BAY14-2222 Continuous Infusion in Surgeries

• ClinicalTrials.gov Identifier: NCT00606060
• Recruitment Status: Completed
• First Posted: February 1, 2008
• Last Update Posted: April 13, 2010
• Sponsor: Bayer
• Information provided by: Bayer

Tracking Information

• First Submitted Date: January 21, 2008
• First Posted Date: February 1, 2008
• Last Update Posted Date: April 13, 2010
• Study Start Date: July 2004
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: March 4, 2009): efficacy of continuous infusion of recombinant Factor VIII - sucrose-formulated (rFVIII-FS) in the treatment of patients with hemophilia A [ Time Frame: 28 days ]
• Original Primary Outcome Measures (submitted: January 31, 2008): Evaluate the efficacy of continuous infusion of recombinant Factor VIII - sucrose-formulated (rFVIII-FS) in the treatment of patients with hemophilia A undergoing major elective surgery by achieving the required therapeutic concentrations. [ Time Frame: 28 days ]
• Current Secondary Outcome Measures (submitted: January 31, 2008): Evaluate the safety of rFVIII-FS. [ Time Frame: 28 days ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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.
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Hemophilia

Intervention

Drug: 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.

Study Arms

Experimental: Arm 1

Intervention: Drug: Kogenate (BAY14-2222)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 31, 2008): 15
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: May 2005
• Primary Completion Date: Not Provided

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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 12 Years to 65 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Israel

Administrative Information

• NCT Number: NCT00606060
• Other Study ID Numbers: 11486
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Therapeutic Area Head, Bayer HealthCare AG
• Study Sponsor: Bayer
• Collaborators: Not Provided

Investigators

• Study Director: Bayer Study Director; Bayer

• PRS Account: Bayer
• Verification Date: April 2010