EUCTR2019-000333-39-BEActive, not recruitingPhase 1
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 - Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula
Takeda Development Center Americas, Inc0 sites150 target enrollmentStarted: January 21, 2020Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 150
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Subject eligibility is determined according to the following criteria before entry into the study:
- •1. In the opinion of the investigator, the subject is capable of understanding and complying withprotocol requirements.
- •2. The subject or, when applicable, the subject’s legally acceptable representative signs and dates a written ICF and any required privacy authorization before the initiation of any study procedures.
- •3. The subject has participated in and completed the ADMIRE-CD II study (ie, did not discontinue).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 124
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 26
Exclusion Criteria
- •Subjects will not be eligible for inclusion in the study if:
- •1. It has been more than 3 months since the subject completed the ADMIRE-CD II study.
- •2. Subjects are currently receiving, have received any investigational drug in the last 3 months before the inclusion in the study, or are planning to receive any investigational drug during the duration of this LTE study, except for prior participation in the ADMIRE-CD II study.
Investigators
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