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Long-term Safety of Intravenous Vedolizumab in Pediatric Ulcerative Colitis and Crohn's Disease (Extension Study)
jRCT2071230036Phase 3Recruiting
- Sponsor
- Takeda
- Start
- May 2023
- Modality
- Monoclonal Antibodies → Antibody-Based Therapeutics
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Overview
Phase 3, open-label trial of vedolizumab in autoimmune colitis and Crohn's disease (7 arms), sponsored by Takeda. Primary endpoints: Number of Participants With at Least One Adverse Event (AE) in Treatment Cohort and Number of Participants With Prespecified Safety Events in Observational Cohort. Started May 2023; status: recruiting.
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Drugs
vedolizumab
03
Conditions
autoimmune colitisCrohn's disease
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