chicago, Illinois 60611
(312) 227-4000
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
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5 Richland Medical Park Dr
Columbia, South Carolina 29203
(803) 434-7000
Palmetto Health Richland Palmetto Health Richland, originally founded in 1892 as Columbia Hospital, has a...
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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3450 Hull Road
Gainesville, Florida 32610
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Hershey, Pennsylvania 17033
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Kansas City, Missouri 64108
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
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New Hyde Park, New York 11040
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New Orleans, Louisiana 70112
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1100 N. Lindsay
Oklahoma City, Oklahoma 73104
(405) 271-4000
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1919 E Thomas Rd
Phoenix, Arizona 85006
(602) 933-1000
Phoenix Children's Hospital Phoenix Children's Hospital has provided hope, healing, and the best healthcare for...
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Seattle, Washington 98133
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