Postauthorization Safety Study of Darvadstrocel Repeat Administration
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Complex Perianal Fistula
- Crohn's Disease
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The biological being tested in this study is called darvadstrocel (Alofisel). This study is examining the long-term safety and efficacy of a repeat dose of Darvadstrocel in people who have Crohn's Disease and Complex Perianal Fistula. The study will enroll approximately 50 patients. Participants wil...
The biological being tested in this study is called darvadstrocel (Alofisel). This study is examining the long-term safety and efficacy of a repeat dose of Darvadstrocel in people who have Crohn's Disease and Complex Perianal Fistula. The study will enroll approximately 50 patients. Participants will be assigned to one treatment group to receive: • Darvadstrocel 120 million cells All participants would be allowed to receive one repeat dose of darvadstrocel in the whole study. This multi-center trial will be conducted worldwide. The overall time to participate in this study is approximately 3 years. Participants will make multiple visits to the clinic.
Tracking Information
- NCT #
- NCT04118088
- Collaborators
- Not Provided
- Investigators
- Study Director: Medical Director Clinical Science Takeda
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