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Voriconazole (Vfend) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)

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ClinicalTrials.gov Identifier: NCT01151085
Recruitment Status : Completed
First Posted : June 25, 2010
Results First Posted : August 8, 2013
Last Update Posted : August 8, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date June 24, 2010
First Posted Date June 25, 2010
Results First Submitted Date May 14, 2013
Results First Posted Date August 8, 2013
Last Update Posted Date August 8, 2013
Study Start Date April 2006
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 14, 2013)
  • Number of Participants With the Frequency of 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). Treatment related Adverse Events were evaluated in company with the causal relationship to Voriconazole.
  • Number of Participants That Responded to Voriconazole Treatment. [ 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 subjects for efficacy analysis.
Original Primary Outcome Measures
 (submitted: June 24, 2010)
  • The frequency of voriconazole treatment related adverse events. [ Time Frame: 16 weeks ]
  • The proportion of responders to voriconazole treatment. [ Time Frame: 16 weeks ]
Change History Complete list of historical versions of study NCT01151085 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 14, 2013)
  • Number of Unlisted Treatment Related Adverse Events in Japanese Package Insert. [ 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). Number of Treatment Related Adverse Events were evaluated in company with the causal relationship to Voriconazole. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert.
  • Risk Factors for the Frequency of Treatment Related Adverse Events -Gender. [ Time Frame: 16 weeks ]
    Number of participants with Treatment Related Adverse Events of Voriconazole to determine whether male or female is significant risk factor.
  • Risk Factors for the Frequency of Treatment Related Adverse Events -Severity of Infections. [ Time Frame: 16 weeks ]
    Number of participants with Treatment Related Adverse Events of Voriconazole to determine whether severity of infections(mild, moderate or severe) is significant risk factor.
  • Risk Factors for the Frequency of Treatment Related Adverse Events -Past History. [ Time Frame: 16 weeks ]
    Number of participants with Treatment Related Adverse Events of Voriconazole to determine whether with or without Past History is significant risk factor.
  • Number of Participants That Responded to Voriconazole Treatment -Severity of Infections. [ Time Frame: 16 weeks ]
    Number of participants that responded to voriconazole to determine whether severity of infections(mild, moderate or severe) is significant risk factor.
Original Secondary Outcome Measures
 (submitted: June 24, 2010)
  • Treatment related unlisted adverse events in Japanese Package insert. [ Time Frame: 16 weeks ]
  • Risk factors likely to affect the frequency of treatment related adverse events. [ Time Frame: 16 weeks ]
  • Risk factors likely to affect the proportion of responders. [ 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) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
Official Title Vfend Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
Brief Summary To collect the efficacy and safety informations of voriconazole related to their appropriate use in daily practice.
Detailed Description All the subjects whom an investigator prescribes the first voriconazole (VFEND) should be registered consecutively until the number of subjects reaches target number in order to extract subjects enrolled into the investigation at random.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population The patients whom an investigator involving A1501076 prescribes the voriconazole (VFEND).
Condition Systemic Mycosis
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: April 8, 2013)
1002
Original Estimated Enrollment
 (submitted: June 24, 2010)
1100
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 subjects intend to treat their deep mycosis who are prescribed voriconazole (VFEND) by their Physicians.

Exclusion Criteria:

  • Subject who heve been prescribed voriconazole (VFEND) before.
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 NCT01151085
Other Study ID Numbers A1501076
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 May 2013