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

Completed · Phase 3

Conditions studied: Hemophilia A

In brief

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.

Key facts

Study ID

NCT01913405

Run by

Baxalta now part of Shire

People needed

30

Starts

2013-12-20

Expected to finish

2016-09-23

Last updated by the study team

2021-05-24

Who can join

Age: 12 and older, up to 65. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Utah Health Sciences Center — Salt Lake City, Utah, United States
• University of Washington — Seattle, Washington, United States
• SHAT of Oncohaematology Diseases — Sofia, Bulgaria
• MHAT 'Sv. Marina', EAD — Varna, Bulgaria
• Vilnius University Hospital Santariskiu Clinics, Public Institution — Vilnius, Lithuania
• Academisch Medisch Centrum — Amsterdam, Netherlands
• FSHI "Kirov SR Institute of Hematology and Blood Transfusion FMBA" — Kirov, Russia
• Hospital Universitari Son Espases — Palma de Mallorca, Balearic Islands, Spain
• Complejo Hospitalario Universitario A Coruña — A Coruña, La Coruña, Spain
• Hospital Regional Universitario de Malaga — Málaga, Málaga, Spain
• Hospital Universitari i Politecnic La Fe — Valencia, Spain
• Universitaetsspital Zuerich — Zurich, Switzerland
• SI Institute of Blood Pathology and Transfusion Medicine of AMSU — Lviv, Ukraine
• Royal Free Hospital — London, Greater London, United Kingdom
• Great Ormond Street Hospital for Children — London, Greater London, United Kingdom
• Royal Manchester Children's Hospital — Manchester, Greater Manchester, United Kingdom
• University of Florida College of Medicine — Gainesville, Florida, United States
• Bleeding and Clotting Disorders Institute — Peoria, Illinois, United States
• University of Louisville — Louisville, Kentucky, United States
• Children's Mercy Hospitals & Clinics — Kansas City, Missouri, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States

Full record on ClinicalTrials.gov

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