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Study of Obeldesivir as Postexposure Prophylaxis for Marburg Virus Disease

Phase 2
Not yet recruiting
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
Inclusion Criteria
  • 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

  • Known or suspected high-risk exposure to MARV within 21 days of Day 1. High-risk exposure may include the following:

    1. Direct contact with bodily fluids from a confirmed MVD case.
    2. Needle stick injury with a needle potentially contaminated with MARV.
    3. Prolonged exposure to an individual with MARV infection or MVD without (adequate) personal protective equipment.

Key

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Exclusion Criteria
  • 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.

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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Obeldesivir (ODV)obeldesivirParticipants will receive ODV for 10 days
Primary Outcome Measures
NameTimeMethod
Percentage of Participants Experiencing Serious Adverse Events (SAEs)First dose date up to 29 Days
Secondary Outcome Measures
NameTimeMethod
Proportion of Participants with Symptomatic MVD by Day 29Up to 29 Days
Proportion of Participants with Polymerase Chain Reaction (PCR)-Confirmed MARV Infections by Day 29Up to 29 Days
Proportion of Participants with All-Cause Death by Day 29Up to 29 Days
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