Study Evaluating B-Domain Deleted Recombinant Factor VIII (BDDrFVIII, ReFacto AF) in Patients With Hemophilia A Undergoing Elective Major Surgery

NCT ID: NCT00243659

Last Updated: 2011-06-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2008-06-30

Brief Summary

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This study will examine the efficacy and safety of ReFacto AF in patients with severe and moderately severe hemophilia A undergoing elective major surgery when administered by either bolus injections (BI) or continuous infusion (CI).

Detailed Description

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Conditions

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Hemophilia A

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

ReFacto AF

Intervention Type BIOLOGICAL

B

Group Type EXPERIMENTAL

ReFacto AF

Intervention Type BIOLOGICAL

Interventions

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ReFacto AF

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Male, at least 12 years old, with severe hemophilia A undergoing major elective major surgery requiring FVIII replacement for at least 6 days. Negative FVIII inhibitor test at screening and no past history of inhibitor.
* Previously treated with at least 150 exposure days to any Factor VIII product
* Normal hepatic and renal function tests and no other bleeding disorder
Minimum Eligible Age

12 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Wyeth

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Locations

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La Jolla, California, United States

Site Status

Detroit, Michigan, United States

Site Status

Detroit, Michigan, United States

Site Status

Chapel Hill, North Carolina, United States

Site Status

Hershey, Pennsylvania, United States

Site Status

Pittsburgh, Pennsylvania, United States

Site Status

Houston, Texas, United States

Site Status

Charlottesville, Virginia, United States

Site Status

Perth, , Australia

Site Status

Vienna, , Austria

Site Status

Budapest, , Hungary

Site Status

Auckland, , New Zealand

Site Status

Chirstchurch, , New Zealand

Site Status

Warsaw, , Poland

Site Status

Bucurest, , Romania

Site Status

Malmo, , Sweden

Site Status

Stockholm, , Sweden

Site Status

Countries

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United States Australia Austria Hungary New Zealand Poland Romania Sweden

Other Identifiers

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3082B2-311

Identifier Type: -

Identifier Source: org_study_id

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