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.
Status: Recruiting
Location: See all (17) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This study is to investigate the ability of LXE408 to reduce or remove the level of parasites in the blood of people with chronic Chagas disease. Participants must have chronic Chagas disease without severe organ dysfunction.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:
• 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
Locations
United States
California
Olive View UCLA Educ and Res Ins
RECRUITING
Sylmar
Massachusetts
Boston Medical Center
RECRUITING
Boston
Texas
Baylor College of Medicine
RECRUITING
Houston
Other Locations
Argentina
Novartis Investigative Site
RECRUITING
Caba
Novartis Investigative Site
RECRUITING
Caba
Novartis Investigative Site
RECRUITING
Córdoba
Novartis Investigative Site
RECRUITING
Corrientes
Novartis Investigative Site
RECRUITING
Formosa
Brazil
Novartis Investigative Site
RECRUITING
Montes Claros
Novartis Investigative Site
RECRUITING
Rio De Janeiro
Novartis Investigative Site
RECRUITING
São Caetano Do Sul
Colombia
Novartis Investigative Site
RECRUITING
Barranquilla
Novartis Investigative Site
RECRUITING
Bogotá
Novartis Investigative Site
RECRUITING
Bogotá
Novartis Investigative Site
RECRUITING
Floridablanca
Novartis Investigative Site
RECRUITING
San Gil
Novartis Investigative Site
RECRUITING
Yopal
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
1-888-669-6682
Backup
Novartis Pharmaceuticals
+41613241111
Time Frame
Start Date:2025-04-28
Estimated Completion Date:2027-09-22
Participants
Target number of participants:130
Treatments
Experimental: LXE408 28 days
LXE408 administered by oral route
Experimental: LXE408 14 days and Placebo 14 days
LXE408 administered by oral route, followed by Placebo administered by oral route