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

Systemic Mycosis Clinical Trial

Official title:

Vfend Drug Use Investigation (Regulatory Post Marketing Commitment Plan)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01151085
• Other study ID #: A1501076
• Status: Completed
• Phase: N/A
• First received: June 24, 2010
• Last updated: May 14, 2013
• Start date: April 2006
• Est. completion date: May 2012

Study information

• Verified date: May 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1002
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With the Frequency of Treatment Related Adverse Events.	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.	16 weeks	Yes
Primary	Number of Participants That Responded to Voriconazole Treatment.	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.	16 weeks	No
Secondary	Number of Unlisted Treatment Related Adverse Events in Japanese Package Insert.	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.	16 weeks	Yes
Secondary	Risk Factors for the Frequency of Treatment Related Adverse Events -Gender.	Number of participants with Treatment Related Adverse Events of Voriconazole to determine whether male or female is significant risk factor.	16 weeks	Yes
Secondary	Risk Factors for the Frequency of Treatment Related Adverse Events -Severity of Infections.	Number of participants with Treatment Related Adverse Events of Voriconazole to determine whether severity of infections(mild, moderate or severe) is significant risk factor.	16 weeks	Yes
Secondary	Risk Factors for the Frequency of Treatment Related Adverse Events -Past History.	Number of participants with Treatment Related Adverse Events of Voriconazole to determine whether with or without Past History is significant risk factor.	16 weeks	Yes
Secondary	Number of Participants That Responded to Voriconazole Treatment -Severity of Infections.	Number of participants that responded to voriconazole to determine whether severity of infections(mild, moderate or severe) is significant risk factor.	16 weeks	No

External Links

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