RECRUITING

A Study of Efficacy, Safety, Tolerability of LXE408 in Participants With Chronic Chagas Disease.

Conditions

Chagas Disease LXE408 Chronic Chagas disease Chronic indeterminate Chagas disease Chronic Chagas disease without severe organ dysfunction CICD Chronic CD Trypanosoma cruzi

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Randomized, Participant- and Investigator-blinded, Controlled, Parallel Group Study to Assess the Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LXE408 in Participants With Chronic Chagas Disease Without Severe Organ Dysfunction.

Quick Facts

Study Start:2025-04-28

Study Completion:2030-09-21

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06632600

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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 \< 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 during the study, or would compromise participant compliance or preclude completion of the study * 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 disease or other conditions); arrhythmias * 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, aspergillosis, or endemic mycoses, and/or documented positivity for human immunodeficiency virus (HIV) infection. * 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 treated with no evidence of recurrence in the past 3 months, carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed) * 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): * 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 abnormalities with known effect on renal function; calculated eGFR \<60 mL/min (\<0.835 mL/s) using the CKD-EPI formula for adults * 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 investigational drug and benznidazole * 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

Inclusion Criteria

Exclusion 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 \< 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 during the study, or would compromise participant compliance or preclude completion of the study
* 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 disease or other conditions); arrhythmias
* 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, aspergillosis, or endemic mycoses, and/or documented positivity for human immunodeficiency virus (HIV) infection.
* 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 treated with no evidence of recurrence in the past 3 months, carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed)
* 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):
* 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 abnormalities with known effect on renal function; calculated eGFR \<60 mL/min (\<0.835 mL/s) using the CKD-EPI formula for adults
* 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 investigational drug and benznidazole
* 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

Contacts and Locations

Study Contact

Novartis Pharmaceuticals

CONTACT

1-888-669-6682

novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

+41613241111

Study Locations (Sites)

Olive View UCLA Educ and Res Ins

Sylmar, California, 91342

United States

University of Florida Shands

Gainesville, Florida, 32610-0486

United States

Boston Medical Center

Boston, Massachusetts, 02118

United States

Baylor College of Medicine

Houston, Texas, 77030-3411

United States

Collaborators and Investigators

Sponsor: Novartis Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-28

Study Completion Date2030-09-21

Study Record Updates

Study Start Date2025-04-28

Study Completion Date2030-09-21

Terms related to this study

Keywords Provided by Researchers

LXE408
Chronic Chagas disease
Chronic indeterminate Chagas disease
Chronic Chagas disease without severe organ dysfunction
CICD
Chronic CD
Trypanosoma cruzi

Additional Relevant MeSH Terms

Chagas Disease