Status:
TERMINATED
An Exploratory Study to Assess Multiple Doses of Omalizumab in Patients With Cystic Fibrosis Complicated by Acute Bronchopulmonary Aspergillosis (ABPA)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Cystic Fibrosis
Allergic Bronchopulmonary Aspergillosis
Eligibility:
All Genders
12+ years
Phase:
PHASE4
Brief Summary
This study will evaluate the safety and efficacy of omalizumab for the treatment of Allergic Bronchopulmonary Aspergillosis (ABPA) in patients with Cystic Fibrosis aged 12 years and older.
Eligibility Criteria
Inclusion
- Diagnosis of Cystic Fibrosis complicated by Allergic Bronchopulmonary Aspergillosis (ABPA)
- Oral corticosteroid use for ABPA flare
- Age 12 years and older (except for Italy; ≥ 18 years)
- Total serum IgE levels ≥ 500 IU/mL
Exclusion
- History of cancer in the last 10 years.
- History of severe allergic reactions
- Pregnant and lactating women
- Prior use of Xolair
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00787917
Start Date
November 1 2008
End Date
July 1 2010
Last Update
September 26 2011
Active Locations (10)
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1
Novartis Investigator Site
Leuven, Belgium
2
Novartis Investigator Site
Berlin, Germany
3
Novartis Investigator Site
Bonn, Germany
4
Novartis Investigator Site
Munich, Germany