drugset / Trial / NCT00109187

An Extension Study of Xolair in Moderate to Severe, Persistent Asthma Patients Who Completed Study Q2143g

NCT00109187

Phase 3 Completed Genentech, Inc.
Open-labelTreatment

Summary

This is a Phase IIIb, multicenter, open-label, extension study available to subjects who successfully complete Study Q2143g and have not participated in Study Q2195g. Subjects should be registered via the IVRS (Interactive Voice Response System) within 48 hours prior to their baseline visit. All subjects in this study will be treated with Xolair for 24 weeks. Subjects in the New Treatment Group may require additional visits for study drug injections (as frequently as every 2 weeks). Data collection during these additional visits will be limited to the assessment of adverse events. The study will evaluate all serious and nonserious adverse events, laboratory assessments, data on asthma exacerbations, and concomitant medication usage.

Timeline

Start
2002-06
Primary completion
Completion
2003-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Omalizumab Monoclonal antibody

Indications