Study Evaluating ReFacto AF in Severe Hemophilia A

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Completion Date

2004-08-31

Brief Summary

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To characterize the safety and efficacy of ReFacto AF in treating acute bleeding episodes during prophylaxis treatment, including neoantigenicity.

Detailed Description

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Conditions

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Hemophilia A

Keywords

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Severe Hemophilia A

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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ReFacto AF

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Severe hemophilia A (FVIII:C less than or equal to 2% at local laboratory)
* Previously treated patients with greater than or equal to 250 exposure days to any Factor VIII product
* Age greater than or equal to 12 years
* History of prophylaxis dosing at least twice per week on any Factor VIII product for at least 3 consecutive months within the 2 years prior to study enrollment unless the patient completed the previous pharmacokinetic study
* Adequate laboratory results

Exclusion Criteria

* Presence of any bleeding disorder in addition to hemophilia A
* Concomitant therapy with immunosuppressive drugs
* Current or historical Factor VIII inhibitor
* Treatment with any investigational drug or device within the past 30 days

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Medical Monitor, MD

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Countries

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United States

Other Identifiers

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3082B1-306

Identifier Type: -

Identifier Source: org_study_id