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A Study of Darvadstrocel for Treating Complex Perianal Fistulas in Children and Teenagers With Crohn's Disease

NCT04701411 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2025-11-13

Study results available
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Summary

A perianal fistula is an abnormal passageway that develops between the rectum and the skin near the anus. The fistula is considered complex if it branches into several openings or an abscess is also present.

The main aim of this study is to learn if complex perianal fistulas in children and teenagers close after treatment with darvadstrocel.

2 to 3 weeks before treatment with darvadstrocel, each participant will have surgery to clean the fistula and to drain any abscesses. On the day of treatment, each participant will have the fistula cleaned and will receive an injection of darvadstrocel near the fistula, under anesthetic.

For up to 1 year after treatment, participants will regularly visit the clinic for follow-up. The fistula will be examined and any side effects from the treatment will be recorded. Participants will have an MRI at one clinic visit (about 24 weeks after treatment).

Conditions

Interventions

BIOLOGICAL

Darvadstrocel

Darvadstrocel perilesional injection.

Sponsors & Collaborators

  • Takeda Development Center Americas, Inc.

    collaborator INDUSTRY

  • Takeda

    lead INDUSTRY

Principal Investigators

  • Medical Director · Takeda

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-30
Primary Completion
2025-05-07
Completion
2025-05-07

Countries

  • Israel
  • Japan
  • Netherlands
  • Poland
  • Spain

Study Locations

More Related Trials

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 NCT04701411 on ClinicalTrials.gov