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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 Continuous Infusion (CI) Versus Intermittent Bolus Infusion (BI) in Subjects With Severe or Moderately Severe Hemophilia A Undergoing Major Orthopedic Surgery


Phase 4
18 Years
70 Years
Open (Enrolling)
Both
Hemophilia A

Thank you

Trial Information

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 Continuous Infusion (CI) Versus Intermittent Bolus Infusion (BI) in Subjects With Severe or Moderately Severe Hemophilia A Undergoing Major Orthopedic Surgery


Inclusion Criteria:



- The subject or the subject's legally authorized representative has provided signed
informed consent.

- The subject is within 18 to 70 years of age.

- 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.

- The aPTT must be within the range of normal after administration of FVIII
concentrate, as determined in the preoperative pharmacokinetic evaluation, or as
documented in the medical history, if available.

- The subject is scheduled to undergo an elective unilateral major orthopedic surgery
that requires drain placement.

- 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.

- Human immunodeficiency virus (HIV) positive subjects must be immunocompetent as
determined with a CD4 count >= 200 cells/mm³ (CD4 count at screening), but HIV
negative subjects with a CD4 count < 200 cells/mm³ qualify, if immunocompetency is
documented.

- The subject has a life expectancy of at least 28 days from the day of surgery.

Exclusion Criteria:

- 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.

- The subject has a 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.

- 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 and the
performance of fine needle aspiration biopsies are permitted.

- Excluding hemophilia-related physical impairments, the subject is assigned to NYHA
class >= III according to the New York Heart Association (NYHA).

- The subject has an abnormal renal function (serum creatinine > 1.5 mg/dL).

- The subject has active hepatic disease (alanine aminotransferase [ALT] or aspartate
aminotransferase [AST] levels > 5 times the upper limit of normal).

- 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.

- 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).

- 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.,
alpha-interferon, corticosteroid agents at a dose equivalent to hydrocortisone
greater than 10 mg/day).

- The subject has a known hypersensitivity to mouse or hamster proteins.

- The subject has received another investigational drug study within 30 days prior to
screening and/or is scheduled to receive additional investigational drug during the
course of the trial in the context of another investigational study.

- The subject is identified by the investigator as being unable or unwilling to
cooperate with study procedures.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Comparison of the cumulative packed red blood cell (PRBC) volume in the drainage fluid during 24 hours following surgery in subjects receiving rAHF-PFM by bolus infusion or continuous infusion

Outcome Time Frame:

24 hours following surgery

Safety Issue:

No

Principal Investigator

Isabella Presch, MD

Investigator Role:

Study Director

Investigator Affiliation:

Baxter Healthcare Corporation

Authority:

Austria: Federal Ministry for Health and Women

Study ID:

060402

NCT ID:

NCT00357656

Start Date:

June 2006

Completion Date:

August 2016

Related Keywords:

  • Hemophilia A
  • Hemophilia A (severe or moderately severe)
  • Hemophilia A

Name

Location

James Graham Brown Cancer CenterLouisville, Kentucky  40202
University Hospitals of ClevelandCleveland, Ohio  44106
Georgetown UniversityWashington, District of Columbia  20007-2197
Penn State Milton S. Hershey Medical CenterHershey, Pennsylvania  17033
Rush Presbyterian St. LukesChicago, Illinois  60612
Tulane UniversityNew Orleans, Louisiana  70112-2699
Johns Hopkins Medical InstitutionsBaltimore, Maryland  21205
Los Angeles Orthopaedic HospitalLos Angeles, California  90007
Brigham and Women´s HospitalBoston, Massachusetts  02115
The University of Texas Health Science Center at Houston Medical SchoolHouston, Texas  77030