A Study of Efficacy, Safety, Tolerability of LXE408 in Participants With Chronic Chagas Disease. (NCT06632600) | Clinical Trial Compass
RecruitingPhase 2
A Study of Efficacy, Safety, Tolerability of LXE408 in Participants With Chronic Chagas Disease.
United States, Argentina130 participantsStarted 2025-04-28
Plain-language summary
This study is to investigate the ability of LXE408 to clear or reduce the level of parasites in the blood of people with chronic Chagas disease. Participants must have chronic Chagas disease without severe organ dysfunction.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion Criteria:
* Male or female participants aged ≥ 18 years to ≤ 60 years old
* Confirmed diagnosis of T. cruzi infection
* History that participant has been determined to be in chronic phase of CD
* Written informed consent must be obtained before any assessment is performed, and participants should express understanding of the consent form and the study
* Participants must be considered by the investigator eligible for and able to comply with local prescribing information for benznidazole
* Ability and willingness to communicate well with the investigator/study site and comply with requirements of the study
Exclusion Criteria:
* Signs (on physical examination) and/or symptoms of CD in the acute phase as determined by the investigator at screening
* History of CD treatment with benznidazole or nifurtimox at any time in the past
* History of and/or current (at screening) symptoms or signs (physical examination findings) of moderate or severe CD-related gastrointestinal disease
* Participants who weigh \< 50 kg or \>90kg at screening
* At sites conducting the MRI assessments, participants may participate in the overall study, but will be excluded from the MRI assessment if they have contraindications to MRI imaging
* Any clinically significant disease during screening that, in the opinion of the investigator, would put the safety of the participant at risk through participating, or which would affect the efficacy or safety analysis if the disease/condition exacerbated…
What they're measuring
1
Presence or absence of sustained parasitological clearance using polymerase chain reaction (PCR) results over 6 months - LXE408 28 days versus placebo.