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A Survey of Darvadstrocel in People With Crohn's Disease

NCT05113095 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 275

Last updated 2025-11-17

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

Darvadstrocel

Darvadstrocel injection

Sponsors & Collaborators

Principal Investigators

  • Study Director · Takeda

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-30
Primary Completion
2029-12-31
Completion
2029-12-31

Countries

  • Japan

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05113095 on ClinicalTrials.gov