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Trial record 1 of 1 for:    NCT01660334
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Voriconazole (Vfend) Special Investigation (Regulatory Post Marketing Commitment Plan)

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ClinicalTrials.gov Identifier: NCT01660334
Recruitment Status : Completed
First Posted : August 8, 2012
Results First Posted : December 17, 2013
Last Update Posted : December 17, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date August 6, 2012
First Posted Date August 8, 2012
Results First Submitted Date May 14, 2013
Results First Posted Date December 17, 2013
Last Update Posted Date December 17, 2013
Study Start Date July 2006
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 30, 2013)
Number of Participants With Serious Treatment Related Adverse Events. [ Time Frame: 16 weeks ]
Adverse events mean all unfavorable events that occur in participants after administration of Voriconazole, irrespective of causal relationship to Voriconazole (including clinically problematic abnormal changes in laboratory test values). Serious adverse events were defined as those including death, fatal risk, hospitalization or prolongation of hospitalization period, continuous dysfunction, those causing malformation, and serious ones like the above-cited events. Treatment related Adverse Events were evaluated in company with the causal relationship to Voriconazole.
Original Primary Outcome Measures
 (submitted: August 6, 2012)
Number of Participants With Adverse Events (AEs) by Seriousness and Relationship to Treatment [ Time Frame: 16 weeks ]
Change History Complete list of historical versions of study NCT01660334 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 30, 2013)
Number of Participants With Clinical Response of Cure at the Test-of-Cure(TOC) Visit. [ Time Frame: 16 weeks ]
The primary endpoint was the efficacy ratio (number of effective cases/number of evaluable cases for efficacy assessment) among the cohort comprising the participants for efficacy analysis. Clinical response of cure was assessed comprehensively by physicians in the three categories, which were "effective", "ineffective", and "not evaluable", based on the clinical symptoms, imaging diagnosis and endoscopy, fungal tests, and serological tests.
Original Secondary Outcome Measures
 (submitted: August 6, 2012)
Number of Participants with Clinical Response of Cure at the Test-of-Cure (TOC) Visit [ Time Frame: 16 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Voriconazole (Vfend) Special Investigation (Regulatory Post Marketing Commitment Plan)
Official Title Special Investigation of Vfend on Scedosporisis
Brief Summary To collect the efficacy and safety information of voriconazole related to their appropriate use in daily practice.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population The patients whom an investigator involving A1501077 prescribes the voriconazole (VFEND).
Condition Scedosporium Infection
Intervention Drug: Voriconazole

Voriconazole Intravenous Solution 200 mg:

Voriconazole is administered by intravenous drip infusion at the dose of 6 mg/kg twice daily on day 1 and 3 mg/kg or 4 mg/kg twice daily from day 2 onward in adults.

Voriconazole Tablet 50 mg/ Voriconazole Tablet 200 mg:

administration for an adult (weighing 40 kg or more) is voriconazole 300mg orally twice daily between meals for day 1 and then 150 mg or 200 mg twice daily between meals from day 2 onward.

Depending on the symptoms or in cases where the effect is insufficient, the dosage may be increased.

However, the maximum dose on day 1 must be 400 mg twice daily, and the maximum dose from day 2 onward must be 300 mg twice daily.

In patients weighing less than 40 kg, voriconazole 150 mg shall be administered twice daily on day 1, and voriconazole 100 mg shall be administered twice daily from day 2 onward.

Depending on the symptoms, the maintenance dose from day 2 onward may be increased to 150 mg twice daily.

Other Name: VFEND for Intravenous Use, Voriconazole for Intravenous Use, VFEND Tablets, Voriconazole Tablet
Study Groups/Cohorts Voriconazole
Subjects who are treated with voriconazole
Intervention: Drug: Voriconazole
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: August 6, 2012)
13
Original Actual Enrollment Same as current
Actual Study Completion Date May 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

Male or Female patients who are prescribed voriconazole (VFEND) for deep mycosis on Scedosporisis.

Exclusion Criteria:

Subject who have been prescribed voriconazole (VFEND) for deep mycosis on Aspergillus, Candidasis,Cryptococcal infections not involving Scedosporisis.

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 NCT01660334
Other Study ID Numbers A1501077
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date October 2013