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| Sponsor: | Genentech |
|---|---|
| Information provided by: | Genentech |
| ClinicalTrials.gov Identifier: | NCT00109200 |
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 III |
| Study Type: | Interventional |
| Study Design: | 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 |
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Study ID Numbers: | Q2736g |
| Study First Received: | April 26, 2005 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00109200 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Allergic Asthma Severe Allergic Asthma |
|
Respiratory System Agents Bronchial Diseases Immune System Diseases Anti-Asthmatic Agents Asthma Anti-Allergic Agents Pharmacologic Actions Lung Diseases, Obstructive |
Hypersensitivity Respiratory Tract Diseases Lung Diseases Therapeutic Uses Hypersensitivity, Immediate Respiratory Hypersensitivity Omalizumab |