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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01151085
First received: June 24, 2010
Last updated: May 14, 2013
Last verified: May 2013
  Purpose

To collect the efficacy and safety informations of voriconazole related to their appropriate use in daily practice.


Condition Intervention
Systemic Mycosis
Drug: Voriconazole

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Vfend Drug Use Investigation (Regulatory Post Marketing Commitment Plan)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants With the Frequency of Treatment Related Adverse Events. [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Number of Unlisted Treatment Related Adverse Events in Japanese Package Insert. [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Number of participants that responded to voriconazole to determine whether severity of infections(mild, moderate or severe) is significant risk factor.


Enrollment: 1002
Study Start Date: April 2006
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Voriconazole
Subjects who are treated with voriconazole
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The patients whom an investigator involving A1501076 prescribes the voriconazole (VFEND).

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01151085

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01151085     History of Changes
Other Study ID Numbers: A1501076
Study First Received: June 24, 2010
Results First Received: May 14, 2013
Last Updated: May 14, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Pfizer:
Systemic Mycosis
Aspergillus infection
Candidiasis
Cryptococcal infections
Japanese
voriconazole
VFEND
Regulatory Post Marketing Commitment Plan.

Additional relevant MeSH terms:
Mycoses
Voriconazole
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 01, 2014