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

November 14, 2023 updated by: Ridgeback Biotherapeutics, LP

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

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

Study Overview

Status

Available

Conditions

Intervention / Treatment

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 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 Type

Expanded Access

Expanded Access Type

  • Individual Patients
  • Intermediate-size Population

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Description

Inclusion Criteria:

  • Male or female with laboratory confirmed (based on local standard of care) EBOV infection or with recent high-risk EBOV exposure as determined by a treating Physician or designee.
  • Able to provide proof of identity to the satisfaction of the clinical team
  • Able and willing to complete the informed consent process personally, or if the patient is unable to do so, then informed consent completed by a legally-authorized representative according to local laws and regulations.

Exclusion Criteria:

- Any medical condition that, in the opinion of the Treating Physician, would place the patient at an unreasonably increased risk through participation in this treatment protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ridgeback Biotherapeutics, LP

Collaborators

Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo

Investigators

  • Principal Investigator: Jean Jacques Muyembe-Tamfum, MD,PhD, INRB

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

September 23, 2021

First Submitted That Met QC Criteria

September 23, 2021

First Posted (Actual)

October 5, 2021

Study Record Updates

Last Update Posted (Estimated)

November 16, 2023

Last Update Submitted That Met QC Criteria

November 14, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ansuvimab EAP-2020-DRC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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