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Open-Label Expanded Access for Ebola-Infected Patients to Receive Human mAb Ansuvimab as Therapeutic or for HR PEP

Hemorrhagic Fever, Ebola Clinical Trial

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

Clinical Trial 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 mg/kg as a single intravenous (IV) infusion

Clinical Trial 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 mg/kg (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 and/or 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05067166
Study type Expanded Access
Source Ridgeback Biotherapeutics, LP
Contact Sabue Mulangu, MD,DTMH,PhD
Phone 1 833 846 3789
Email EAP-requests@ridgebackbio.com
Status Available
Phase
View Details
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