Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
The purpose of this study is to:
Full description
15 JUN 2020: The temporary enrollment stop of new patients into this study due to the COVID-19 pandemic has been lifted in one or more countries/sites, and the study is now again enrolling new patients. However, some countries/sites may still have paused the enrollment of new patients due to the pandemic.
23 APRIL 2020: Enrollment of new patients into this study has been paused due to the COVID-19 situation. The duration of this pause is dependent on the leveling and control of the COVID-19 pandemic.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Greater than or equal to (> or =) 18 to less than or equal to (< or =) 65 years old at the time of screening.
Hemophilia A or B of any severity, with a documented > or = 3 months history of inhibitors (> or = 0.6 Bethesda units [BU]) requiring the use of bypassing agents (FEIBA or rFVIIa) prior to screening. Inhibitor level will be tested at screening if no documented history is available.
Hepatitis C virus (HCV) negative, either by antibody testing or polymerase chain reaction (PCR); or HCV positive with stable liver disease.
Human immune deficiency virus (HIV) negative; or HIV positive with stable disease and CD4 count > or = 200 cells per cubic millimetre (cell/mm3) at screening.
Adequate venous access.
Willing and able to comply with the requirements of the protocol.
If a female of childbearing potential, must have a negative blood pregnancy test and agrees to employ adequate birth control measures for the duration of the study, such as: a. Abstain from sexual intercourse, b. Use a reliable method of contraception (contraception such as an intrauterine device, barrier method [e.g., diaphragm or sponge; female condom not permitted] with spermicide, oral contraceptive, injectable progesterone, sub dermal implant), and have their male partner use a condom
If female of non-childbearing potential, confirmed at screening by fulfilling 1 of the following criteria:
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
45 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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