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:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2025-12-24 @ 4:16 PM
NCT ID:
NCT06156566
Eligibility Criteria:
Inclusion Criteria:
* Polymerase Chain Reaction (PCR) /Nucleic Acid Amplification Test (NAAT) -confirmed mpox infection
* The presence of active skin or mucosal lesion(s)
* Signed Informed Consent Form
Exclusion Criteria:
* Age \<18 years.
* Body weight \<40 kg
* Pregnant and breastfeeding patients are not eligible for inclusion in this study.
* Lack of mental capacity to provide informed consent
* Trial participation is considered not in the best interest of patient
* Known hypersensitivity to the active substance or to any of the excipients of the study drug.
* Use of contraindicated treatment repaglinide. (Repaglinide, an oral treatment for diabetes mellitus, may be discontinued while taking study treatment with the agreement of the patient's general practitioner, who may start alternate diabetes treatment if considered necessary.)
* Previous, current or planned use of another investigational drug (tecovirimat) at any point during study participation.
* The patient's own doctor considers there to be a definite indication for the patient to receive tecovirimat or the local guidelines establish that tecovirimat treatment should be initiated
* The patient's own doctor considers there to be a definite contraindication to the patient receiving tecovirimat.
* The patient suffers from hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06156566
Study Brief:
Protocol Section:
NCT06156566