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

Conditions

• Chagas Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - 60 Years

Healthy Volunteers

Not accepted

Interventions

• 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)

Study Details

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.

Key Dates

Start date

Apr 28, 2025

Status verified

May 2026

Primary completion

Mar 22, 2027

Completion

Sep 21, 2030

Study Design

Enrollment

130 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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
• Placebo Comparator: Placebo 28 days
  Placebo administered by oral route
• Active Comparator: Benznidazole 60 days
  Benznidazole administered by oral route

Primary Outcome Measure

Presence or absence of sustained parasitological clearance using polymerase chain reaction (PCR) results over 6 months - LXE408 28 days versus placebo. [ Time Frame: At Months 2, 4, and 6 ]

Central Contacts

• Novartis Pharmaceuticals
  1-888-669-6682
  [email protected]
• Novartis Pharmaceuticals
  +41613241111

Locations (4)

Find similar trials in Sylmar, CA

Related Studies

• An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About the Risk of Pregnancy Complications and About the Mother's and Baby's Health
  Not Yet Recruiting · Bayer · Multiple Locations, West Virginia