Study Completed

Hemophilia

Bayer Identifier:

11486

ClinicalTrials.gov Identifier:

NCT00606060

EudraCT Number:

Not Available

EU CT Number:

Not Available

BAY14-2222 Continuous Infusion in Surgeries

Trial 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.

Key Participants Requirements

Sex

Male

Age

12 - 65 Years

Inclusion Criteria
- Severe hemophilia A (FVIII:C - 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, plasmaexchange)
- 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

Trial summary

Enrollment Goal

Trial Dates

July 2004 - May 2005

Phase

Phase 3

Could I Receive a placebo

Products

Kogenate FS (Recombinant Factor VIII, BAY14-2222)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	Chaim Sheba Medical Center	Tel Hashomer, 52621, Israel

Primary Outcome

efficacy of continuous infusion of recombinant Factor VIII - sucrose-formulated (rFVIII-FS) in the treatment of patients with hemophilia A
Time Frame:
28 days
Safety Issue:
yes

Secondary Outcome

Evaluate the safety of rFVIII-FS.
Time Frame:
28 days
Safety Issue:
yes

Trial design

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.

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

Non-randomized

Blinding

Open Label

Assignment

Single Group Assignment

Trial Arms

Additional Information

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