- * Diagnosed with Haemophilia A with ≤ 1% Factor VIII (FVIII) levels in the absence of factor replacement
- * Evidence of vaccination against hepatitis A and B (or presence of antibodies against hepatitis A and B due to either a previous infection or prior immunisation) within 10 years prior to Day 1 documented in the medical notes
- * At least 150 days of prior exposure to a FVIII replacement product
- * Written informed consent given
- Exclusion Criteria (for participation in the pharmacokinetic (PK) component):
- * Active bleeding
- * Body weight \> 100 kg
- Exclusion Criteria (for all subjects):
- * Receipt of an infusion of any FVIII product, cryoprecipitate, whole blood, plasma, or desmopressin acetate (DDAVP) in the 4 days prior to Day 1
- * Known history of FVIII inhibitors, or FVIII inhibitor level \> 0.6 Bethesda Units (BU) at screening
- * Receipt of aspirin or other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) within 7 days of administration of study product.
- * CD4 lymphocytes \< 200/µL. Subjects wo are HIV-1 positive may be considered for the study if viral load ≤ 200 particles/µL at screening and all other eligibility criteria are met.
- * Impaired liver function ie. bilirubin \>1.5 x upper limit of normal (ULN) and/or AST/ALT \> 2.5 x ULN at screening.
- * Acute or chronic medical condition, other than haemophilia A, which may, in the opinion of the Investigator, affect the conduct of the study
- * von Willebrand Disease (VWD) with Von Willebrand Factor:Ristocetin Cofactor (vWF:RCo) level \< 50 IU/dL at screening
- * Evidence or a history (within the previous 12 months) of abuse of any drug substance, licit or illicit
- * Known or suspected hypersensitivity or previous evidence of severe side effects to Biostate®, FVIII concentrates or human albumin
- * Participation in a clinical study or use of an investigational compound (e.g. a new chemical entity not approved for clinical use) in the 3 months preceding the first day of study drug administration, or plans to enter such a study during the study period
- * Not willing and/or not able to comply with study requirements
Hemophilia A
Study of a pd vWF/FVIII, Biostate®, in Subjects With Haemophilia A
NCT00879541 | PHASE 2 | INTERVENTIONAL
The aim of this study are to * assess the efficacy of Biostate® \[Study Product (SP)\] in subjects with Haemophilia A * compare the pharmacokinetics of Biostate® \[SP\] with the previously marketed product Biostate® (here referred to as Biostate® \[Reference Product (RP)\]). This study is divided into 3 parts: Part 1: Cross-over pharmacokinetic (PK) component. PK subjects will be randomised to determine the order in which they receive the two study products. This part of the study is double-blinded. Part 2: Efficacy component. All subjects will receive Biostate® \[SP\] as required to manage their haemophilia condition for an estimated period of 6 months (or minimum of 50 exposure days) to assess efficacy and safety of the product. This part of the study is open-label. Part 3: Repeat pharmacokinetic assessment. Subjects who participated in Part 1 (PK component) will undergo a repeat PK assessment on Day 180 following administration of Biostate® \[SP\].
Trial Information
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Study Site
Plovdiv,Bulgaria
Study Site
Sofia,Bulgaria
Study Site
Varna,Bulgaria
Study Site
Skopje,Macedonia, The Former Yugoslav Republic of
Study Site
Bialystok,Poland
Study Site
Gdansk,Poland
Study Site
Krakow,Poland
Study Site
Lublin,Poland
Study Site
Poznan,Poland
Study Site
Warszawa,Poland
Study Site
Wroclaw,Poland
Study Site
Barnaul,Russian Federation
Study Site
Kirov,Russian Federation
Study Site
Moscow,Russian Federation
Study Eligibility Criteria
Additional Studies
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