A Survey of Darvadstrocel in People with Crohn's Disease

Last updated: November 26, 2024
Sponsor: Takeda
Overall Status: Active - Recruiting

Phase

N/A

Condition

Colic

Bowel Dysfunction

Ulcerative Colitis

Treatment

Darvadstrocel

Clinical Study ID

NCT05113095
Alofisel-5008
  • Ages > 20
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria All patients with complex perianal fistulas in Crohn's Disease who received Darvadstrocel will be included.

Exclusion Criteria None

Study Design

Total Participants: 275
Treatment Group(s): 1
Primary Treatment: Darvadstrocel
Phase:
Study Start date:
November 30, 2021
Estimated Completion Date:
December 31, 2029

Connect with a study center

  • Takeda selected site

    Tokyo,
    Japan

    Active - Recruiting

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