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

NCT00109187 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2013-06-21

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Xolair (omalizumab)

Sponsors & Collaborators

  • Genentech, Inc.

    lead INDUSTRY

Study Design

Purpose
TREATMENT
Masking
NONE

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-06-30
Completion
2003-04-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00109187 on ClinicalTrials.gov