You are here

Vfend Special Investigation For Pediatric - Observational

Last updated on November 18, 2019

FOR MORE INFORMATION
Study Location
XXXXXXX
Osaka, , Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pediatric Safety and Effectiveness
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0-15
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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

NCT02554656
Pfizer
Completed
Vfend Special Investigation For Pediatric - Observational

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Descriptive Information
Brief TitleVfend Special Investigation For Pediatric - Observational
Official TitleVFEND SPECIAL INVESTIGATION- INVESTIGATION FOR TREATMENT OF INVASIVE FUNGAL INFECTIONS IN PEDIATRIC PATIENTS -
Brief SummaryExamine the safety and effectiveness of Vfend [voriconazole] for pediatric under general clinical practices.
Detailed DescriptionNot Provided
Study TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodProbability Sample
Study PopulationThe subjects who have been treated with voriconazole for severe mycosis
ConditionPediatric Safety and Effectiveness
InterventionNot Provided
Study Groups/CohortsNot 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 StatusCompleted
Actual Enrollment
 (submitted: October 3, 2018)
89
Original Estimated Enrollment
 (submitted: September 17, 2015)
100
Actual Study Completion DateSeptember 2018
Actual Primary Completion DateSeptember 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
Agesup to 15 Years   (Child)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesJapan
Removed Location Countries  
 
Administrative Information
NCT NumberNCT02554656
Other Study ID NumbersA1501100
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot 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/da....
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMarch 2019

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now