Back to resultsBAY14-2222 Continuous Infusion in Surgeries
Primary Purpose
Hemophilia
Status
Completed
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
Kogenate (BAY14-2222)
Sponsored by
About this trial
This is an interventional treatment trial for Hemophilia focused on measuring Hemophilia,, Continuous Infusion
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm 1
Arm Description
Outcomes
Primary Outcome Measures
efficacy of continuous infusion of recombinant Factor VIII - sucrose-formulated (rFVIII-FS) in the treatment of patients with hemophilia A
Secondary Outcome Measures
Evaluate the safety of rFVIII-FS.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00606060
Brief Title
BAY14-2222 Continuous Infusion in Surgeries
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.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemophilia
Keywords
Hemophilia,, Continuous Infusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Kogenate (BAY14-2222)
Intervention Description
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.
Primary Outcome Measure Information:
Title
efficacy of continuous infusion of recombinant Factor VIII - sucrose-formulated (rFVIII-FS) in the treatment of patients with hemophilia A
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Evaluate the safety of rFVIII-FS.
Time Frame
28 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
BAY14-2222 Continuous Infusion in Surgeries
We'll reach out to this number within 24 hrs