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NCT00001810 · ClinicalTrials.gov registry record · Phase 3

An Open Label, Non-Comparative, Multicenter, Phase III Trial of the Efficacy, Safety and Toleration of Voriconazole in the Primary or Secondary Treatment of Invasive Fungal Infections

A Phase 3 study of Mycoses and Candidiasis, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 3
Development phase
300
Enrollment target
1
Study location

NCT00001810 is a Phase 3 study of Mycoses and Candidiasis that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 300 participants, roughly in line with the 304-participant average among 7 other Mycoses trials with a reported enrollment target. The trial reports 1 study location across 1 state.

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The verdict

NCT00001810, a Phase 3 study of Mycoses and Candidiasis, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 3
Development phase
300 participants
Enrollment target
1
Study location

Study Summary

The objective of this study is to evaluate the efficacy, safety and toleration of voriconazole in the primary treatment of systemic or invasive fungal infections due to fungal pathogens for which there is no licensed therapy; and in the secondary treatment of systemic or invasive fungal infections in patients failing or intolerant to treatment with approved systemic antifungal agents. This trial is a Phase II multicenter, open label study investigating the utilization of voriconazole for the treatment of systemic or invasive fungal infections. Enrollment is targeted for 150 patients to be recruited from multiple centers. The patient population will consist of patients with proven, deeply invasive fungal infection for which there is no licensed therapy or if the patient is failing or intolerant to treatment with approved systemic antifungal agents. Voriconazole will be administered initially by a loading dose of 6 mg/kg q12 hours for the first two doses followed by 4 mg/kg q12 hours. Efficacy will be evaluated by clinical, radiological and microbiological response.

Conditions Studied

Mycoses Candidiasis Fungemia Aspergillosis

Interventions

  • DRUG Voriconazole

Study Locations (1)

Maryland

  • National Cancer Institute (NCI) - Bethesda

Trial Details

FieldValue
Enrollment Target 300 participants
Start Date 1999-04
Est. Completion 2000-10
Phase Phase 3

Sponsor

National Cancer Institute (NCI)

3,257 total trials

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What the Registry Record Tells You About NCT00001810

The ClinicalTrials.gov registry entry for NCT00001810 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 304-participant average among 7 other Mycoses trials with a reported enrollment target. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Mycoses appearing as the primary indexed condition, and to 1 intervention - of which Voriconazole is the first listed.

NCT00001810 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT00001810 about?

NCT00001810 is a clinical study titled "An Open Label, Non-Comparative, Multicenter, Phase III Trial of the Efficacy, Safety and Toleration of Voriconazole in the Primary or Secondary Treatment of Invasive Fungal Infections". The objective of this study is to evaluate the efficacy, safety and toleration of voriconazole in the primary treatment of systemic or invasive fungal infections due to fungal pathogens for which there is no licensed therapy; and in the secondary treatment of systemic or invasive fungal infections i...

What is the current status of trial NCT00001810?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 300 participants. The study started on 1999-04. Estimated completion is 2000-10.

What conditions does trial NCT00001810 study?

This clinical trial studies the following conditions: Mycoses, Candidiasis, Fungemia, Aspergillosis.

What interventions are being tested in trial NCT00001810?

The interventions under investigation include: Voriconazole (DRUG).

Who is sponsoring clinical trial NCT00001810?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00001810 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.