BAY14-2222 Continuous Infusion in Surgeries - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00606060

Purpose

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 III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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:

Genetics Home Reference related topics: hemophilia

MedlinePlus related topics: Hemophilia Surgery

Drug Information available for: Octocog alfa Moroctocog Alfa Factor VIII

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Evaluate the safety of rFVIII-FS. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Enrollment:	15
Study Start Date:	July 2004
Study Completion Date:	May 2005

Arms	Assigned Interventions
Arm 1: Experimental	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.

Eligibility

Ages Eligible for Study:	12 Years to 65 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00606060

Locations

Israel

Tel Hashomer, Israel, 52621

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

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No publications provided

Responsible Party:	Bayer HealthCare AG ( Therapeutic Area Head )
Study ID Numbers:	11486
Study First Received:	January 21, 2008
Last Updated:	June 29, 2009
ClinicalTrials.gov Identifier:	NCT00606060 History of Changes
Health Authority:	Israel: Ethics Commission

Keywords provided by Bayer:

Hemophilia,
Continuous Infusion

Study placed in the following topic categories:

Hemorrhagic Disorders
Genetic Diseases, Inborn
Hematologic Diseases
Blood Coagulation Disorders

Hemophilia A
Hemostatic Disorders
Factor VIII

Additional relevant MeSH terms:

Hemorrhagic Disorders
Blood Coagulation Disorders, Inherited
Genetic Diseases, Inborn
Coagulation Protein Disorders

Hematologic Diseases
Blood Coagulation Disorders
Hemophilia A

ClinicalTrials.gov processed this record on September 03, 2009