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BAY14-2222 Continuous Infusion in Surgeries

This study has been completed.
Information provided by:
Bayer Identifier:
First received: January 21, 2008
Last updated: April 12, 2010
Last verified: April 2010
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 Intervention Phase
Hemophilia Drug: Kogenate (BAY14-2222) Phase 3

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:

Further study details as provided by Bayer:

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

Enrollment: 15
Study Start Date: July 2004
Study Completion Date: May 2005
Arms Assigned Interventions
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.


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

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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Please refer to this study by its identifier: NCT00606060

Tel Hashomer, Israel, 52621
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Therapeutic Area Head, Bayer HealthCare AG Identifier: NCT00606060     History of Changes
Other Study ID Numbers: 11486
Study First Received: January 21, 2008
Last Updated: April 12, 2010

Keywords provided by Bayer:
Continuous Infusion

Additional relevant MeSH terms:
Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Factor VIII
Coagulants processed this record on August 23, 2017