BAX 802 in CHA With Inhibitors

Stopped early · Phase 3

Conditions studied: Hemophilia A

In brief

The purpose of this study is to evaluate the efficacy and safety of BAX 802 in males with congenital hemophilia A (CHA) with inhibitors who are undergoing major or minor elective surgical, dental, or other invasive procedures.

Key facts

Study ID

NCT02895945

Run by

Baxalta now part of Shire

People needed

8

Starts

2016-12-22

Expected to finish

2021-01-22

Last updated by the study team

2021-10-20

Who can join

Age: 12 and older, up to 75. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Participant requires a major or minor elective surgical, dental or other invasive procedure
• Participant is male and ≥ 12 to ≤ 75 years old at the time of screening
• Participant has provided signed informed consent (and assent for adolescent participants, as applicable) in accordance with local regulatory requirements
• 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
• Participant is not currently receiving or has recently received (< 30 days) immune tolerance induction (ITI) therapy
• 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 at screening
• 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.
• Participant is willing and able to comply with the requirements of the protocol.

You may not qualify if…

• The participant requires emergency surgery
• 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)
• Clinically symptomatic renal disease (serum creatinine > 2.0 mg/dL), as confirmed by central laboratory at screening
• Anti-porcine factor VIII (pFVIII) inhibitor > 10 BU prior to surgery
• Platelet count < 100,000/μL at screening
• Participant has another active coagulation disorder, other than hemophilia A, as per the medical history
• 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
• Known hypersensitivity to recombinant porcine factor VIII (rpFVIII), or hamster or murine proteins
• Participant has an ongoing or recent (within 3 months of screening) thrombo-embolic disease, fibrinolysis or disseminated intravascular coagulation (DIC)
• 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
• Participant is unable to tolerate quantity of blood to be drawn for protocol procedures
• Participant is a family member or employee of the Investigator.

Where it is running

• 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 — Padova, 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)

Full record on ClinicalTrials.gov

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