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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00109200
First Posted: April 26, 2005
Last Update Posted: June 21, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Genentech, Inc.
  Purpose
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.

Condition Intervention Phase
Asthma Drug: Xolair (omalizumab) Phase 3

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Continued Access Protocol to Provide Xolair® (Omalizumab) to Subjects With Severe Allergic Asthma Who Have Received Xolair Treatment in a Previous Investigational Study

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Study Start Date: May 2003
Study Completion Date: September 2003
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00109200     History of Changes
Other Study ID Numbers: Q2736g
First Submitted: April 26, 2005
First Posted: April 26, 2005
Last Update Posted: June 21, 2013
Last Verified: June 2013

Keywords provided by Genentech, Inc.:
Allergic Asthma
Severe Allergic Asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Omalizumab
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents