Antihemophilic Factor (Recombinant) Plasma/Albumin-Free Method (rAHF PFM): A Phase 4, Prospective, Controlled, Randomized, Multi-Center Study to Compare the Efficacy and Safety of Continuous 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
- Conditions
- Subjects with severe or moderately severe hemophilia A (residual factor VIII activity =2%) undergoing unilateral primary total knee replacementMedDRA version: 9.1Level: LLTClassification code 10060612Term: Hemophilia A
- Registration Number
- EUCTR2005-005697-71-GB
- Lead Sponsor
- Baxter AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 72
1. The subject or the subject’s legally authorized representative has provided signed informed consent.
2. The subject is within 18 to 65 years of age.
3. The subject has severe or moderately severe hemophilia A, defined by a baseline factor VIII level = 2% of normal, as tested at screening. A subset of 15 subjects per group must have baseline factor VIII levels <1% of normal.
4. The subject is scheduled to undergo an elective unilateral primary total knee replacement (with cemented or uncemented prosthesis).
5. The subject was previously treated with factor VIII concentrate(s) for a minimum of at least 150 exposure days (as estimated by the investigator) prior to study entry.
6. Human immunodeficiency virus (HIV) positive subjects must be immunocompetent as determined with a CD4 count = 400 cells/mm³ (CD4 count at screening).
7. 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) no
F.1.3.1 Number of subjects for this age range
1. The subject has a detectable factor VIII inhibitor at screening, with a titer = 0.4 BU (Nijmegen modification of the Bethesda Assay) in the central laboratory.
2. The subject has a history of factor VIII inhibitors with a titer ³ 0.4 BU (by Bethesda or Nijmegen assay) at any time prior to screening.
3. The subject is scheduled to undergo any other concurrent minor or major surgery during the course of the study. The placement of central venous lines is permitted.
4. The subject has an abnormal renal function (serum creatinine > 1.5 mg/dL).
5. The subject has active hepatic disease (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] levels > 5 times the upper limit of normal).
6. The subject has severe chronic liver disease as evidenced by, but not limited to, any of the following: International Normalized Ratio (INR) > 1.4, hypoalbuminemia, portal vein hypertension including presence of otherwise unexplained splenomegaly and history of esophageal varices.
7. The subject has clinical and/or laboratory evidence of abnormal hemostasis from causes other than hemophilia A (e.g., late-stage chronic liver disease, immune thrombocytopenia purpura).
8. The subject is currently receiving, or is scheduled to receive during the course of the study, an immunomodulating drug other than anti-retroviral chemotherapy (e.g., a-interferon, corticosteroid agents at a dose equivalent to hydrocortisone greater than 10 mg/day).
9. The subject has a known hypersensitivity to mouse or hamster proteins.
10. The subject is participating in another investigational drug study within 30 days prior to screening.
11. The subject is identified by the investigator as being unable or unwilling to cooperate with 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