Study of Obeldesivir as Postexposure Prophylaxis for Marburg Virus Disease
- Conditions
- Postexposure Prophylaxis Marburg Virus Disease
- Interventions
- Drug: obeldesivir
- Registration Number
- NCT06682234
- Lead Sponsor
- Gilead Sciences
- Brief Summary
The goal of this clinical study is to learn more about the study drug, obeldesivir (ODV), and how safe and effective it is preventing Marburg virus disease (MVD) in participants with known or suspected exposure to Marburg virus (MARV).
The primary objective is to evaluate the safety and tolerability of ODV for MARV postexposure prophylaxis (PEP).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 400
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Able to understand and give written informed consent and comply with treatment and follow up.
-
Individuals who are of childbearing potential and engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception
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Known or suspected high-risk exposure to MARV within 21 days of Day 1. High-risk exposure may include the following:
- Direct contact with bodily fluids from a confirmed MVD case.
- Needle stick injury with a needle potentially contaminated with MARV.
- Prolonged exposure to an individual with MARV infection or MVD without (adequate) personal protective equipment.
Key
- Individuals with plans to breastfeed during the study period and 21 days following the last dose of study intervention. World Health Organization guidance on breastfeeding should be followed.
- Known hypersensitivity to the study intervention, its metabolites, or formulation excipient.
- Known MARV reverse transcriptase-polymerase chain reaction (RT-PCR) positivity or symptomatic MVD as attributed by the investigator.
- Known moderate or severe renal impairment or known estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m^2.
- Decompensated cirrhosis (Child-Pugh Class C), acute liver injury/failure (eg, new onset [< 2 weeks] of easy bruising, jaundice, ascites, hepatic encephalopathy, asterixis), and/or known alanine aminotransferase ≥5 × upper limit of normal.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Obeldesivir (ODV) obeldesivir Participants will receive ODV for 10 days
- Primary Outcome Measures
Name Time Method Percentage of Participants Experiencing Serious Adverse Events (SAEs) First dose date up to 29 Days
- Secondary Outcome Measures
Name Time Method Proportion of Participants with Symptomatic MVD by Day 29 Up to 29 Days Proportion of Participants with Polymerase Chain Reaction (PCR)-Confirmed MARV Infections by Day 29 Up to 29 Days Proportion of Participants with All-Cause Death by Day 29 Up to 29 Days