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Tests treatment safety and results for Chagas Disease
Official title A Study of Efficacy, Safety, Tolerability of LXE408 in Participants With Chronic Chagas Disease.
ClinicalTrials.gov ID: NCT06632600
What this study is testing
What is LXE408?
LXE408 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for chagas disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- 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...
- Participants must be considered by the investigator eligible for and able to comply with local prescribing information for benznidazole
You likely can't join if
- 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 \ 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...
- Any clinically significant disease during screening that, in the opinion of the investigator, would put the safety of the participant at risk through...
See the full eligibility 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
- 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 \ 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 how well it works or safety...
- Documented history or current findings at screening of clinically significant cardiovascular conditions such as, but not limited to: unstable ischemic heart disease; NYHA Class III/IV heart failure (due to Chagas...
- Known or suspected ongoing, chronic or recurrent viral, bacterial or fungal infectious diseases including but not limited to: Tuberculosis, leishmaniasis, severe malaria, atypical mycobacterial infection, listeriosis...
- Participants with controlled HIV on antiretroviral therapy are eligible to participate if CD4 ≥ 500 at screening
- History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years prior to screening (except for basal cell carcinoma or actinic keratosis that have been...
- Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the participant during the study period
- Pancreatic injury or pancreatitis: If any single parameter of amylase or lipase exceeds 1.5x ULN at screening Participants with known recurrent pancreatitis (more than 1 episode in lifetime, from any cause) are excluded
- Liver disease or liver injury as indicated by abnormal liver function tests (LFTs): Any single parameter of ALT, AST, alkaline phosphatase must not exceed 1.5x ULN at screening Serum bilirubin must not exceed the ULN at...
- History of renal disease as indicated by creatinine level above 1.5x ULN or microalbuminuria at screening; Evidence of urinary obstruction, or difficulty in voiding at screening; evidence of congenital renal...
- Participants with screening hematology parameters outside of the thresholds
- Current use of medications prohibited by the protocol at screening and/or baseline visits, or expected use of any prohibited medication during the study treatment period
- Use of benznidazole in the blinded arms is prohibited until unblinding occurs after all participants complete Month 12.
- Use of other investigational drugs at the time of study drug dosing
- History of multiple and recurring allergies or allergy to the investigational compound/compound class being used in this study or to benznidazole
- History of drug abuse or unhealthy alcohol use within the 12 months prior to dosing
- Pregnant or nursing (lactating/breast-feeding) women
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 5 days after stopping of...
- Participants who, in the opinion of the investigator, will not be able to comply with study procedures or visits, adhere to dosing schedule, or other otherwise be in compliance with study requirements Other...
The study team makes the final eligibility decision.
Where it's taking place
- Sylmar, California, United States
- Gainesville, Florida, United States
- Boston, Massachusetts, United States
- Houston, Texas, United States
- CABA, Buenos Aires, Argentina
- Caba, Argentina
- Corrientes, Argentina
- Córdoba, Argentina
- Formosa, Argentina
- Montes Claros, Minas Gerais, Brazil
- Recife, Pernambuco, Brazil
- Rio de Janeiro, Rio de Janeiro, Brazil
- São Caetano do Sul, São Paulo, Brazil
- Barranquilla, Atlántico, Colombia
- Yopal, Casanare Department, Colombia
- Bogotá, Colombia
- Floridablanca, Colombia
- San Gil, Colombia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sylmar, California, United States; Gainesville, Florida, United States; Boston, Massachusetts, United States; Houston, Texas, United States; CABA, Buenos Aires, Argentina; Caba, Argentina and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.