A Continued Access Protocol to Provide Xolair to Patients With Severe Allergic Asthma

June 19, 2013 updated by: Genentech, Inc.

A Continued Access Protocol to Provide Xolair® (Omalizumab) to Subjects With Severe Allergic Asthma Who Have Received Xolair Treatment in a Previous Investigational Study

This is a continued access protocol to provide subjects who have completed Genentech, Inc. Study Q2143g, Q2195g, or Q2461g or Novartis Pharmaceuticals Corporation Study CIGE025 0010E1 with continued Xolair treatment. Subject eligibility will be based on disease severity and asthma deterioration upon withdrawal of Xolair treatment. Subjects whose last Xolair dose was <9 months prior to screening visit will continue with the same Xolair dosing regimen that they received in the previous Genentech or Novartis clinical study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Completion of Genentech Study Q2143g, Q2195g, or Q2461g or Novartis Study CIGE025 0010E1
  • Signed informed consent document (in the case of a minor, consent must be given by the child's parent or legally authorized representative)
  • Females of childbearing potential must, in the opinion of the investigator, be using an effective method of contraception to prevent pregnancy and agree to continue to practice an acceptable method of contraception for the duration of their participation in the study.
  • Severe asthma as demonstrated by at least one of the following: *History of prior intubation for allergic asthma; *History of prior admission to an intensive care unit/pediatric ICU for asthma; *History of one or more hospitalizations, emergency room (ER) visits, or unscheduled office visits for asthma in the 12 months prior to first Xolair treatment; *More than 20 days missed from school/work because of allergic asthma in the 12 months prior to initiation of Xolair treatment
  • Deterioration of asthma upon withdrawal of Xolair as demonstrated by meeting at least one of the following: *Worsening of pulmonary function tests (FEV1 <80% predicted for height, age, and sex) and activity levels while off Xolair treatment; *Worsening of asthma exacerbations defined as doubling of inhaled steroid dose, increase in dose of oral steroids, or initiation of oral, intravenous, intramuscular, or subcutaneous (SC) steroids while off Xolair treatment; *Increased use of rescue medications while off Xolair treatment; *ER visits or unscheduled office visits for asthma that may or may not result in hospitalization while off Xolair treatment

Exclusion Criteria:

  • Pregnancy or lactation
  • Significant systemic disease (e.g., hematologic, renal, hepatic, coronary heart, endocrine, gastrointestinal disease, other cardiovascular diseases, or infection) within the previous 3 months
  • History of neoplasia (including basal cell carcinoma)
  • Any systemic condition requiring regular administration of an immunoglobulin
  • Known hypersensitivity to any ingredients of Xolair, including excipients (sucrose, histidine, polysorbate 20)
  • Current treatment with warfarin (Coumadin(R)), immunomodulatory therapy (e.g., methotrexate, gold, cyclosporine), or antiplatelet therapy
  • Current participation in a study using an investigational new drug other than Xolair

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2003

Study Completion (Actual)

September 1, 2003

Study Registration Dates

First Submitted

April 26, 2005

First Submitted That Met QC Criteria

April 25, 2005

First Posted (Estimate)

April 26, 2005

Study Record Updates

Last Update Posted (Estimate)

June 21, 2013

Last Update Submitted That Met QC Criteria

June 19, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Q2736g

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Asthma

Clinical Trials on Xolair (omalizumab)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Estonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe