Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

BAY14-2222 Continuous Infusion in Surgeries

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00606060
Recruitment Status : Completed
First Posted : February 1, 2008
Last Update Posted : April 13, 2010
Sponsor:
Information provided by:
Bayer

Tracking Information
First Submitted Date  ICMJE January 21, 2008
First Posted Date  ICMJE February 1, 2008
Last Update Posted Date April 13, 2010
Study Start Date  ICMJE July 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2008)
Evaluate the safety of rFVIII-FS. [ Time Frame: 28 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE BAY14-2222 Continuous Infusion in Surgeries
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hemophilia
Intervention  ICMJE 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  ICMJE Experimental: Arm 1
Intervention: Drug: Kogenate (BAY14-2222)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 31, 2008)
15
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 12 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00606060
Other Study ID Numbers  ICMJE 11486
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Therapeutic Area Head, Bayer HealthCare AG
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP