BAY14-2222 Continuous Infusion in Surgeries

Hemophilia Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00606060
• Other study ID #: 11486
• Status: Completed
• Phase: Phase 3
• First received: January 21, 2008
• Last updated: April 12, 2010
• Start date: July 2004
• Est. completion date: May 2005

Study information

• Verified date: April 2010
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 12 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Hemophilia
• Hemophilia A

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	efficacy of continuous infusion of recombinant Factor VIII - sucrose-formulated (rFVIII-FS) in the treatment of patients with hemophilia A		28 days	Yes
Secondary	Evaluate the safety of rFVIII-FS.		28 days	Yes

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