BAY14-2222 Continuous Infusion in Surgeries

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00606060
First received: January 21, 2008
Last updated: April 12, 2010
Last verified: April 2010
  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.


Condition Intervention Phase
Hemophilia
Drug: Kogenate (BAY14-2222)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • efficacy of continuous infusion of recombinant Factor VIII - sucrose-formulated (rFVIII-FS) in the treatment of patients with hemophilia A [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluate the safety of rFVIII-FS. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Enrollment: 15
Study Start Date: July 2004
Study Completion Date: May 2005
Arms Assigned Interventions
Experimental: Arm 1 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.

  Eligibility

Ages Eligible for Study:   12 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00606060

Locations
Israel
Tel Hashomer, Israel, 52621
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Therapeutic Area Head, Bayer HealthCare AG
ClinicalTrials.gov Identifier: NCT00606060     History of Changes
Other Study ID Numbers: 11486
Study First Received: January 21, 2008
Last Updated: April 12, 2010
Health Authority: Israel: Ethics Commission

Keywords provided by Bayer:
Hemophilia,
Continuous Infusion

ClinicalTrials.gov processed this record on October 19, 2014