Non-Interventional Post Marketing Surveillance Study To Observe The Safety And Efficacy Of Vfend® IV

NCT ID: NCT01073618

Last Updated: 2012-06-07

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

Total Enrollment

692 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-03-31

Study Completion Date

2009-10-31

Brief Summary

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This is non-interventional study of voriconazole IV formulation in clinical use, which was mandated by the Korean government agency following the approval of Vfend in the Republic of Korea.

Detailed Description

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Conditions

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Serious Fungal Infections

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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A.

Patients who are indicated for VFEND according to drug package insert.

voriconazole IV

Intervention Type DRUG

6 mg/kg iv q 12 hours (loading) then maintenance

Interventions

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voriconazole IV

6 mg/kg iv q 12 hours (loading) then maintenance

Intervention Type DRUG

Other Intervention Names

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Vfend

Eligibility Criteria

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Inclusion Criteria

* Invasive aspergillosis and other serious fungal infections.

Exclusion Criteria

* N/A
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Related Links

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Other Identifiers

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A1501067

Identifier Type: -

Identifier Source: org_study_id

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