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

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ClinicalTrials.gov Identifier: NCT03576690
Expanded Access Status : Available
First Posted : July 3, 2018
Last Update Posted : July 27, 2020
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

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

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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



Intervention Details:
  • Biological: REGN3470-3471-3479
    Other Name: REGN-EB3

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


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: Clinical Trials Administrator 844-734-6643 clinicaltrials@regeneron.com

Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals
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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: July 27, 2020
Last Verified: July 2020
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
Hemorrhagic Fevers, Viral
RNA Virus Infections
Filoviridae Infections
Mononegavirales Infections