Study Evaluating BDDRFVIII and ReFacto AF in 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

2003-02-28

Brief Summary

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The purpose of this study is to determine the relative bioavailability of ReFacto AF as compared to ReFacto, when each is administered as 2-minute bolus infusions.

Detailed Description

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Conditions

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Hemophilia A

Keywords

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Hemophilia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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ReFacto AF

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Severe hemophilia A (FVIII:C \< 1% at local laboratory)
* Previously treated patients (PTP) with at least 250 exposure days to any factor VIII product
* Age greater than or equal to 12 years\\

Exclusion Criteria

* The presence of any bleeding disorder in addition to hemophilia A
* Concomitant therapy with immunosuppressant drugs (e.g., intravenous immunoglobulin (IVIG), routine systemic corticosteroid use)
* History of detectable factor VIII inhibitor

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

References

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Korth-Bradley J, Rupon J, Plotka A, Charnigo R, Rendo P. Assessment of Relative Bioavailability of Moroctocog Alfa and Moroctocog Alfa (AF-CC) in Subjects With Severe Hemophilia A. Clin Transl Sci. 2018 May;11(3):283-288. doi: 10.1111/cts.12544. Epub 2018 Mar 25.

Reference Type DERIVED

PMID: 29575770 (View on PubMed)

Other Identifiers

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3082B1-305

Identifier Type: -

Identifier Source: org_study_id