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R3470-3471-3479 (REGN-EB3) Expanded Access Protocol (EAP) for Treatment of Ebola Virus Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03576690
Expanded Access Status : Available
First Posted : July 3, 2018
Last Update Posted : May 2, 2022
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Study Description
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Brief Summary:
Provide access to REGN-EB3 for the treatment of patients with Ebola Virus Disease (EVD).

Condition or disease Intervention/treatment
Ebola Virus Disease Biological: REGN3470-3471-3479

Study Design
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Study Type : Expanded Access
Expanded Access Type : Individual Patients
Official Title: Expanded Access Protocol for Emergency Use of REGN3470-3471-3479 for the Treatment of Ebola Virus Disease

Resource links provided by the National Library of Medicine


Interventions
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Intervention Details:
  • Biological: REGN3470-3471-3479
    Other Names:
    • REGN-EB3
    • Inmazeb®
    • atoltivimab, maftivimab, and odesivimab
Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Criteria

Key Inclusion Criteria:

  • Males or females in an Ebola endemic region with documented positive polymerase chain reaction (PCR) for Ebola virus infection who are symptomatic
  • Ability to provide informed consent personally or by a legal representative if the patient is unable to do so, based on local laws and regulations
  • REGN-EB3 can be administered to pregnant women infected with Zaire ebolavirus, as defined in the protocol
  • Children of any age will be eligible for enrollment, as defined in the protocol
  • Neonates born to an infected mother who has not yet cleared the Ebola virus are eligible for enrollment, as defined in the protocol

Key Exclusion Criteria:

  • Negative EBOV diagnostic test result
  • A patient who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol
  • Any serious medical condition that, in the opinion of the site investigator, would place the patient at an unreasonable increased risk through participation in this study, including any past or concurrent conditions
  • Eligible for an ongoing randomized clinical trial with REGN-EB3

NOTE: Other protocol defined inclusion / exclusion criteria apply

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03576690


Contacts
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Contact: Requests for compassionate use must be initiated by a treating physician. Physicians should contact 844-734-6643 compassionateuserequests@regeneron.com

Sponsors and Collaborators
Regeneron Pharmaceuticals
More Information
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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03576690    
Other Study ID Numbers: R3470-3471-3479-EBOV-1846
First Posted: July 3, 2018    Key Record Dates
Last Update Posted: May 2, 2022
Last Verified: April 2022
Keywords provided by Regeneron Pharmaceuticals:
Positive Ebola Virus (EBOV) diagnostic test
symptomatic
Additional relevant MeSH terms:
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Virus Diseases
Hemorrhagic Fever, Ebola
Infections
Hemorrhagic Fevers, Viral
 RNA Virus Infections
Filoviridae Infections
Mononegavirales Infections