BAY14-2222 Continuous Infusion in Surgeries

NCT00606060 | Completed Phase 3

• 1 other identifier: 11486
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemophilia

Keywords

Hemophilia,; Continuous Infusion

Outcome Measures

Primary Outcomes (1)

• efficacy of continuous infusion of recombinant Factor VIII - sucrose-formulated (rFVIII-FS) in the treatment of patients with hemophilia A

  28 days

Secondary Outcomes (1)

• Evaluate the safety of rFVIII-FS.

  28 days

Study Arms (1)

Arm 1

EXPERIMENTAL

Drug: Kogenate (BAY14-2222)

Interventions

Kogenate (BAY14-2222) DRUG

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.

Arm 1

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Tel Litwinsky, 52621, Israel

Location

MeSH Terms

Conditions

Hemophilia A

Interventions

F8 protein, human; BAY 14-2222

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 21, 2008
• First Posted: February 1, 2008
• Study Start: July 1, 2004
• Study Completion: May 1, 2005
• Last Updated: April 13, 2010

Record last verified: 2010-04

Locations

IL (1)