Actively Recruiting
A Study of Efficacy, Safety, Tolerability of LXE408 in Participants With Chronic Chagas Disease.
Led by Novartis Pharmaceuticals · Updated on 2026-03-30
130
Participants Needed
19
Research Sites
281 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Efficacy, Safety, Tolerability of LXE408 in Participants With Chronic Chagas Disease.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 218 years to 260 years old
- Confirmed diagnosis of T. cruzi infection
- Determined to be in the chronic phase of Chagas disease
- Provided written informed consent and understand the study
- Eligible and able to comply with benznidazole treatment guidelines
- Able and willing to communicate with study staff and follow study requirements
You will not qualify if you...
- Signs or symptoms of acute Chagas disease at screening
- Previous treatment with benznidazole or nifurtimox
- Moderate or severe gastrointestinal disease related to Chagas disease
- Weight less than 50 kg or greater than 90 kg at screening
- Contraindications to MRI if site involves MRI assessments
- Any clinically significant disease that risks safety or study compliance
- Significant cardiovascular conditions including unstable ischemic heart disease, severe heart failure, or arrhythmias
- Known or suspected ongoing infections like tuberculosis, leishmaniasis, severe malaria, or HIV (except controlled HIV with CD4 2500)
- History or current malignancy within 5 years except treated basal cell carcinoma, actinic keratosis, cervical carcinoma in situ, or non-invasive malignant colon polyps
- Medical conditions affecting drug absorption or metabolism including pancreatic injury or pancreatitis
- Liver disease or abnormal liver function tests beyond specified limits
- Kidney disease indicated by creatinine or microalbuminuria or eGFR below 60 mL/min
- Abnormal hematology results outside protocol thresholds
- Current or expected use of prohibited medications
- Use of benznidazole in blinded arms before unblinding
- Use of other investigational drugs at dosing
- History of multiple or recurring allergies to study drugs
- History of drug abuse or unhealthy alcohol use within 12 months
- Pregnant or breastfeeding women
- Women of childbearing potential not using effective contraception
- Inability to comply with study procedures or visit schedules
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 19 locations
1
Olive View UCLA Educ and Res Ins
Sylmar, California, United States, 91342
Actively Recruiting
2
University of Florida Shands
Gainesville, Florida, United States, 32610-0486
Actively Recruiting
3
Boston Medical Center
Boston, Massachusetts, United States, 02118
Actively Recruiting
4
Baylor College of Medicine
Houston, Texas, United States, 77030-3411
Actively Recruiting
5
Novartis Investigative Site
CABA, Buenos Aires, Argentina, 1407
Actively Recruiting
6
Novartis Investigative Site
CABA, Buenos Aires, Argentina, C1221ADC
Actively Recruiting
7
Novartis Investigative Site
Corrientes, Argentina, W3400CDS
Actively Recruiting
8
Novartis Investigative Site
Córdoba, Argentina, X5016KEH
Actively Recruiting
9
Novartis Investigative Site
Formosa, Argentina, P3600KGC
Actively Recruiting
10
Novartis Investigative Site
Montes Claros, Minas Gerais, Brazil, 39401-001
Actively Recruiting
11
Novartis Investigative Site
Recife, Pernambuco, Brazil, 50100-060
Actively Recruiting
12
Novartis Investigative Site
Rio de Janeiro, Rio de Janeiro, Brazil, 21040-360
Actively Recruiting
13
Novartis Investigative Site
São Caetano do Sul, São Paulo, Brazil, 09521-160
Actively Recruiting
14
Novartis Investigative Site
Barranquilla, Atlántico, Colombia, 080005
Actively Recruiting
15
Novartis Investigative Site
Yopal, Casanare Department, Colombia, 850009
Actively Recruiting
16
Novartis Investigative Site
Bogotá, Colombia, 110131
Actively Recruiting
17
Novartis Investigative Site
Bogotá, Colombia, 111411
Actively Recruiting
18
Novartis Investigative Site
Floridablanca, Colombia, 681017
Actively Recruiting
19
Novartis Investigative Site
San Gil, Colombia, 684031
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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