Study To Evaluate The Safety And Efficacy Of Vfend® IV in Korean patients

Phase 1

• Conditions: Patients diagnosed as ‘invasive aspergillosis’, ‘serious fungal infections caused by Scedosporium apiospermum (asexual form of Pseudallescheria boydii) and Fusarium spp. including Fusarium solani in patients intolerant of, or refractory to, other therapy’ or ‘candidemia in nonneutropenic patients and the following Candida infections: disseminated infections in skin and infections in abdomen, kidney, bladder wall, and wounds’ who have received Vfend IV will be included in the study.; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2017-000197-11-Outside-EU/EEA
• Lead Sponsor: Pfizer Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-15
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Patients diagnosed as ‘invasive aspergillosis’, ‘serious fungal infections caused by Scedosporium apiospermum (asexual form of Pseudallescheria boydii) and Fusarium spp. including Fusarium solani in patients intolerant of, or refractory to, other therapy’ or ‘candidemia in nonneutropenic patients and the following Candida infections: disseminated infections in skin and infections in abdomen, kidney, bladder wall, and wounds’ who have received Vfend IV will be included in the study.
Are the trial subjects under 18? yes
Number of subjects for this age range: 50
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 250
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

Vfend® is contraindicated in the following patients:
-Patients with known hypersensitivity to voriconazole or to any of the excipients.
-Coadministration of the CYP3A4 substrates, terfenadine, astemizole, cisapride, pimozide or quinidine with voriconazole : Increased plasma concentrations of these medicinal products can lead to QTc prolongation and rare occurrences of torsades de pointes.
-Coadministration of voriconazole with rifampicin, carbamazepine and Phenobarbital: These medicinal products are likely to decrease plasma voriconazole concentrations significantly.
-Coadministration of ergot alkaloids (ergotamine, dihydroergotamine), which are CYP3A4 substrates : Increased plasma concentrations of these medicinal products can lead to ergotism.
-Coadministration of voriconazole and sirolimus: Voriconazole is likely to increase plasma concentrations of sirolimus significantly.
-Coadministration of voriconazole with high-dose ritonavir (400 mg and above twice daily) is contraindicated because ritonavir significantly decreased plasma voriconazole concentrations in healthy subjects at this dose.
-Coadministration of voriconazole with efavirenz : Efavirenz significantly decreased voriconazole plasma concentrations while voriconazole also significantly increased efavirenz plasma concentrations.
-Coadministration of voriconazole with St John’s Wort is contraindicated.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified