Long-term Safety Study of QGE031 in Patients With Allergic Asthma Who Completed Study CQGE031B2201
| Status: | Completed |
|---|---|
| Conditions: | Asthma |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 76 |
| Updated: | 8/4/2016 |
| Start Date: | March 2014 |
| End Date: | March 2016 |
An Open-label, Multi-center, Extension Study to Evaluate the Long-term Safety of Subcutaneous 240mg QGE031 Given Every 4 Weeks for 52 Weeks in Allergic Asthma Patients Who Completed Study CQGE031B2201
This study will assess long-term safety of QGE031 during 12 months treatment in asthma
patients who completed study CQGE031B2201.
patients who completed study CQGE031B2201.
This study will assess long-term safety and tolerability of QGE031 administered every 4
weeks for an additional 12 months in patients with allergic asthma who previously completed
study CQGE031B2201.
weeks for an additional 12 months in patients with allergic asthma who previously completed
study CQGE031B2201.
Key Inclusion Criteria:
- forced Expiratory Volume in one second ( FEV1) > 40% predicted
- patients who completed CQGE031B2201 study
Key Exclusion Criteria:
- life-threatening asthma attack, intubation, respiratory arrest during or after
completion of CQGE031B2201 study
- new malignancy
- ongoing SAE from CQGE031B2201 that was assessed as related to study drug
- patient experienced platelets drop to < 75,000/uL
- patient experienced one unexpected grade 4 or two unexpected grade 3 hypersensitivity
reactions
- patient is pregnant
We found this trial at
6
sites
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