Protocol Details
Intermediate Patient Population Expanded Access Protocol for MBP134 for Patients with Sudan Virus Disease (SVD)
This study is currently recruiting participants.
Summary
Number |
001957-I |
Sponsoring Institute |
National Institute of Allergy and Infectious Diseases (NIAID) |
Recruitment Detail |
Type: Enrolling by Invitation
Gender: Male & Female
Min Age: 2 Years
Max Age: 100 Years |
Referral Letter Required |
Yes |
Population Exclusion(s) |
Neonates |
Keywords |
Sudan Virus Disease;
Expanded Access;
MBP134 |
Recruitment Keyword(s) |
None |
Condition(s) |
Sudan Virus Disease |
Investigational Drug(s) |
MBP134
|
Investigational Device(s) |
None |
Intervention(s) |
None |
Supporting Site |
National Institute of Allergy and Infectious Diseases |
Background:
Sudan virus disease (SVD) is a serious illness caused by Sudan ebolavirus (SUDV) found in Central and Eastern Africa. Symptoms include high fever, fatigue, and body aches, progressing to bleeding, organ failure, and death. About 50% of people who contract SVD will die. As yet there is no proven treatment for SVD. Doctors can offer only supportive care for the symptoms.
Objective:
To test a new drug (MBP134) in people with SVD or suspected of having SVD.
Eligibility:
People age 2 and older who test positive for SUDV. Also eligible are people with symptoms of SVD who had close contact with someone who tested positive for this disease.
Design:
Participants will be screened. They will have a physical exam with blood tests. They will have tests of their heart function.
MBP134 is given through a tube attached to a needle inserted into a vein in the arm. Participants will enter the hospital to receive 1 dose of MBP134. Blood tests will be repeated, and their blood pressure, pulse, and breathing will be monitored frequently during their stay. They will remain in the hospital for observation until they are cleared to go home. They may need to stay several days.
Participants will return to the clinic 29 days after the treatment. They will answer questions about their health and any adverse effects they experienced.
Eligibility
INCLUSION CRITERIA:
-Males or females of any age with a documented positive RT-PCR test for SUDV within the last 10 days
Or
Males or females of any age with a documented positive RT-PCR test for SUDV in >10 days but with continued symptoms of SVD
Or
Males or females of any age with acute SVD-compatible symptoms and a known close contact with a RT-PCR confirmed SVD patient
Or
Infants born to mothers with positive RT-PCR results for SUDV within 10 days of birth or with a documented positive RT-PCR test for SUDV in >10 days but with ongoing symptoms of SVD. Note: infants born to mothers with SVD should be treated as soon as possible. The infant does not need to have SVDcompatible symptoms or a positive RT-PCR result to receive treatment.
-Ability to provide informed consent personally, or by a legally authorized representative [per applicable local laws and regulations] if the patient is unable to do so.
-All females of childbearing potential must be willing to use highly effective [i.e., absolute abstinence from potentially reproductive sexual activity, hormonal, intrauterine device (IUD), surgical or multiple barrier/combined] methods of contraception, from time of enrollment through at least 90 days after receiving MBP134. All sexually active men must be willing to use condoms for at least 90 days after MBP134 treatment.
EXCLUSION CRITERIA:
The exclusion criteria for this study are as follows:
Any medical condition that, in the opinion of the site investigator, would place the patient at an unreasonably increased risk through participation in this treatment protocol.
Citations:
Not Provided
Contacts: