Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
PHASE3
8 participants
INTERVENTIONAL
2016-12-22
2021-01-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BAX 802 in Surgery
Participants who are undergoing major or minor elective surgical, dental, or other invasive procedures.
Antihemophilic Factor (Recombinant), Porcine Sequence (BAX 802)
In case of major surgery, FVIII target level is ≥80% for major surgeries/ procedures and ≥50% for minor surgeries/ procedures.
Interventions
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Antihemophilic Factor (Recombinant), Porcine Sequence (BAX 802)
In case of major surgery, FVIII target level is ≥80% for major surgeries/ procedures and ≥50% for minor surgeries/ procedures.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Participant is male and ≥ 12 to ≤ 75 years old at the time of screening
3. Participant has provided signed informed consent (and assent for adolescent participants, as applicable) in accordance with local regulatory requirements
4. Participant has severe (factor VIII (FVIII) level \< 1%) or moderately severe (FVIII level ≤ 2%) congenital hemophilia A (CHA) with inhibitors to human factor VIII (hFVIII) of ≥ 0.6 Bethesda units (BU), as tested at screening at the central laboratory
5. Participant is not currently receiving or has recently received (\< 30 days) immune tolerance induction (ITI) therapy
6. Participant has a Karnofsky performance score of ≥ 60 at screening
7. Participant is human immunodeficiency virus negative (HIV-); or HIV+ with stable disease and CD4+ count ≥ 200 cells/mm\^3 at screening
8. Participant 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. Participant is willing and able to comply with the requirements of the protocol.
Exclusion Criteria
2. Severe chronic liver dysfunction or disease (e.g., ≥ 5 × 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 laboratory at screening
4. Anti-porcine factor VIII (pFVIII) inhibitor \> 10 BU prior to surgery
5. Platelet count \< 100,000/μL at screening
6. Participant has another active coagulation disorder, other than hemophilia A, as per the medical history
7. Planned use of α-interferon with or without ribavirin 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 recombinant porcine factor VIII (rpFVIII), or hamster or murine proteins
9. Participant has an ongoing or recent (within 3 months of screening) thrombo-embolic disease, fibrinolysis or disseminated intravascular coagulation (DIC)
10. Participant has been exposed to an IP within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an investigational product (IP) or investigational device during the course of this study
11. Participant is unable to tolerate quantity of blood to be drawn for protocol procedures
12. Participant is a family member or employee of the Investigator.
12 Years
75 Years
MALE
No
Sponsors
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Baxalta Innovations GmbH, now part of Shire
INDUSTRY
Baxalta now part of Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Shire
Locations
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Bleeding and Clotting Disorders Institute
Peoria, Illinois, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States
Case Western Reserve University
Cleveland, Ohio, United States
UMHAT 'Tsaritsa Yoanna - ISUL', EAD
Sofia, , Bulgaria
UMHATEM 'N.I. Pirogov', EAD
Sofia, , Bulgaria
Hopital Maisonneuve-Rosemont d/b/a CIUSSS de l'Est-de-l'Île-de-Montréal
Montreal, Quebec, Canada
Universitaetsklinikum Bonn AoeR
Bonn, , Germany
Zentrum für Hämostaseologie, Universitätsklinikum Leipzig AöR
Leipzig, , Germany
Presidio Ospedaliero di Castelfranco Veneto
Castelfranco Veneto, Treviso, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, , Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, , Italy
Azienda Ospedaliera di Padova
Padua, , Italy
UMC Utrecht
Utrecht, , Netherlands
Oslo Universitetssykehus - Rikshospitalet
Oslo, , Norway
Instytut Hematologii i Transfuzjologii-1-1Y7-1347
Warsaw, , Poland
FSBI of Science "Kirov Scientific and Research Institute of Hematology and Blood Transfusion of FMBA.
Kirov, , Russia
Bleeding Disorders Unit and Clinical Haematology Service at Charlotte Maxeke JHB Academic Hospital
Johannesburg, , South Africa
Hospital Universitari i Politecnic La Fe
Valencia, Valencia, Spain
Complejo Hospitalario Universitario A Coruña
A Coruña, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Ankara University Medical Faculty
Ankara, , Turkey (Türkiye)
Ege University Medical Faculty
Izmir, , Turkey (Türkiye)
Ege University Medical Faculty
Izmir, , Turkey (Türkiye)
Kocaeli University Medical Faculty
Kocaeli, , Turkey (Türkiye)
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain more information on the study, click here/on this link
Other Identifiers
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2015-005521-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
241502
Identifier Type: -
Identifier Source: org_study_id