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Vfend Special Investigation For Pediatric - Observational

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02554656
Recruitment Status : Completed
First Posted : September 18, 2015
Last Update Posted : March 29, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
Examine the safety and effectiveness of Vfend [voriconazole] for pediatric under general clinical practices.

Condition or disease
Pediatric Safety and Effectiveness

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Study Type : Observational
Actual Enrollment : 89 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: VFEND SPECIAL INVESTIGATION- INVESTIGATION FOR TREATMENT OF INVASIVE FUNGAL INFECTIONS IN PEDIATRIC PATIENTS -
Actual Study Start Date : October 2015
Actual Primary Completion Date : September 2018
Actual Study Completion Date : September 2018



Primary Outcome Measures :
  1. Number of Participants With Adverse Events (AEs) by Seriousness and Relationship to Treatment [ Time Frame: Maximum 16 weeks ]

Secondary Outcome Measures :
  1. Number of Participants with Clinical Response of Cure at the Test-of-Cure (TOC) Visit [ Time Frame: Maximum 16 weeks ]


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Ages Eligible for Study:   up to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The subjects who have been treated with voriconazole for severe mycosis
Criteria

Inclusion Criteria:

  • Patients who is under 15 years old and deep mycosis infection.

Exclusion Criteria:

  • Patients who have been previously enrolled in this study. -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02554656


Locations
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Japan
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Osaka, Japan
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02554656     History of Changes
Other Study ID Numbers: A1501100
First Posted: September 18, 2015    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.