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RECRUITING
NCT05113095

A Survey of Darvadstrocel in People With Crohn's Disease

Sponsor: Takeda

View on ClinicalTrials.gov

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.

Official title: Postmarketing Surveillance Registry to Evaluate Safety and Efficacy of Darvadstrocel for the Treatment of Complex Perianal Fistulas in Crohn's Disease Patients (J-INSPIRE) (All-case Surveillance)

Key Details

Gender

All

Age Range

20 Years - Any

Study Type

OBSERVATIONAL

Enrollment

275

Start Date

2021-11-30

Completion Date

2029-12-31

Last Updated

2025-11-17

Healthy Volunteers

No

Conditions

Interventions

BIOLOGICAL

Darvadstrocel

Darvadstrocel injection

Locations (1)

Takeda selected site

Tokyo, Tokyo, Japan