StudyFinder
CLINPRT-7: Intermediate Patient Population Expanded Access Protocol for MBP134 for Patients with Sudan Virus Disease (SVD)
Recruiting
The purpose of this open-label Expanded Access Protocol (EAP) is to provide access to MBP134, for treatment of Sudan Virus Disease (SVD). Patients will receive a single IV infusion of 50 mg/kg MBP134. Patients will be monitored and assessed daily through discharge for safety and the incidence of serious adverse events (SAEs), and of all adverse events (AEs) during infusions.
Male or Female
Not specified
Inclusion Criteria:
• people of any age who have a documented positive RT-PCR for Sudan Virus Disease (SVD) in the last 10 days
• OR a documented positive RT-PCR test for SUDV more than 10 days ago but continue to have symptoms of SVD
• OR acute symptoms compatible with SVD and a close contact with some who has RT-PCR confirmed SVD
• OR Infants born to mothers who have a 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
• women of who are of child-bearing age must use highly effective contraception for 90 days after receiving the medication
Exclusion Criteria:
• any medical condition that, in the opinion of the physician, would unreasonably increase risk of side effects (study staff will assess)
Infectious Diseases, Rare Diseases
Sudan Virus Disease, SVD
Jessica Gieseke - giese141@umn.edu
Susan Kline, MD
SITE00001888