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Phase 3 Study of Cx601 in Participants With Complex Perianal Fistulising Crohn's Disease

NCT03706456 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2024-06-10

Study results available
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Summary

The purpose of this study is to evaluate the efficacy of darvadstrocel for the treatment of complex perianal fistulas in adult participants with Crohn's disease over 24 weeks.

Conditions

  • Complex Perianal Fistulas in Adult Participants With Crohn's Disease

Interventions

BIOLOGICAL

Darvadstrocel

Darvadstrocel cell suspension for intralesional injection.

Sponsors & Collaborators

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-06
Primary Completion
2020-07-20
Completion
2023-02-10

Countries

  • Japan

Study Locations

More Related Trials

Entities

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 NCT03706456 on ClinicalTrials.gov