Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-25 @ 2:38 AM
NCT ID:
NCT06682234
Eligibility Criteria:
Key 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 Ebola virus (EBOV), Sudan virus (SUDV), or Marburg virus (MARV) within 21 days of Day 1. High-risk exposure may include the following:
1. Direct contact with bodily fluids from a confirmed case.
2. Needle stick injury with a needle potentially contaminated with virus.
3. Prolonged exposure to an individual with EBOV, SUDV, or MARV infection or disease without (adequate) personal protective equipment.
Key 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 EBOV, SUDV, or MARV reverse transcriptase-polymerase chain reaction (RT-PCR) positivity or symptomatic filovirus disease 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06682234
Study Brief:
Protocol Section:
NCT06682234