?Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method (rAHF?PFM): A Phase 3/4, prospective, controlled, randomized, multi-center Study to compare the efficacy and safety of continous infusion (CI) versus intermittent bolus infusion (BI) in subjects With Severe Or Moderately Severe Hemophilia A undergoing unilateral primary total knee replacement? - Advate Randomized Surgery Study
- Conditions
- Patients suffering from severe to moderately severe Haemophilia A (basal level of factor VIII < 2% of normal) undergoing Primary Total Unilateral Substitution of the Knee.MedDRA version: 9.1Level: LLTClassification code 10061992Term: Haemophilia
- Registration Number
- EUCTR2005-005697-71-IT
- Lead Sponsor
- Baxter Innovations GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
1.The subject or subject?s legally authorized representative has provided signed informed consent 2.The subject is within 18 to 70 years of age, 3. The subject is suffering from severe to moderately severe Haemophilia A (basal level of factor VIII ≤2% of normal) at screenig.A subgroup of 15 subjects in each group will show a basal level of factor VIII <1% of normal. 4.The aPTT must be within the range of normal after administration of F VIII concentrate, ad determined in the preoperative pharmacokinetic evaluation, or as documented in the medical history, if available. 5 The subject is scheduled to undergo an elective unilateral primary total knee replacement (with cemented or uncemented prothesis) 6. The subject has a documented history of at least 150 exposure days to factor VIII concentrates, before entering the study. 6.HIV positive subjects must be immunocompetent as determined with a CD4 count≥ 400 cells/mm³ (CD4 at screening), but HIV negative subjects with CD count <400 qualify, if immunocompetency is documented. 8. The subject has a life expectancy of at least 28 days from the day of surgery
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) yes
F.1.3.1 Number of subjects for this age range
1. The subject has an history of factor VIII inhibitors or a detectable factor VIII inhibitors at screening with a titer ≥ 0,4 BU; 2.The subject has an history of factor VIII inhibitors with a titer ≥ 0,4 BU(by Nijmegen assay)or ≥0,5 BU (by Bethesda assay)at any time prior to screening 3. The subject is scheduled to undergo any other current minor or major surgery during the course of the study.The placement of a central venous lines and the performance of fine needle aspiration biopsies are permitted; 4.Excluding hemophilia-related physical impairments, the subject is assigned to NYHA≥III according to New York Heart Association classification. 5. The subject with an abnormal renal function (serum creatinine >1.5mg/dL), 6. an active hepatic disease( [ALT]or [AST] levels >5 times the upper limit of normal), 7. a severe chronic liver disease (as evidenced by but not limited to INR >1.4, hypoalbuminemia,portal vein hypertansion, including presence of otherwise unexplained splenomegaly and history of esophageal varices, 9.The subject is currently receiving or scheduled to receive an immunomodulating drug other than antiretroviral chemotherapy; 10.a known hypersensitivity to mouse or hampster proteins. 11.The subject has received another investigational drug within 30 days prior to the screening and /or is scheduled to recieve additional investigational drug during the course of the trial in the context of another investigational drug study. 12.The subject is identified by the investigator as being unable or unwilling to cooperate with the study procedures.
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