Protocol Details
An Intermediate Patient Population Expanded Access Protocol for MBP091 for Patients with Marburg Virus Disease (MVD)
This study is currently recruiting participants.
Summary
Number |
002305-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: 120 Years |
Referral Letter Required |
Yes |
Population Exclusion(s) |
Neonates |
Keywords |
Marburg Virus Disease;
Expanded Access;
MBP091 |
Recruitment Keyword(s) |
None |
Condition(s) |
Marburg Virus Disease |
Investigational Drug(s) |
MBP091
|
Investigational Device(s) |
None |
Intervention(s) |
None |
Supporting Site |
National Institute of Allergy and Infectious Diseases |
Study Design:
This is a multicenter open-label intermediate sized patient population expanded access protocol to provide access to MBP091 for MVD treatment.
Patients will receive a single IV infusion of 100 mg/kg of MBP091. Patients will be monitored and assessed daily through discharge for safety, the incidence of serious adverse events (SAEs), and for adverse events (AEs) occurring during the infusion. Patients will be asked to return to the clinic for a 29-day follow-up visit for safety assessments and documentation of clinical outcome when feasible. Additional monitoring will be performed at investigator discretion.
Study Objectives:
Primary Objective:
-To provide MBP091 to patients with confirmed or suspected MVD
Secondary Objective:
-To evaluate the safety of one IV infusion of 100 mg/kg of MBP091
Study Endpoints:
Primary Endpoint:
-Not applicable
Secondary Endpoints:
-Tabulation of serious adverse events
-Tabulation of adverse events occurring during infusion
Eligibility
INCLUSION CRITERIA:
1. Males or females of any age with a documented positive RT-PCR test for Marburg virus (MARV) within the last 10 days
Or
Males or females of any age with a documented positive RT-PCR test for Marburg virus (MARV) in >10 days but with continued symptoms of MVD
Or
Males or females of any age with acute MVD symptoms and a known close contact with a RT-PCR confirmed MVD patient
Or
Infants born to mothers with positive RT-PCR results for MARV within 10 days of birth or with a documented positive RT-PCR test
for MARV in >10 days but with ongoing symptoms of MVD. Note: infants born to mothers with positive RT-PCR results should be treated as soon as possible. The infant does not need to have a positive RT-PCR result to receive treatment.
2. 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.
3. 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 MBP091. All sexually active men must be willing to use condoms for at least 90 days after MBP091 treatment.
EXCLUSION CRITERIA:
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: