BAY14-2222 Continuous Infusion in Surgeries

April 12, 2010 updated by: Bayer

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel Hashomer, Israel, 52621

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluate the safety of rFVIII-FS.
Time Frame: 28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Study Completion (Actual)

May 1, 2005

Study Registration Dates

First Submitted

January 21, 2008

First Submitted That Met QC Criteria

January 31, 2008

First Posted (Estimate)

February 1, 2008

Study Record Updates

Last Update Posted (Estimate)

April 13, 2010

Last Update Submitted That Met QC Criteria

April 12, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11486

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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