This study is in progress, not accepting new patients

Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula

a study on Crohn's Disease Inflammatory Bowel Disease Fistula

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

Summary

The main aim is to follow-up on long term side effect and symptom improvement of Darvadstrocel in the treatment of complex perianal fistula in adults. Participants will not receive any drug in this study.

Official Title

A Follow-up of a Phase 3 Study to Evaluate the Long-term Safety and Efficacy of Darvadstrocel in the Treatment of Complex Perianal Fistula in Subjects With Crohn's Disease Who Have Participated in ADMIRE II Study

Details

The drug being tested in this study is called darvadstrocel (Cx601). Darvadstrocel is being tested to treat people who have CD and complex perianal fistula. This study will look at the long-term safety and efficacy of darvadstrocel in the treatment of complex perianal fistula in CD. The study will enroll approximately 150 patients. Participants who received darvadstrocel or placebo in study ADMIRE-CD II (Cx601-0303, NCT03279081) and who have completed the 52 weeks of the study will be enrolled in this long-term extension study. This multi-center trial will be conducted worldwide. The overall time to participate in this study is 104 weeks. Participants will make multiple visits to the clinic and will be contacted by telephone every 3 months for a follow-up assessment.

Keywords

Crohn's Disease Complex Perianal Fistula Drug therapy Crohn Disease Rectal Fistula Fistula Darvadstrocel

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Has participated in and completed the ADMIRE-CD II (NCT03279081) study (i.e., did not discontinue).

You CAN'T join if...

  1. Has been more than 3 months since the participant completed the ADMIRE-CD II study.

Locations

  • University of California San Francisco
    San Francisco California 94115 United States
  • Cedar-Sinai Medical Center
    West Hollywood California 90048 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Takeda
ID
NCT04075825
Phase
Phase 3 research study
Study Type
Interventional
Participants
At least 151 people participating
Last Updated