Status:
COMPLETED
Study of a pd vWF/FVIII, Biostate®, in Subjects With Haemophilia A
Lead Sponsor:
CSL Behring
Collaborating Sponsors:
Parexel
Conditions:
Hemophilia A
Eligibility:
MALE
12+ years
Phase:
PHASE2
Brief Summary
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 p...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT00879541
Start Date
February 1 2009
End Date
October 1 2010
Last Update
February 11 2011
Active Locations (14)
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1
Study Site
Plovdiv, Bulgaria
2
Study Site
Sofia, Bulgaria
3
Study Site
Varna, Bulgaria
4
Study Site
Skopje, North Macedonia