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BAY14-2222 Continuous Infusion in Surgeries

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ClinicalTrials.gov Identifier: NCT00606060
Recruitment Status : Completed
First Posted : February 1, 2008
Last Update Posted : April 13, 2010
Sponsor:
Information provided by:
Bayer

Study Description
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Brief Summary:
Phase III study, to evaluate the efficacy and safety of continuous infusion of rFVIII-FS in the treatment of patients with hemophilia A undergoing major elective surgery by achieving the required therapeutic concentrations.

Condition or disease Intervention/treatment Phase
Hemophilia Drug: Kogenate (BAY14-2222) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Continuous Infusion of Recombinant Factor VIII - Sucrose-formulated (BAY 14 2222) Concentrate in Patients With Hemophilia A Undergoing Major Elective Surgery.
Study Start Date : July 2004
Actual Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemophilia

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1 Drug: Kogenate (BAY14-2222)
100 IU/mL (250 IU/vial nominal potency) continuous infusion over 6-11 days in 12 patients. 400 IU/mL (1000 IU/vial nominal potency) continuous infusion over 6-11days in 3 patients.


Outcome Measures
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Primary Outcome Measures :
  1. efficacy of continuous infusion of recombinant Factor VIII - sucrose-formulated (rFVIII-FS) in the treatment of patients with hemophilia A [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Evaluate the safety of rFVIII-FS. [ Time Frame: 28 days ]

Eligibility Criteria
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Ages Eligible for Study:   12 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Severe hemophilia A (FVIII:C </=1%)
  • No history of FVIII inhibitor formation and no current evidence of inhibitor antibody (Bethesda Assay < 0.6 BU)
  • Elective major surgery requiring at least 6 days of rFVIII-FS therapy
  • Subjects should have been previously treated with FVIII concentrates for at least 150 exposure days. Previous treatment could have been with any type of rFVIII or with plasma-derived FVIII concentrate or cryoprecipitate

Exclusion Criteria:

  • Abnormal renal function (serum creatinine >1.3 mg/dL)
  • Any treatments, which may change the clearance of FVIII (dialysis, plasma exchange)
  • Anemia (hemoglobin <11 g/dL)
  • Known AIDS (HIV seropositive patients may be enrolled)
  • Active liver disease (transaminases > 5 times the upper limit of normal)
  • History of severe reaction to FVIII concentrates
  • Interferon treatment within the last 3 months
  • Thrombocytopenia (< 100,000 platelets/mm3) or other known hematological/bleeding problems other than hemophilia A
  • Intake of other investigational drugs within 1 month prior to study entry
  • Need for pre-medication for FVIII infusions (e.g. antihistamines)
  • Diastolic blood pressure >100 mm/Hg, which could not be controlled with antihypertensive medications
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00606060


Locations
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Israel
Tel Hashomer, Israel, 52621
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
More Information
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Responsible Party: Therapeutic Area Head, Bayer HealthCare AG
ClinicalTrials.gov Identifier: NCT00606060    
Other Study ID Numbers: 11486
First Posted: February 1, 2008    Key Record Dates
Last Update Posted: April 13, 2010
Last Verified: April 2010
Keywords provided by Bayer:
Hemophilia,
Continuous Infusion
Additional relevant MeSH terms:
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Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
 Hemorrhagic Disorders
Genetic Diseases, Inborn
Factor VIII
Coagulants