CTRI/2015/10/006247
Active, not recruiting
Phase 4
A prospective, Post Marketing Surveillance study to study the safety and effectiveness of omalizumab in Indian patients with Chronic Spontaneous Urticaria refractory to standard of care
ovartis Healthcare Private Limited0 sites0 target enrollmentTBD
ConditionsHealth Condition 1: null- Xolair in CS
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Xolair in CS
- Sponsor
- ovartis Healthcare Private Limited
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. CSU patients prescribed with omalizumab as per approved package insert and who are not treated with omalizumab 6 months prior to entering the study.
- •2\. Patients willing to participate in the study by providing written informed consent.
Exclusion Criteria
- •1\.Contraindication as per PI.
- •2\.Patients simultaneously participating in other studies
- •Pregnant women should not be included except if, in the opinion of the investigator, the expected benefit outweighs the potential risk to the fetus.
Outcomes
Primary Outcomes
Not specified
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