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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
LXE408
DrugLXE408 administered by oral route
Placebo
DrugPlacebo administered by oral route
Benznidazole
DrugBenznidazole administered by oral route (administered as standard of care)
Treatment groups
130 Participants
are divided into 4 treatment groupsGroup A: LXE408 28 daysExperimental treatment 0 interventions
Group B: LXE408 14 days and Placebo 14 daysExperimental treatment 2 interventions
Group C: Placebo 28 daysPlacebo comparator 1 intervention
Group D: Benznidazole 60 daysActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Presence or absence of sustained parasitological clearance using polymerase chain reaction (PCR) results over 6 months - LXE408 28 days versus placebo.
The parasitological load will be measured using polymerase chain reaction (PCR) at 2 months, 4 months, and at 6 months. At each timepoint, multiple samples are evaluated. The participant will be considered negative at a visit if the parasite is not detectable in all samples at a visit and positive if the parasite level is detectable in at least one sample. Sustained parasitological clearance is achieved if participant is negative at all 3 visits.
Time frame
At Months 2, 4, and 6Secondary outcomes
1
Presence or absence of sustained parasitological clearance using polymerase chain reaction (PCR) results over 6 months - LXE408 -14 days versus placebo
The parasitological load will be measured using polymerase chain reaction (PCR) at 2 months, 4 months, and at 6 months. At each timepoint, multiple samples are evaluated. The participant will be considered negative at a visit if the parasite is not detectable in all samples at a visit and positive if the parasite level is detectable in at least one sample. Sustained parasitological clearance is achieved if participant is negative at all 3 visits.
Time frame
At Months 2, 4, and 62
Presence or absence of sustained parasitological clearance using polymerase chain reaction (PCR) results over 6 months-LXE408 - 28 days and 14 days versus benznidazone
The parasitological load will be measured using polymerase chain reaction (PCR) at 2 months, 4 months, and at 6 months. At each timepoint, multiple samples are evaluated. The participant will be considered negative at a visit if the parasite is not detectable in all samples at a visit and positive if the parasite level is detectable in at least one sample. Sustained parasitological clearance is achieved if participant is negative at all 3 visits.
Time frame
At Months 2, 4, and 63
Presence or absence of early parasitological clearance
The parasitological load will be measured using polymerase chain reaction (PCR). The participant will be considered negative at a visit if the parasite is not detectable in all samples at a visit and positive if the parasite level is detectable in at least one sample.
Time frame
At Day 7, 14 and 284
Presence or absence of sustained parasitological clearance over 12 months by PCR testing
The parasitological load will be measured using polymerase chain reaction (PCR). The participant will be considered negative at a visit if the parasite is not detectable in all samples at a visit and positive if the parasite level is detectable in at least one sample. Sustained parasitological clearance is achieved if participant is negative at all subsequent visits.
Time frame
12 MonthsSponsors and contacts
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Source ClinicalTrials.gov