NCT05113095 A Survey of Darvadstrocel in People With Crohn's Disease
| NCT ID | NCT05113095 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Takeda |
| Condition | Crohn's Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 275 participants |
| Start Date | 2021-11-30 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 275 participants in total. It began in 2021-11-30 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is a survey in Japan of Darvadstrocel injection used to treat Crohn's disease people with complicated anal fistula. The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study. The main aim of the study is to check for side effects related from Darvadstrocel injection and to check if Darvadstrocel injection improves symptoms of Crohn's disease. During the study, participants with Crohn's disease will take Darvadstrocel injection according to their clinic's standard practice. The study doctors will check for side effects from Darvadstrocel for 36 months.
Eligibility Criteria
Inclusion Criteria All patients with complex perianal fistulas in Crohn's Disease who received Darvadstrocel will be included. Exclusion Criteria None
Contact & Investigator
Study Director
STUDY DIRECTOR
Takeda
Frequently Asked Questions
Who can join the NCT05113095 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, studying Crohn's Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05113095 currently recruiting?
Yes, NCT05113095 is actively recruiting participants. Contact the research team at medinfoUS@takeda.com for enrollment information.
Where is the NCT05113095 trial being conducted?
This trial is being conducted at Tokyo, Japan.
Who is sponsoring the NCT05113095 clinical trial?
NCT05113095 is sponsored by Takeda. The principal investigator is Study Director at Takeda. The trial plans to enroll 275 participants.
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