BAX 802 in Congenital Haemophilia A with Inhibitors
Research type
Research Study
Full title
A Phase 3, Multicenter, Single-arm, Open-label Study of the Efficacy and Safety of B-Domain Deleted Recombinant Porcine Factor VIII (BAX 802) in Subjects with Congenital Hemophilia A with Factor VIII Inhibitors Undergoing Surgical or Other Invasive Procedures
IRAS ID
203652
Contact name
Pratima Chowdary
Contact email
Sponsor organisation
Baxalta Innovations GmbH
Eudract number
2015-005521-39
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
This study is being carried out to look at an investigational drug called BAX 802 in the treatment of male patients with hereditary haemophilia A who are undergoing certain major and minor planned surgical, dental, or “invasive procedures”. Invasive procedures are those in which the body is "invaded" or entered by a needle, tube, device, or scope for the purposes of investigating someone’s health.
This study aims to look at how well and how safely the study drug can control blood loss during such procedures. This study will involve at least 10 male patients of 18‒65 years of age who, in total, are undergoing at least 10 major and/or minor surgical, dental, or other invasive procedures. A minimum of 5 of the patients enrolled will be planning to undergo major surgery. This generally refers to
major orthopaedic (e.g., joint replacement), major abdominal, intracranial, cardiovascular,spinal and any other surgery which has a significant risk of large volume blood loss(> 500 mL) or blood loss into a confined anatomical space.
The study is divided into five periods: screening, pre-operative, intra-operative, post-operative, and end of study.The length of time the participant spends in the study will vary according to the type of surgery/procedure he has. He can be in the study for up to 14 weeks.
The dose of the study drug and how often the participant will receive it will be determined by the study doctor and will depend on the type of procedure the participant is planning to have, his weight, and the number of blood cells and level of inhibitors in his blood.
During each period of the study, the study doctor will perform some assessments to check his health and the list of assessments for each period are shown in the ICF.
The safety analysis set (SAS) will be comprised of all subjects who received any amount of BAX 802. The full analysis set (FAS) will be comprised of all surgeries with at least 1 available haemostatic assessment.REC name
London - Bloomsbury Research Ethics Committee
REC reference
16/LO/0718
Date of REC Opinion
20 Jun 2016
REC opinion
Further Information Favourable Opinion