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

NCT01151085 | Completed Results

• 1 other identifier: A1501076
• Study Type: observational
• Target: 1,002
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Systemic Mycosis

Keywords

Systemic Mycosis; Aspergillus infection; Candidiasis; Cryptococcal infections; Japanese; voriconazole; VFEND; Regulatory Post Marketing Commitment Plan.

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Number of Unlisted Treatment Related Adverse Events in Japanese Package Insert.

  16 weeks

• Risk Factors for the Frequency of Treatment Related Adverse Events -Gender.

  16 weeks

• Risk Factors for the Frequency of Treatment Related Adverse Events -Severity of Infections.

  16 weeks

• Risk Factors for the Frequency of Treatment Related Adverse Events -Past History.

  16 weeks

• Number of Participants That Responded to Voriconazole Treatment -Severity of Infections.

  16 weeks

Study Arms (1)

Voriconazole

Subjects who are treated with voriconazole

Drug: Voriconazole

Interventions

Voriconazole DRUG

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.

Also known as: VFEND for Intravenous Use, Voriconazole for Intravenous Use, VFEND Tablets, Voriconazole Tablet

Voriconazole

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Male or Female subjects intend to treat their deep mycosis who are prescribed voriconazole (VFEND) by their Physicians.

You may not qualify if:

• Subject who heve been prescribed voriconazole (VFEND) before.

Sponsors & Collaborators

• Pfizer: lead

Related Links

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

MeSH Terms

Conditions

Aspergillosis; Candidiasis

Interventions

Voriconazole

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2010
• First Posted: June 25, 2010
• Study Start: April 1, 2006
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: August 8, 2013
• Results First Posted: August 8, 2013

Record last verified: 2013-05