Phase 3 Haemophilia Trial, Completed

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

For people already in a BAX 855 study who are moving into this trial:

• The person has completed their final visit in a previous BAX 855 study, or is currently in the Baxalta Continuation Study 261302.
• The person is currently using BAX 855 either to treat bleeds as they happen or to prevent bleeds, and has had 2 or more documented and treated bleeds in the past 12 months.
• The person is HIV-negative, or if HIV-positive, has a stable condition and a CD4+ immune cell count of at least 200 cells/mm³, confirmed by a central laboratory.
• The person is willing and able to follow the study requirements.

For newly enrolled people (including those who have never used BAX 855):

• The person has severe haemophilia A, confirmed by a very low level of clotting factor VIII (less than 1% activity), either by laboratory testing or historical records from a certified medical laboratory.
• The person has previously been treated with a factor VIII product (either plasma-derived or laboratory-made) on at least 150 separate occasions.
• The person is currently using treatment either to stop bleeds as they happen or to prevent bleeds, and has had 2 or more documented and treated bleeds in the past 12 months.
• The person scores at least 60 on the Karnofsky performance scale at screening, meaning they are able to carry out normal activity with only minor limitations (confirm with trial site).
• The person is HIV-negative, or if HIV-positive, has a stable condition and a CD4+ immune cell count of at least 200 cells/mm³, confirmed by a central laboratory.
• The person is hepatitis C (HCV) negative, confirmed by antibody testing at a central laboratory, or if HCV-positive, has a chronic but stable form of the disease.
• Women who could become pregnant must have a negative pregnancy test at the start of the study and must agree to use reliable contraception throughout.
• The person is willing and able to follow the study requirements.

Who may not be able to join:

For people already in a BAX 855 study who are moving into this trial:

• The person has developed confirmed antibodies that work against factor VIII (called inhibitors), at a level of 0.6 BU or higher, detected during their previous BAX 855 study.
• The person has been diagnosed with a blood clotting disorder other than haemophilia A.
• The person weighs less than 35 kg or more than 100 kg.
• The person has a platelet (blood cell) count below 100,000/mL.
• The person has abnormal kidney function, with a specific blood marker (serum creatinine) more than 1.5 times the upper limit of normal.
• The person has active liver disease, with liver enzyme levels (ALT and/or AST) 5 or more times the upper limit of normal.
• The person is planned to receive certain immune-suppressing medications during the study (such as higher-dose corticosteroids or alpha-interferon), other than anti-HIV medicines.
• The person has a significant medical, mental health, or cognitive condition, or substance or alcohol use issues that, in the investigator's opinion, could affect their safety or ability to follow the study.
• The person plans to take part in any other clinical trial at the same time.
• The person is a member of the study team, or has a close personal or employment relationship with someone on the study team (such as a family member or employee of the investigator).

For newly enrolled people (including those who have never used BAX 855):

• The person currently has detectable factor VIII inhibitor antibodies at a level of 0.6 BU or higher, confirmed by a central laboratory at screening.
• The person has a history of confirmed factor VIII inhibitors at a level of 0.6 BU or higher at any point before the screening visit.
• The person has been diagnosed with any other inherited or acquired blood clotting disorder in addition to haemophilia A (for example, a platelet disorder or von Willebrand disease).
• The person weighs less than 35 kg or more than 100 kg.
• The person has a platelet count below 100,000/mL.
• The person has a known allergic sensitivity to mouse or hamster proteins, PEG, or Tween 80 (substances used in the study drug).
• The person has severe chronic liver disease, indicated by liver enzyme levels (ALT and/or AST) 5 or more times the upper limit of normal, or a blood clotting measure (INR) above 1.5.
• The person has severe kidney impairment, with serum creatinine more than 1.5 times the upper limit of normal.
• The person is currently using, or has used within the past 30 days, another medication that contains PEG (a type of chemical coating), or is planned to use one during the study.
• The person is planned to receive certain immune-suppressing medications during the study (such as higher-dose corticosteroids or alpha-interferon), other than anti-HIV medicines.
• The person has taken part in another clinical trial involving an investigational treatment or device within the past 30 days, or is planned to do so during this study.
• The person has a medical, mental health, or cognitive condition, or substance or alcohol use issues that, in the investigator's opinion, could affect their safety or ability to follow the study.
• The person is a member of the study team, or has a close personal or employment relationship with someone on the study team (such as a family member or employee of the investigator).

Important: Always verify eligibility with the trial site directly before applying.