Single arm intervention study to test the efficacy of REGN-EB3 against Ebola hemorrhagic fever - REGN-EVD

Morioka Shinichiro0 sites5 target enrollmentJune 1, 2023

Overview

No summary available.

Registry

who.int

Start Date

June 1, 2023

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Morioka Shinichiro

•(1\) Persons who have given written consent to participate in the research.
•However, those who meet the conditions described in 18\.2 may participate in this research without prior consent.
•(1\) There is an immediate and obvious danger to the life of the person who is to be the subject of the specified clinical research.
•(2\) Other treatment methods cannot be expected to be sufficiently effective (even if they can be expected to be as effective as ordinary medical treatment or life\-saving treatment, etc.).
•(iii) That the Specific Clinical Research to be conducted is not in the best interests of the subject of the Clinical Research.
•(iii) It is recognized that there is a sufficient possibility of avoiding a risk to life by conducting the said Specified Clinical Research.
•(iii) The possibility of avoiding a life\-threatening situation by conducting the specified clinical research is considered sufficient.
•(iv) The anticipated disadvantages to the subjects of the Specified Clinical Research are the minimum necessary.
•(iv) The anticipated disadvantages to the person who should be the subject of the specified clinical research are the minimum necessary.
•(v) It is not possible to immediately contact the person who is to be the surrogate.

•1\) Subjects deemed inappropriate for inclusion in the study by the Principal Investigator or Research Supervisor
•2\) Patients for whom administration of the drug is considered inappropriate based on the attached document or other documents equivalent to the investigational new drug summary
•3\) Patients with a history of serious hypersensitivity to this drug