Last updated on May 2020

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

Brief description of study

The purpose of this study is to evaluate the long-term safety of a single dose of darvadstrocel in participants with Crohn's disease (CD) and complex perianal fistula by evaluation of adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs).

Detailed Study Description

The drug being tested in this study is called darvadstrocel (Cx601). Darvadstrocel is being tested to treat people who have Crohn's disease (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.

Clinical Study Identifier: NCT04075825

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CHU de Clermont-Ferrand - Estaing

Clermont-Ferrand cedex 1, France
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Recruitment Status: Open

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