Hemophilia A
Conditions
Interventions
Trade Name: ReFacto
Product Name: REFACTO
Product Code: 3082
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: moroctocog alfa
CAS Number: 284036/24/4
Current S
Sponsors
Wyeth Pharmaceuticals, Global Medical Affairs
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Documented history of severe hemophilia A (FVIII:C =1%)· Previously treated patients (PTP) with at least 150 exposure days to any factor VIII product(s) Male aged =18 years and less than 65 years ALT and AST =5 x ULN, and bilirubin =2mg/dL Serum creatinine =1.25 x ULN Platelet count >100,000/µL Absolute CD4 count =200/mL Prothrombin time =1.25 x ULN Serum albumin = LLN Signed and dated informed consent 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: Known hypersensitivity to any recombinant factor VIII product or murine/hamster allergen History of or current FVIII inhibitor, defined as = 0.6 BU or >ULN as defined at the local lab (whichever is lower). Surgery within 30 days prior to Period 1, Day 1 or surgery planned during the study The occurrence of a bleeding episode requiring FVIII replacement therapy within 3 days prior to Period 1, Day 1 (screening failure) Factor VIII treatment within 3 days (72 hours) prior to Period 1, Day 1 (screening failure) or Period 2, Day 1. Treatment with any investigational drug or device within the past 30 days with the exception of ReFacto, ReFacto AF or Advate. Patients who are currently on Highly Active Anti-Retroviral Therapy (HAART) are excluded. Unwillingness to agree to the washout period or other terms of the protocol The presence of any condition that, in the investigator’s opinion, makes participation in the study not advisable (eg, frequent bleeding episodes that preclude a subject from abiding by the 3-day washout, poor venous access resulting in the inability to provide adequate pharmacokinetic sampling)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary: To compare the pharmacokinetic parameters of ReFacto and Advate, using the chromogenic substrate assay to measure FVIII:C.;Secondary Objective: ;Primary end point(s): Area under the plasma FVIII:C versus time curve for 48 hours | — |
Countries
Germany, United Kingdom
Outcome results
None listed