A Study of Efficacy, Safety, Tolerability of LXE408 in Participants With Chronic Chagas Disease.
Chagas Disease
De qué trata este estudio
El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.
- Tipo de estudio
- De intervención
- Fase
- Fase 2
- Rango de edad
- 18 años - 60 años
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 130 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
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.
Leer la descripción completa
This is an interventional, phase 2, PoC (Proof of Concept) randomized, participant- and investigator-blinded, controlled, parallel group study, with 4 treatment arms. The purpose of this study is to assess the efficacy (anti-parasitological activity), safety, PK (pharmacokinetics), and PD (pharmacodynamics) of LXE408 in participants with CICD (chronic indeterminate Chagas disease) and chronic Chagas disease without severe cardiac or gastrointestinal dysfunction compared to placebo and to benznidazole.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
Inclusion 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
Exclusion Criteria:
- 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):
Any single parameter of ALT, AST, alkaline phosphatase must not exceed 1.5x ULN at screening Serum bilirubin must not exceed the ULN at screening elevated serum bilirubin is not excluded if there is a documented history of Gilbert's Syndrome
- 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
Other protocol-defined inclusion/exclusion criteria may apply.
Entiende la evaluación inicialTratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- Asignación al azar
- Enmascaramiento
- Enmascaramiento cuádruple
LXE408 28 days
LXE408 administered by oral route
LXE408 14 days and Placebo 14 days
LXE408 administered by oral route, followed by Placebo administered by oral route
Drug: LXE408 · Drug: Placebo
Placebo 28 days
Placebo administered by oral route
Drug: Placebo
Benznidazole 60 days
Benznidazole administered by oral route
Drug: Benznidazole
LXE408 DRUG
LXE408 administered by oral route
Placebo DRUG
Placebo administered by oral route
Benznidazole DRUG
Benznidazole administered by oral route (administered as standard of care)
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Presence or absence of sustained parasitological clearance using polymerase chain reaction (PCR) results over 6 months - LXE408 28 days versus placebo.
Plazo: At Months 2, 4, and 6
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.
Medidas secundarias
Presence or absence of sustained parasitological clearance using polymerase chain reaction (PCR) results over 6 months - LXE408 -14 days versus placebo
Plazo: At Months 2, 4, and 6
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.
Presence or absence of sustained parasitological clearance using polymerase chain reaction (PCR) results over 6 months-LXE408 - 28 days and 14 days versus benznidazone
Plazo: At Months 2, 4, and 6
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.
Presence or absence of early parasitological clearance
Plazo: At Day 7, 14 and 28
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.
Presence or absence of sustained parasitological clearance over 12 months by PCR testing
Plazo: 12 Months
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 to parasitological clearance based on serial PCR testing
Plazo: 12 Months
Time to parasitological clearance based on PCR by treatment will be estimated using the Kaplan-Meier approach.
Presence or absence of seroreversion using conventional serology
Plazo: At Month 6 and Month 12
Seroreversion as measured by conventional serology will be evaluated at 6 and 12-month study visits. Seroreversion is determined by the proportion of participants achieving serology changes from positive at baseline to negative at each time point.
Occurrence and severity of treatment emergent adverse events during the study
Plazo: Up to 12 Months
Incidence and severity of AEs by treatment group, including changes in the vital signs, electrocardiogram and laboratory results qualifying and reported as AEs.
Occurrence of adverse events resulting in treatment discontinuation
Plazo: Up to 12 Months
Incidence of AEs that result in treatment discontinuation.
Occurrence of all-cause mortality through end of study visit
Plazo: Up to 48 Months
Incidence of death through the end of study visit.
Maximum plasma concentration (Cmax) of LXE408
Plazo: At Day 1, 7, 14, 28
Cmax is defined as the maximum (peak) observed concentration following a dose.
Time to maximum plasma concentration (Tmax) of LXE408
Plazo: At Day 1, 7, 14, 28
Tmax is defined as the time to reach maximum (peak) concentration following a dose.
Area under the plasma concentration-time curve from time 0 to 8 hours post-dose (AUC0-8)
Plazo: At Day 1, 7, 14, 28
AUC0-8 will be calculated by non-compartmental methods based on LXE408 plasma concentration data.
Pre-dose concentration
Plazo: At Day 14 and Day 28
Pre-dose concentration is the observed plasma concentration that is just prior to the beginning of, or at the end of a dosing interval.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (22)
El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.
22 centros
Olive View UCLA Educ and Res InsSylmar, California, United StatesReclutando
University of Florida ShandsGainesville, Florida, United StatesReclutando
Boston Medical CenterBoston, Massachusetts, United StatesReclutando
Baylor College of MedicineHouston, Texas, United StatesReclutando
Novartis Investigative SiteCABA, Buenos Aires, ArgentinaReclutando
Novartis Investigative SiteCABA, Buenos Aires, ArgentinaReclutando
Novartis Investigative SiteCórdoba, Córdoba Province, ArgentinaReclutando
Novartis Investigative SiteCaba, ArgentinaReclutando
Novartis Investigative SiteCorrientes, ArgentinaReclutando
Novartis Investigative SiteFormosa, ArgentinaReclutando
Novartis Investigative SiteMontes Claros, Minas Gerais, BrazilReclutando
Novartis Investigative SiteRecife, Pernambuco, BrazilReclutando
Novartis Investigative SiteRio de Janeiro, Rio de Janeiro, BrazilReclutando
Novartis Investigative SitePorto Alegre, Rio Grande do Sul, BrazilReclutando
Novartis Investigative SiteSão Caetano do Sul, São Paulo, BrazilReclutando
Novartis Investigative SiteSão Paulo, São Paulo, BrazilReclutando
Novartis Investigative SiteBarranquilla, Atlántico, ColombiaReclutando
Novartis Investigative SiteYopal, Casanare Department, ColombiaActivo, sin reclutamiento
Novartis Investigative SiteBogotá, ColombiaReclutando
Novartis Investigative SiteBogotá, ColombiaReclutando
Novartis Investigative SiteFloridablanca, ColombiaReclutando
Novartis Investigative SiteSan Gil, ColombiaReclutando
Equipo y fechas
- Patrocinador principal
- Novartis Pharmaceuticals
- Inicio del estudio
- 28 abr 2025 Real
- Finalización primaria
- 22 jul 2027 Estimado
- Finalización del estudio
- 21 ene 2031 Estimado
- Primera publicación
- 9 oct 2024 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
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.
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026