Ignite Creation Date:
2024-05-06 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 2:14 PM
Study NCT ID:
NCT05067166
Status:
AVAILABLE
Last Update Posted:
2024-05-03
First Post:
2021-09-23
Brief Title:
Open-Label Expanded Access for Ebola-Infected Patients to Receive Human mAb Ansuvimab as Therapeutic or for HR PEP
Sponsor:
Ridgeback Biotherapeutics LP
Organization:
Ridgeback Biotherapeutics LP
Study Overview
Official Title:
Open-Label Expanded Access Protocol of a Human Monoclonal Antibody Ansuvimab mAb114 Administered as an Investigational Therapeutic to Ebola-Infected Patients or as a High-Risk Ebola Post-Expo
Status:
AVAILABLE
Status Verified Date:
2023-11
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:
The human monoclonal antibody mAb ansuvimab mAb114 will be provided to Ebola-infected patients as either a treatment or as PEP under expanded access Ansuvimab is administered at 50 mgkg as a single intravenous IV infusion
Detailed Description:
This is an open-label intermediate size patient population expanded access protocol EAP of the ansuvimab investigational product administered once by IV infusion at a dose of about 50 mgkg weight-based dosing Assessment of safety will include clinical observation and monitoring following administration Patients will be monitored and assessed daily through discharge for safety and the incidence of serious adverse events SAEs and AEs that by clinical judgement are atypical for EVD and any AEs that occur during product infusions Blood will be collected for ansuvimab PK assessment sGP quantification and RT-PCR evaluation of viral load by available assay A blood sample for Ebolavirus viral load measurement is collected before mAb114 administration and at subsequent study timepoints per the Schedule of Evaluations Subjects will be followed for up to 3 weeks after the product administration or until discharge from the Ebola Treatment Unit ETU whichever is later Survival status for infected patients andor EVD disease status for PEP subjects will be recorded as applicable Ansuvimab will be provided for expanded access in the DRC and can be used in any DRC Ebolavirus Zaire outbreak location as authorized by the DRC Ministry of Health and the local Institutional Review Board
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| Ansuvimab EAP-DRC-2021-INRB | OTHER | Ridgeback Biotherapeutics | None |