A Phase II, Multicentre, Randomized, Two-arm Blinded Study to Assess

Clinical Trial Description

This study is run by DNDi with Novartis as co-development partner ;

Study Design

See also
	Status	Clinical Trial	Phase
	Completed	`NCT01067443` - Clinical Trial to Assess the Safety and Efficacy of Sodium Stibogluconate (SSG) and AmBisome® Combination, Miltefosine and AmBisome® and Miltefosine Alone for the Treatment Visceral Leishmaniasis in Eastern Africa	Phase 2
	Recruiting	`NCT05957978` - LXE408 for Treatment of Visceral Leishmaniasis in Ethiopia, a Proof of Concept Study	Phase 2

See also

Status

Clinical Trial

Phase

Completed

NCT01067443 - Clinical Trial to Assess the Safety and Efficacy of Sodium Stibogluconate (SSG) and AmBisome® Combination, Miltefosine and AmBisome® and Miltefosine Alone for the Treatment Visceral Leishmaniasis in Eastern Africa

Phase 2

Recruiting

NCT05957978 - LXE408 for Treatment of Visceral Leishmaniasis in Ethiopia, a Proof of Concept Study

Phase 2

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT05593666
Study type	Interventional
Source	Drugs for Neglected Diseases
Contact	Gwen Carn
Phone	+41 79 799 3886
Email	gcarn@dndi.org
Status	Recruiting
Phase	Phase 2
Start date	December 27, 2022
Completion date	January 2, 2025

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms