check_circleStudy 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
  • - 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

  • - 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
15
Trial Dates
July 2004 - May 2005
Phase
Phase 3
Could I Receive a placebo
No
Products
Kogenate FS (Recombinant Factor VIII, BAY14-2222)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Chaim Sheba Medical CenterTel 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
    date_rangeTime Frame:
    28 days
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    Safety Issue:
    yes

Secondary Outcome

  • Evaluate the safety of rFVIII-FS.
    date_rangeTime Frame:
    28 days
    enhanced_encryption
    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
1

Additional Information

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