Dettagli per singolo studio

DEC-NET Serial number ES354

Published online	23/02/2005 10.37.00
Last updated	28/03/2006 13.54.10

Other protocol ID number	ADV0401
Current trial status	Open (actively recruiting new participants)
Major Disease (ICD9 class)	CONGENITAL DEFICIENCY OF OTHER CLOTTING FACTORS
Experimental drug
Coagulation factor VIII (rAHF-PFM) Treatment regimen (dosage and duration) Initial phase: bolus 40 +/- 10UI per kg every 48 hours 12 days. After adjusted doses according to pharmacokinetic parameters
Gender	Both
Age (range)	< 18 years old
Eligibility criteria
Inclusion criteria
Severe or moderately severe hemophilia A patients (basal level of factor VIII < o = 2%) previously treated (previously treated with other concentrated factor VIII for at least 50 days)
Exclusion criteria
Patients with an inhibitor of factor VIII (known previously or detected when they are selected), known hypersensitivity to r-AHF, blood coagulation disorders other than hemophilia A, platelet count <100.000 /mm3, hemoglobin <10g/dL, renal dysfunction or bilirrubin more than twice the upper normal level for age.
Trial design/methodology
Phase	3
Kind of study	Efficacy Prophylaxis Safety Pharmacokinetics
Design
Purpose of study
To assess the eficacy and safety of one prophylactic and individualised treatment based on pharmacokinetic parameters, and to analyse the rAHF-PFM pharmacokinetics and immunogenicity in patients with severe or moderately severe hemophilia A previously treated.


Secondary outcomes
Pharmacokinetic parameters Efficacy: Number of hemorrhagic episodes and number of bolus of rAHF-PFM that they need Number of hemorrhagic episodes with good, acceptable and null response, and doses that is needed in every case Toxicity: Percentage of patients that present an adverse reaction because of the treatment Percentage of patients that develop inhibitors