Clinical trials: Primary Visceral Leishmaniasis
Primary Visceral Leishmaniasis
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
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.
- Trial name
- NCT05593666
- Testing
- LXE408, AmBisome®
- Where
- 2 sites in India
- Volunteers
- 101 people
- Sponsor
- Drugs for Neglected Diseases
Visceral Leishmaniasis
Miltefosine/Paromomycin Phase III Trial for Treatment of Primary Visceral Leishmaniasis (VL) Patients in Eastern Africa
This is an open label, Phase III, randomized, controlled, parallel arm multicentre non-inferiority clinical trial to compare the efficacy and safety of two combination regimens of Miltefosine and Paromomycin with the standard…
- Trial name
- NCT03129646
- Testing
- Miltefosine, Paromomycin, Sodium stibogluconate
- Where
- 7 sites in Ethiopia, Kenya and 2 more
- Volunteers
- 439 people
- Sponsor
- Drugs for Neglected Diseases
Primary Visceral Leishmaniasis
LXE408 for Treatment of Visceral Leishmaniasis in Ethiopia, a Proof of Concept Study
This is a randomized, open-label, phase II, single-centre study, with one LXE408 regimen and one calibrator arm with the standard of care SSG combined with PM, to be conducted in male and female adult (≥18 years and <45 years)…
- Trial name
- NCT05957978
- Testing
- LXE408, sodium stibogluconate, Paromomycin
- Where
- Ethiopia
- Volunteers
- 52 people
- Sponsor
- Drugs for Neglected Diseases
Visceral Leishmaniasis
Pharmacokinetics/Safety of Miltefosine Allometric Dose for the Treatment of Visceral Leishmaniasis in Children in Eastern Africa
This is a multicenter, non-comparative, open-label clinical trial to assess the Pharmacokinetics (PK) and safety of miltefosine using an allometric dose algorithm in the treatment of children with primary Visceral Leishmaniasis…
- Trial name
- NCT02431143
- Testing
- Miltefosine
- Where
- 2 sites in Kenya, Uganda
- Volunteers
- 30 people
- Sponsor
- Drugs for Neglected Diseases
Primary Visceral Leishmaniasis
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
This study is to assess if shorter combinations of SSG plus single dose AmBisome®, Miltefosine plus single dose AmBisome® and Miltefosine alone are effective in treating visceral leishmaniasis in Eastern Africa.
- Trial name
- NCT01067443
- Testing
- Liposomal amphotericin B (AmBisome®) and sodium stibogluconate, Liposomal amphotericin B + miltefosine, Miltefosine
- Where
- 3 sites in Kenya, Sudan
- Volunteers
- 151 people
- Sponsor
- Drugs for Neglected Diseases
Leishmaniasis, Leishmaniasis, Visceral
Incidence of Relapse and Post-Kala-Azar Dermal Leishmaniasis in South Sudan
This study aims to describe the burden of Post-Kala-Azar Dermal Leishmaniasis and visceral leishmaniasis relapse in a cohort of patients discharged after successful treatment of primary visceral leishmaniasis.
- Conditions
- Leishmaniasis, Leishmaniasis, Visceral, Post-kala-azar Dermal Leishmaniasis
- Trial name
- PKDL (NCT05449717)
- Where
- South Sudan
- Volunteers
- 52 people
- Sponsor
- Epicentre