BAY14-2222 Continuous Infusion in Surgeries

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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00606060

Enrollment

Registered

2008-02-01

Start date

2004-07-31

Completion date

2005-05-31

Last updated

2010-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemophilia

Keywords

Hemophilia,, Continuous Infusion

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.

Interventions

DRUGKogenate (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 design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

12 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
efficacy of continuous infusion of recombinant Factor VIII - sucrose-formulated (rFVIII-FS) in the treatment of patients with hemophilia A	28 days

Secondary

Measure	Time frame
Evaluate the safety of rFVIII-FS.	28 days

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026