Ignite Creation Date:
2024-05-06 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 2:18 PM
Study NCT ID:
NCT05136833
Status:
WITHDRAWN
Last Update Posted:
2022-07-13
First Post:
2021-11-10
Brief Title:
Evaluation of Efficacy and Safety of the Concomitant of RUTI Immunotherapy With the Standard Treatment in TB Patients
Sponsor:
Archivel Farma SL
Organization:
Archivel Farma SL
Study Overview
Official Title:
A Phase IIb Study to Explore the Efficacy and Safety of the Concomitant Administration of RUTI Immunotherapy With the Standard Treatment in Patients With TB
Status:
WITHDRAWN
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Covid-19 pandemia
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CONSTAN
Brief Summary:
The study is an exploratory clinical trial to evaluate the efficacy and safety of the treatment with a vaccine against tuberculosis RUTI given at the same time as standard treatment in patients with tuberculosis It is a prospective randomized 11 double-blind multicentre placebo-controlled clinical phase IIb trial
Detailed Description:
Patients will be randomized 1 1 to receive an inoculation of RUTI or placebo at the same time that standard treatment is started
The standard TB treatment will continue after RUTI or placebo administration according to SOC guidelines All the patients will be followed up 6 months after the vaccination or until the end of SOC treatment
Once all the patients have completed the week 2 follow-up a Data Safety Monitoring Board DSMB will be established to review all relevant safety and toxicity data
The standard TB treatment will continue after RUTI or placebo administration according to SOC guidelines All the patients will be followed up 6 months after the vaccination or until the end of SOC treatment
Once all the patients have completed the week 2 follow-up a Data Safety Monitoring Board DSMB will be established to review all relevant safety and toxicity data
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2021-003301-22 | EUDRACT_NUMBER | None | None |