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NCT00500539 · ClinicalTrials.gov registry record · Phase 3

Open Label Study to Assess Safety and Immunogenicity of Omalizumab Liquid Formulation.

A Phase 3 study, sponsored by Novartis.

Completed
Registry status
Phase 3
Development phase
155
Enrollment target

NCT00500539 is a Phase 3 study that has completed, run by Novartis. The registered enrollment target is 155 participants.

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The verdict

NCT00500539, a Phase 3 study, has completed, sponsored by Novartis.

COMPLETED
Registry status
Phase 3
Development phase
155 participants
Enrollment target

Study Summary

The primary objective of this study is to assess the immunogenic potential of the liquid formulation of omalizumab administered over a period of 6 months in moderate to severe persistent allergic asthma patients 12 years of age or older, with no previous exposure to the drug (omalizumab naïve patients). The secondary objective of this study is to assess the safety of the liquid formulation of omalizumab in the same patients.

Interventions

  • DRUG omalizumab

Trial Details

FieldValue
Enrollment Target 155 participants
Start Date 2007-07
Est. Completion 2008-09
Phase Phase 3

Sponsor

Novartis

265 total trials

What the Registry Record Tells You About NCT00500539

The ClinicalTrials.gov registry entry for NCT00500539 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 155 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis, which has 265 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which omalizumab is the first listed.

NCT00500539 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00500539 about?

NCT00500539 is a clinical study titled "Open Label Study to Assess Safety and Immunogenicity of Omalizumab Liquid Formulation.". The primary objective of this study is to assess the immunogenic potential of the liquid formulation of omalizumab administered over a period of 6 months in moderate to severe persistent allergic asthma patients 12 years of age or older, with no previous exposure to the drug (omalizumab naïve patien...

What is the current status of trial NCT00500539?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 155 participants. The study started on 2007-07. Estimated completion is 2008-09.

What interventions are being tested in trial NCT00500539?

The interventions under investigation include: omalizumab (DRUG).

Who is sponsoring clinical trial NCT00500539?

This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.

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.