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

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.
ClinicalTrials.gov Identifier: NCT00109187
Recruitment Status : Completed
First Posted : April 26, 2005
Last Update Posted : June 21, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Xolair (omalizumab) Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 0 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label Extension Study II of Xolair (Omalizumab) in Moderate to Severe, Persistent Asthma Subjects Who Completed Study Q2143g (ALTO)
Study Start Date : June 2002
Study Completion Date : April 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Omalizumab
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

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:

  • Successful completion of the 24-week study period in Study Q2143g
  • Signed informed consent (in the case of a minor, consent must be given by the child's parent or legally authorized representative)
  • For subjects who have never received Xolair, a serum IgE level >=30 IU/mL and <=1300 IU/mL and have a body weight >=20 kg and <=150 kg
  • 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.

Exclusion Criteria:

  • Thrombocytopenia as evidenced by a platelet count of <100,000/uL
  • Pregnant or breastfeeding
  • Significant systemic disease (e.g., infection, hematologic, renal, hepatic, coronary heart disease or other cardiovascular diseases, endocrine or gastrointestinal disease) within the previous 3 months
  • History of neoplasia
  • Any systemic condition requiring regular administration of an immunoglobulin
  • Known hypersensitivity to any ingredients of Xolair, including excipients (sucrose, histidine, polysorbate 20)
  • History of noncompliance with medical regimens
  • Current participation in a study using an investigational new drug other than Xolair
  • Participation in Study Q2195g
More Information

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00109187     History of Changes
Other Study ID Numbers: Q2461g
First Posted: April 26, 2005    Key Record Dates
Last Update Posted: June 21, 2013
Last Verified: June 2013

Keywords provided by Genentech, Inc.:
Moderate Persistent Asthma
Severe Persistent 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