BAX 855 Dose-Escalation Safety Study
- Conditions
- Hemophilia A
- Registration Number
- NCT01599819
- Lead Sponsor
- Baxalta now part of Shire
- Brief Summary
The objectives of this study are to assess the tolerability and safety after single dose treatments of BAX 855 in previously treated patients (PTPs) with severe hemophilia A, to determine the pharmacokinetic (PK) parameters of BAX 855 compared in crossover with ADVATE, and to evaluate the impact of anti-polyethylene glycol (PEG) antibodies on PK parameters.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 19
- The subject is male and is 18 to 65 years of age at the time of screening
- The subject has severe hemophilia A (factor VIII level < 1%)
- The subject was previously treated with plasma-derived factor VIII (FVIII) concentrates or recombinant FVIII for at least 150 exposure days (EDs)
- The subject has a detectable FVIII inhibitor at screening, with a titer >= 0.6 BU
- The subject has a documented history of FVIII inhibitors with a titer >= 0.4 BU at any time prior to screening
- The subject has a known hypersensitivity towards mouse or hamster proteins or to polyethylene glycol (PEG)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Serious and non-serious AEs 4 weeks after infusion with BAX 855 and ADVATE
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (8)
Specialized Hospital for Active Treatment "Joan Pavel"
🇧🇬Sofia, Bulgaria
Vivantes Klinikum im Friedrichshain, Hemophilia Care Center for Children and Adults
🇩🇪Berlin, Germany
UKGM Uniklinikum Giessen & Marburg
🇩🇪Giessen, Germany
Harrison Clinical Research Deutschland
🇩🇪Munich, Germany
Nara Medical University Hospital
🇯🇵Nara, Japan
Tokyo Medical University Hospital
🇯🇵Tokyo, Japan
Quintiles Drug Research Unit at Guy´s Hospital
🇬🇧London, United Kingdom
Manchester Haemophilia Comprehensive Care Centre, Manchester Royal Infirmary
🇬🇧Manchester, United Kingdom
Specialized Hospital for Active Treatment "Joan Pavel"🇧🇬Sofia, Bulgaria