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Trial record 1 of 1 for:    NCT02554656
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Vfend Special Investigation For Pediatric - Observational

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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

Tracking Information
First Submitted Date July 15, 2015
First Posted Date September 18, 2015
Last Update Posted Date March 29, 2019
Actual Study Start Date October 2015
Actual Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 17, 2015)
Number of Participants With Adverse Events (AEs) by Seriousness and Relationship to Treatment [ Time Frame: Maximum 16 weeks ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02554656 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 17, 2015)
Number of Participants with Clinical Response of Cure at the Test-of-Cure (TOC) Visit [ Time Frame: Maximum 16 weeks ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Vfend Special Investigation For Pediatric - Observational
Official Title VFEND SPECIAL INVESTIGATION- INVESTIGATION FOR TREATMENT OF INVASIVE FUNGAL INFECTIONS IN PEDIATRIC PATIENTS -
Brief Summary Examine the safety and effectiveness of Vfend [voriconazole] for pediatric under general clinical practices.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population The subjects who have been treated with voriconazole for severe mycosis
Condition Pediatric Safety and Effectiveness
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 3, 2018)
89
Original Estimated Enrollment
 (submitted: September 17, 2015)
100
Actual Study Completion Date September 2018
Actual Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Eligibility 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. -
Sex/Gender
Sexes Eligible for Study: All
Ages up to 15 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT02554656
Other Study ID Numbers A1501100
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
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.
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2019