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NCT05113095Recruiting

A Survey of Darvadstrocel in People With Crohn's Disease

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)

Source: ClinicalTrials.gov · Last updated 17 Nov 2025

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
275 (estimated)
First submitted
5 Nov 2021
Start date
30 Nov 2021
Primary completion date
31 Dec 2029
Lead sponsor
Takeda
NCT number
NCT05113095

What you commit to

  • Study type: Observational
  • Planned participants: 275
  • From 30 Nov 2021 to the primary completion date, 31 Dec 2029
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
-
Coordinator of this site? Confirm its status
TokyoJapanRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.