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NCT04779307 · ClinicalTrials.gov registry record · Phase 3
A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Ulcerative Colitis (UC)
A Phase 3 study, sponsored by Takeda.
- Completed
- Registry status
- Phase 3
- Development phase
- 121
- Enrollment target
NCT04779307 is a Phase 3 study that has completed, run by Takeda. The registered enrollment target is 121 participants.
The verdict
NCT04779307, a Phase 3 study, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 121 participants
- Enrollment target
Study Summary
Vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system. In this study, children and teenagers with moderate to severe ulcerative colitis will be treated with vedolizumab. The main aim of the study is to check if participants achieve remission after treatment with vedolizumab. Remission means symptoms improve or disappear and an endoscopy shows no or limited signs of disease. The study is also evaluating side effects of vedolizumab in the children and teenager with moderately to severely active ulcerative colitis. Participants will receive 3 infusions of vedolizumab over 6 weeks. Then, those who have a clinical response will receive 1 of 3 doses of vedolizumab once every 8 weeks. They will receive the same dose every time.
Interventions
- DRUG Vedolizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 121 participants |
| Start Date | 2021-10-19 |
| Est. Completion | 2025-07-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04779307
The ClinicalTrials.gov registry entry for NCT04779307 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 121 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Vedolizumab is the first listed.
NCT04779307 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04779307 about?
NCT04779307 is a clinical study titled "A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Ulcerative Colitis (UC)". Vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system. In this study, children and teenagers with moderate to severe ulcerative colitis will be treated with vedolizumab. The main aim of the study is to check if participants achieve remission after treatment wi...
What is the current status of trial NCT04779307?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 121 participants. The study started on 2021-10-19. Estimated completion is 2025-07-01.
What interventions are being tested in trial NCT04779307?
The interventions under investigation include: Vedolizumab (DRUG).
Who is sponsoring clinical trial NCT04779307?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
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