Vfend Special Investigation For Prophylaxis

NCT02674685

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1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Fungal Infection
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patients undergoing HSCT (Hematopoietic Stem Cell Transplantation).

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.

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Advanced Information
Descriptive Information
Brief Title Vfend Special Investigation For Prophylaxis
Official Title VFEND SPECIAL INVESTIGATION FOR PROPHYLAXIS
Brief Summary Examine the safety and effectiveness of Vfend [voriconazole] for prophylaxix use 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 prophylaxis of invasive fungal infections in patients undergoing HSCT (Hematopoietic Stem Cell Transplantation)
Condition Fungal Infection
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: June 10, 2019)
241
Original Estimated Enrollment
 (submitted: February 3, 2016)
200
Actual Study Completion Date July 3, 2019
Actual Primary Completion Date July 3, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients undergoing HSCT (Hematopoietic Stem Cell Transplantation).

Exclusion Criteria:

  • Patients who have been previously enrolled in this study.
Sex/Gender
Sexes Eligible for Study:All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02674685
Other Study ID Numbers A1501106
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/d….
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2020