A Randomised, Two-way, Blinded, Crossover-Design Study to Establish the Bioequivalence of B-Domain Deleted Recombinant Factor VIII (BDDrFVIII, ReFacto AF) with a Full-Length Recombinant Factor VIII Preparation (FLrFVIII, Advate), Followed by an Open-Label Trial of the Safety and Efficacy of ReFacto AF in Previously Treated Patients with Hemophilia A
- Conditions
- For all patients participating in the trial:Male subjects with severe or moderately severe hemophilia A (FVIII:C = 2%) previously treated with = 150 exposure days to any Factor VIII product.For patients participating in the Pharmacokinetic period of the trial:Male subjects as described immediately above except they must have a Factor VIII:C of = 1%
- Registration Number
- EUCTR2005-000720-16-HU
- Lead Sponsor
- Wyeth Research Division of Wyeth Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 100
For all patients participating in the trial:- Male subjects with severe or moderately severe hemophilia A (FVIII:C = 2%) previously treated with = 150 exposure days to any Factor VIII product. - Age = 12 years- ALT (SGOT) and AST (SGPT) =5.0 x ULN, and bilirubin =2mg/dL (33 µmol/L)- Serum albumin = LLN- Serum creatinine =1.25 x ULN- Platelet count = 100,000 /µL- Absolute CD4 count >400 µL- PT =1.25 x ULN or INR = 1.5- Patients receiving therapy for HIV or Hepatitis infection, must be on a stable regimen at the time of study entry- The patient is able to comply with the mandatory 72-hour washout period preceding each FVIII:C and FVIII inhibitor assessment during Visit 1, 4, 5, 7 and 10- The patient must sign and date informed consent and/or assent form, approved by the IRB.The Global Medical Monitor should be consulted about prospective subjects with complex clinical or laboratory histories relevant to inclusion criteriaFor patients participating in the pharmacokinetic period of the trial:- Male subjects as described immediately above except they must have a Factor VIII:C of = 1% confrimed by the central laboratory screening test- The patient’s site has the facilities, in the opinion of the Sponsor, adequate to conduct the Pharmacokinetic analysis- The patient should be able to comply with the mandatory 72 hour washout period preceding each PK period of the study during Visit 2, 3 and 10.
Are the trial subjects under 18? yes
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) yes
F.1.3.1 Number of subjects for this age range
A history of FVIII inhibitor (clinical or laboratory based assessment, as defined in the protocol definitions), such as recurrent low titer values. Any measured Bethesda inhibitor titer greater than or equal to 0.6 BU/mL, regardless of the laboratory normal range, or any measured Bethesda inhibitor titer greater than the upper limit of normal for the laboratory performing the assay- Presence of a bleeding disorder in addition to hemophilia A- Treatment with any investigational drug or device within the past 30 days - Elective surgery planned to occur within an 8 to 9 month period following study entry (i.e., during the course of the study)- Regular (e.g. daily, QOD) use of antifibrinolytic agents or medications known to influence platelet function such as aspirin or certain NSAIDs- Concomitant therapy with immunosuppressive drugs (e.g., IVIG, routine systemic corticosteroids) ·- Known hypersensitivity to hamster protein·Unwilling or unable to follow the terms of the protocol- The Global Medical Monitor should be consulted about prospective subjects with complex clinical or laboratory histories relevant to exclusion criteria
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method