Dettagli per singolo studio

DEC-NET Serial number ES466

Published online	12/09/2005 15.06.00
Last updated	24/04/2006 10.09.50

Other protocol ID number	3090A1-302-WW
Current trial status	Complete(closed to recruitment of participants: follow-up complete)
Major Disease (ICD9 class)	CONGENITAL FACTOR IX DISORDER
Gender	Both
Age (range)	> or = 12 years old
Eligibility criteria
Inclusion criteria
12 years old patients or older, with moderate-severe hemophilia B (level of activity of FIX in plasma [FIX:C] < or = 2%), with at least 150 days of exposition of any product of FLX, and able to follow the proceedings of the study (in the investigator's opinion); it is also necessary the patient, parent or legal tutor to have signed volontary the informed consent before the procedures of screening.
Exclusion criteria
Some level of FIX inhibitor (or history of), defined as > 0,6 UB. Known hypersensitivity to drugs composed mainly by proteins or to agents related with the studied agent, i.e. proteins of hamster. Abnormal liver function (defined as < 2,5 the upper normal level of ALT, AST and/or total bilirubin), abnormal renal function (plasmatic creatinin > 1,2 the upper normal level), low level of albumin, platelet <100.000 mm3, abnormal prothrombin time (>1,25 the upper normal range), CD4 < 400/mcl, other genetic blood disorders (excepting the vitamin K deficiency of the newborn), treatment with any investigational drug during the previous 30 days, and other.
Trial design/methodology
Phase	3
Kind of study	Efficacy Prophylaxis Safety Pharmacokinetics
Design
Purpose of study
The main objective is to assess the safety and efficacy of rFIX during at least 6 months in PTP with hemophilia B (FIX:C < or = 2%) on standard treatment (on-demand, prophylaxis and during major and minor surgery).
Primary outcomes
Saffety and efficacy of rFIX during at least 6 month in PTP with hemophilia B (FIX:C < o = 2%)used the standar treatment (on-demand regime, prophylactic or for surgery).
Secondary outcomes
1. Parameters FK and FD single in patients after unique, and any change of this parameters after several exposition of rFIX. 2.-Describe the inmunogenicity/newantigenicity of rFIX in PTP using study of development of inhibitor anti-FIX (BIA, development of anti-FIX antibodies (ELISA).Trombogenicity ; haemorrhage/no effect, allergic reactions; hematies aglutination. 3.Saffety and efficacy of rFIX in CI during major surgery. 4. FK of single rFIX for determinate de dosage in CI use.
Summary of study design, objectives, and ongoing research findings
This is an open-label, multinational and not randomized study about the treatment of patients of at least 12 years old, with hemophilia B (FIX:C < or = 2%), previously exposed to FIX (>150 days), and who will be treated with a standard regimen of rFIX. If they are eligible, they will receive the first dose of rFIX (75 IU/kg) in the center of pharmacokinetic analysis and several blood samples will be obtained during a period of 72 hours. Patients will be treated (on demand or as prophylaxis) for a minimum period of 6 months. In order to guarantee an appropriate assessment of immunogenicity/antigenicity, patients will be on treatment during a maximum of 1 year. If a surgical intervention is necessary, the tratment will be adjusted. If some allergic symptom appears, the possibility to participate in the C9907-21 Protocol will be offered (this is an study designed to assess the etiology of allergic symptoms during the treatment with BeneFIX.