Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06389474
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-04-25
Brief Title:
Efficacy of INM004 in Children With STEC-HUS
Sponsor:
Inmunova SA
Organization:
Inmunova SA
Study Overview
Official Title:
A Phase III Study to Evaluate the Efficacy of INM004 Shiga Antitoxin in Pediatric Patients With Shiga Toxin-producing Escherichia Coli-associated Hemolytic Uremic Syndrome
Status:
RECRUITING
Status Verified Date:
2024-08
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:
The objectives of this study are to evaluate the efficacy safety and pharmacokinetics of INM004 in pediatric patients with Hemolytic Uremic Syndrome associated to infection by Shiga toxin-producing Escherichia coli STEC-HUS
Detailed Description:
The primary objective will be to evaluate the efficacy of INM004 added to the standard of care as a treatment for STEC-HUS in the amelioration of renal function
Secondary objectives
To evaluate the efficacy of INM004 in the reduction of mortality
To evaluate the efficacy of INM004 in the prevention and reduction of extrarenal complications
To evaluate the efficacy of INM004 in the improvement of TMA laboratory parameters
To evaluate the efficacy of INM004 in the reduction of hospital stay days
To evaluate the safety of INM004
To evaluate the pharmacokinetics of INM004
To evaluate the kinetics of Stx
Secondary objectives
To evaluate the efficacy of INM004 in the reduction of mortality
To evaluate the efficacy of INM004 in the prevention and reduction of extrarenal complications
To evaluate the efficacy of INM004 in the improvement of TMA laboratory parameters
To evaluate the efficacy of INM004 in the reduction of hospital stay days
To evaluate the safety of INM004
To evaluate the pharmacokinetics of INM004
To evaluate the kinetics of Stx
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?:
False
Is an FDA AA801 Violation?:
None