HEREDITARY HAEMOPHILIA B One single pharmacokinetic to compare the pharmacokinetic profile of BeneFIX with that of AlphaNine used by the same patients in a previous trial. MedDRA version: 9.1 Level: LLT Classification code 10018939 Term: Haemophilia B (Factor IX)
Conditions
Interventions
Trade Name: BENEFIX®
Product Name: Benefix
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Nonacog alfa
Concentration unit: IU/kg international unit(s)/kilogram
Sponsors
Grifols Biologicals Inc.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: • patients having participated in the previous study “Efficacy and safety of factor IX (FIX) contained in ALPHANINE® in patients with severe hereditary haemophilia B” Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients will be deemed ineligible if they: • have received a dose of FIX in the 7 days previous to the infusion • have a FIX inhibitor level of >0.5 Bethesda units or clinically relevant presence in the past (>5 BU), • have active bleeding at that moment of infusion, • CD4 lymphocyte count 1.5 mg/dl), • have documented liver cirrhosis or any hepatic disorder with ALT levels 2.5 times or more than the normal upper limit, • are simultaneously participating in other clinical studies, • prevision to be concomitantly treated with other FIX-containing products, • have conditions that might affect patient compliance (survival-limiting [in 2 year time] diseases, alcohol or other drug abuse, etc.), • any patient unable to provide a storage plasma sample before the first dose of Benefix®.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To compare AlphaNine® with BeneFIX® in terms of theirtioned pharmacokinetic profile. Pharmacokinetic parameters of FIX: in vivo recovery, half-life, area under the curve (AUC), mean residence time (MRT) and clearance, in at least 15 patients. ;Secondary Objective: Safety Immunogenicity Clinical safety (thrombogenicity and tolerance to infusion) Viral safety (HIV, HCV). ;Primary end point(s): Efficacy variables: FIX:C activity before and at different times after infusion of FIX concentrate. Consumption of FIX (IU/kg) Achievement of haemostasis Requirements of other blood derivative products Loss of blood in surgery Safety Variables: FIX inhibitor status Thrombogenicity markers: prothrombin fragments 1+2 (F1+2), thrombin-antithrombin complex (TAT) and d-dimer Changes in vital signs and occurrence of adverse events Seroconversions (HIV, HCV) | — |
Countries
Bulgaria
Outcome results
None listed