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

Vfend Drug Use Investigation (Regulatory Post Marketing Commitment Plan)

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

Study Overview

• Status: Completed
• Conditions: Systemic Mycosis
• Intervention / Treatment: Drug: Voriconazole

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
• Enrollment (Actual): 1002

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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 Names: VFEND for Intravenous Use, Voriconazole for Intravenous Use, VFEND Tablets, Voriconazole Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: April 1, 2006
• Primary Completion (ACTUAL): May 1, 2012
• Study Completion (ACTUAL): May 1, 2012

Study Registration Dates

• First Submitted: June 24, 2010
• First Submitted That Met QC Criteria: June 24, 2010
• First Posted (ESTIMATE): June 25, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): August 8, 2013
• Last Update Submitted That Met QC Criteria: May 14, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: Japanese; Candidiasis; voriconazole; VFEND; Systemic Mycosis; Regulatory Post Marketing Commitment Plan.; Aspergillus infection; Cryptococcal infections
• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Mycoses; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Voriconazole
• Other Study ID Numbers: A1501076