An Open-Label Study To Assess The Pharmacokinetics, Safety And Toleration Of Vfend®; Following Multiple Dosing With Vfend

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Pfizer

Status and phase

Terminated
Phase 2
Phase 1

Conditions

Kidney Failure

Treatments

Drug: Vfend®; I.V.

Study type

Interventional

Funder types

Industry

Identifiers

NCT00150319
A1501070

Details and patient eligibility

About

This is a study to investigate the pharmacokinetics, safety and tolerability of intravenous voriconazole and SBECD in patients with moderate renal insufficiency

Full description

The study was put on hold after the first subject was enrolled and experienced a serious adverse event (SAE) of renal failure chronic after receiving his I.V. dose on Day 1. The study was taken off hold after the subject recovered and an independent consultant had deemed the SAE as not treatment related; however, the site was unwilling to enroll additional subjects. Another site, based in New Orleans, was damaged by hurricane Katrina and was unable to enroll any subjects. A decision was made by the sponsor to terminate the study on 11 Apr 2006 due to poor study enrollment. There were no safety or efficacy concerns regarding the study in the decision to terminate the trial.

Enrollment

1 patient

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with moderate renal insufficiency

Exclusion criteria

Active infection

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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