BAY14-2222 Continuous Infusion in Surgeries

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Hemophilia

Intervention / Treatment
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* Drug: Kogenate (BAY14-2222)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Kogenate (BAY14-2222)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy of continuous infusion of recombinant Factor VIII - sucrose-formulated (rFVIII-FS) in the treatment of patients with hemophilia A |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the safety of rFVIII-FS. |  | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemophilia,, Continuous Infusion