Ignite Creation Date:
2024-05-06 @ 3:12 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04550130
Status:
RECRUITING
Last Update Posted:
2022-11-08
First Post:
2020-04-09
Brief Title:
Dose-Evaluation Study of the Efficacy and Safety of TLA Gut Leukapheresis Treatment in Patients With Ulcerative Colitis
Sponsor:
TLA Targeted Immunotherapies AB
Organization:
TLA Targeted Immunotherapies AB
Study Overview
Official Title:
An Open-label Randomised Multi-centre Dose-Evaluation Study of the Efficacy and Safety of TLA Gut Leukapheresis Treatment in Patients With Ulcerative Colitis
Status:
RECRUITING
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
An open-label randomised multi-centre dose evaluation study of the efficacy and safety of TLA Gut leukapheresis treatment in patients with UC The aim of this trial is to evaluate the efficacy and safety of two different TLA Gut dose regimens in patients with acute exacerbation of UC Enrolled patients will participate in a 6-week treatment phase and a 20- week follow-up phase The treatment phase consists of two periods 2 weeks in which patients will undergo two treatment sessions per week followed by 4 weeks of a single treatment session per week The follow-up phase consists of 2 visits one visit at week 7 and the last visit at week 26 Telephone visits will be conducted between these visits In all a patient will undergo 8 treatment visits and 2 follow-up visits Only patients not having experienced an earlier recurrence will participate in the follow-up phase
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None