BAY14-2222 Continuous Infusion in Surgeries

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2005-05-31

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.

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Detailed Description

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Conditions

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Hemophilia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Kogenate (BAY14-2222)

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

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

Minimum Eligible Age

12 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No