A Study of Efficacy, Safety, Tolerability of LXE408 in Participants With Chronic Chagas Disease.
ConditionChagas Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-60
SponsorNovartis Pharmaceuticals
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- LXE408
- Placebo
- Benznidazole
Treatment groups
130 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov