ong-term Follow-up Study With Darvadstrocel in the Treatment of Complex PerianalFistula

Phase 1

Conditions: Perianal fistulising Crohn´s disease
MedDRA version: 20.0Level: PTClassification code 10002156Term: Anal fistulaSystem Organ Class: 10017947 - Gastrointestinal disorders
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2019-000333-39-HU

Lead Sponsor: Millennium Pharmaceuticals, Inc (MPI)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 150

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the long-term safety of a single dose of darvadstrocel in subjects with CD and complex perianal fistula by evaluation of AEs, serious adverse events (SAEs), and adverse events of special interest (AESIs).<br>;Secondary Objective: To evaluate the long-term efficacy of a single dose of darvadstrocel for the treatment of complex perianal fistula(s) in subjects with CD.<br>;Primary end point(s): - AEs.<br>- SAEs.<br>- Specific AESIs:<br>– Immunogenicity/alloimmune reactions.<br>– Tumorgenicity.<br>– Ectopic tissue formation.<br>;Timepoint(s) of evaluation of this end point: Examinations/assessments at week 0, 52, 104.<br>Telephone calls every 3 months.

Secondary Outcome Measures