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NCT01033734 · ClinicalTrials.gov registry record · Phase 1

A Study of Intravenous Tamiflu (Oseltamivir) in Children With Influenza

A Phase 1 study of Influenza, sponsored by Hoffmann-La Roche.

Completed
Registry status
Phase 1
Development phase
8
Enrollment target
20
Study locations

NCT01033734 is a Phase 1 study of Influenza that has completed, run by Hoffmann-La Roche. The registered enrollment target is 8 participants, below the 36,804-participant average among 156 other Influenza trials with a reported enrollment target (100% lower). The trial reports 20 study locations across 14 states.

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The verdict

NCT01033734, a Phase 1 study of Influenza, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 1
Development phase
8 participants
Enrollment target
20
Study locations

Study Summary

This open-label study will assess the pharmacokinetics/pharmacodynamics and safety of intravenous (iv) Tamiflu (oseltamivir) in 3 cohorts of children, aged 6-12, 3-5 and 1-2 years, with influenza infection. Patients will receive iv Tamiflu therapy for 5 days (10 doses). For patients whose conditions no longer merit continued iv dosing, therapy may be switched to oral Tamiflu to complete their prescribed course of treatment. If medically necessary, iv or oral therapy with Tamiflu may be continued for up to 5 additional days. Anticipated time on study treatment is 5 to 10 days.

Conditions Studied

Interventions

  • DRUG oseltamivir [Tamiflu]

Study Locations (20)

Massachusetts

  • - Boston
  • - Boston
  • - Boston
  • - Springfield

New York

  • - Brooklyn
  • - New York
  • - Stony Brook

California

  • - Los Angeles
  • - Oakland

Colorado

  • - Aurora

Delaware

  • - Wilmington

Florida

  • - Jacksonville

Illinois

  • - Chicago

Indiana

  • - South Bend

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2010-12
Est. Completion 2012-12
Phase Phase 1

Sponsor

Hoffmann-La Roche

909 total trials

What the Registry Record Tells You About NCT01033734

The ClinicalTrials.gov registry entry for NCT01033734 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 36,804-participant average among 156 other Influenza trials with a reported enrollment target (100% lower). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Influenza appearing as the primary indexed condition, and to 1 intervention - of which oseltamivir [Tamiflu] is the first listed.

NCT01033734 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Massachusetts, New York, California.

Frequently Asked Questions

What is clinical trial NCT01033734 about?

NCT01033734 is a clinical study titled "A Study of Intravenous Tamiflu (Oseltamivir) in Children With Influenza". This open-label study will assess the pharmacokinetics/pharmacodynamics and safety of intravenous (iv) Tamiflu (oseltamivir) in 3 cohorts of children, aged 6-12, 3-5 and 1-2 years, with influenza infection. Patients will receive iv Tamiflu therapy for 5 days (10 doses). For patients whose conditions...

What is the current status of trial NCT01033734?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2010-12. Estimated completion is 2012-12.

What conditions does trial NCT01033734 study?

This clinical trial studies the following conditions: Influenza.

What interventions are being tested in trial NCT01033734?

The interventions under investigation include: oseltamivir [Tamiflu] (DRUG).

Who is sponsoring clinical trial NCT01033734?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01033734 being conducted?

This trial has 20 study locations across California, Colorado, Delaware, Florida, Illinois. 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

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.