Trials / Active Not Recruiting
Active Not RecruitingNCT05593666
A Phase II, Multicentre, Randomized, Two-arm Blinded Study to Assess the Efficacy and Safety of Two LXE408 Regimens for Treatment of Patients With Primary Visceral Leishmaniasis
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 101 (actual)
- Sponsor
- Drugs for Neglected Diseases · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a phase II, multicentre, randomized, two-arm blinded study with an open label calibrator arm in adults and adolescents (≥12 years) with confirmed primary VL.
Detailed description
This study is run by DNDi with Novartis as co-development partner
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | LXE408 | Film-coated tablets |
| OTHER | Placebo | Placebo film-coated tablets |
| DRUG | AmBisome® | Sterile lyophilised powder in a 15 mL sterile clear glass vial |
Timeline
- Start date
- 2022-12-27
- Primary completion
- 2025-04-15
- Completion
- 2025-12-30
- First posted
- 2022-10-25
- Last updated
- 2025-12-18
Locations
2 sites across 1 country: India
Source: ClinicalTrials.gov record NCT05593666. Inclusion in this directory is not an endorsement.