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| Tracking Information | |
|---|---|
| First Received Date ICMJE | April 26, 2005 |
| Last Updated Date | June 23, 2005 |
| Start Date ICMJE | |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00109200 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | A Continued Access Protocol to Provide Xolair to Patients With Severe Allergic Asthma |
| Official Title ICMJE | A Continued Access Protocol to Provide Xolair® (Omalizumab) to Subjects With Severe Allergic Asthma Who Have Received Xolair Treatment in a Previous Investigational Study |
| Brief Summary | 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. |
| Detailed Description | |
| Study Phase | Phase III |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment |
| Condition ICMJE | Asthma |
| Intervention ICMJE | Drug: Xolair (omalizumab) |
| Study Arms / Comparison Groups | |
| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | |
| Completion Date | |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both |
| Ages | |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | |
| Administrative Information | |
| NCT ID ICMJE | NCT00109200 |
| Responsible Party | |
| Study ID Numbers ICMJE | Q2736g |
| Study Sponsor ICMJE | Genentech |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | Genentech |
| Verification Date | April 2005 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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