Clinical trials: Leishmaniasis
Mucosal Leishmaniasis, Cutaneous Leishmaniasis
Miltefosine to Treat Mucocutaneous Leishmaniasis
The purpose of this Treatment Investigational New Drug application was to make miltefosine available for mucocutaneous leishmaniasis patients presenting in the United States.
- Trial name
- NCT01050907
- Testing
- Miltefosine
- Where
- 2 sites in United States
- Volunteers
- 4 people
- Sponsor
- Knight Therapeutics (USA) Inc
Visceral Leishmaniasis, Chagas Disease
A First-in-human, Safety, Tolerability, and Pharmacokinetics Study of LXE408 in Healthy Subjects
The purpose of this first-in-human study is to generate the necessary safety, tolerability, and pharmacokinetics (PK) information that will support further clinical development of LXE408 for the treatment of patients with…
- Trial name
- NCT07809919
- Testing
- LXE408, Iohexol
- Where
- United States
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Leishmaniasis, Visceral
To Study the Effect Of Single Infusions Of Amphotericin B Lipid Preparations in Treatment of Patients Of Kala Azar
The purpose of this study is to determine whether a single bolus of dose of Amphoterin B lipid emulsion (Amphomul) is as efficacious and safe compared to a single dose Liposomal Amphotericin B in treating patients with Indian…
- Trial name
- NCT00876824
- Testing
- Amphotericin B Lipid emulsion, Liposomal Amphotericin B
- Where
- 4 sites in India
- Volunteers
- 500 people
- Sponsor
- Bharat Serums and Vaccines Limited
Leishmaniasis
Safety, Tolerability and Pharmacokinetics (PKs) Investigation of GSK3186899 in Healthy Subjects
The purpose of this study is to evaluate the safety, tolerability and PK profile of single and repeat ascending doses of GSK3186899 in healthy subjects.
- Trial name
- NCT03874234
- Testing
- GSK3186899
- Where
- United Kingdom
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Leishmaniasis or Other Uses of Miltefosine
Treatment of Leishmaniasis With Impavido® (Miltefosine): Pregnancy Registry
The purpose of this observational study is to fulfill FDA Post Marketing Requirement (PMR) 2127-1 for miltefosine (NDA204684): implement a pregnancy registry for the time period Mar 2015-Mar 2024.
- Trial name
- NCT02427308
- Testing
- Miltefosine
- Where
- United States
- Sponsor
- Knight Therapeutics (USA) Inc
Visceral Leishmaniasis
Steady State Global Bioequivalence Study of Amphotericin B Liposome for Injection 50 mg/ Vial in Fed Condition
The primary objective is to determine clinical bioequivalence of Amphotericin B liposome for injection of Auromedics Pharma LLC, USA and AmBisome (Amphotericin B) liposome for injection of Astellas Pharma US, Inc., in patients…
- Trial name
- NCT03636659
- Testing
- Amphotericin B Liposome, AmBisome (Amphotericin B) Liposome
- Where
- 3 sites in Bangladesh, India
- Volunteers
- 140 people
- Sponsor
- Aurobindo Pharma Ltd
Leishmaniasis; American, Cutaneous, Drug Side Effect
Phase 2 Trial to Evaluate 18-Methoxycoronaridine Efficacy, Safety and Tolerability in Cutaneous Leishmaniasis Patients
It is a randomized phase II clinical study, unicentre aimed to evaluate the tolerability, safety and efficacy of 18-Methoxyoronaridine as a candidate of tegumentary leishmaniasis treatment.
- Trial name
- NCT03084952
- Testing
- 18-Methoxycoronaridine, Glucantime
- Volunteers
- 52 people
- Sponsor
- Infan Industria Quimica Farmaceutica Nacional
Leishmaniasis
Treatment of Leishmaniasis With Impavido® (Miltefosine): Higher-Weight Patient Registry
This study is a prospective observational study in which patients undergoing treatment for leishmaniasis with miltefosine (Impavido) in the US and who weigh > 75 kg can volunteer to provide information about their clinical…
- Trial name
- NCT02429505
- Testing
- Miltefosine
- Where
- United States
- Sponsor
- Knight Therapeutics (USA) Inc
Cutaneous Leishmaniasis
Safety, False-Positive Reactions and Sensitizing Properties of Leishmania Tropica Skin Test Antigen
The efficacy of LtSTA as a skin test antigen depends upon the sensitivity and specificity of the product. This study has been designed to measure the skin test responses to 15, 30, or 50µg doses of LtSTA.
- Trial name
- NCT00633009
- Testing
- Leishmania tropica Skin Test Antigen (LtSTA)
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Nielsen BioSciences, Inc.
Invasive Fungal Infections, Neutropenic Fever
Human Bioequivalence Study of Liposomal Amphotericin B for Injection
A single-center, randomized, open-label, single-dose, two-period, double-crossover study to evaluate the bioequivalence of liposomal amphotericin B for injection (test product) manufactured by Sichuan Huiyu Pharmaceutical Co.…
- Conditions
- Invasive Fungal Infections, Neutropenic Fever, Visceral Leishmaniasis
- Trial name
- NCT06983665
- Testing
- Test product (Liposomal amphotericin B for injection, Sichuan Huiyu Pharmaceutical Co., Ltd.), Reference product (AmBisome®, Astellas Pharma US Inc.)
- Where
- China
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Sichuan Huiyu Pharmaceutical Co., Ltd
Leishmaniasis
Safety, Tolerability and Pharmacokinetics (PK) Investigation of GSK3494245 in Healthy Participants
This study is the first to test GSK3494245 in humans, to evaluate its safety, tolerability, and pharmacokinetics (PK) after a single dose.
- Trial name
- NCT04504435
- Testing
- GSK3494245
- Where
- United Kingdom
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Mucocutaneous Leishmaniasis
Dedicated QT Study in Bolivian Patients Taking Impavido® (Miltefosine) for Mucocutaneous Leishmaniasis
This study is a Phase 4, open-label, single group study in which at least 40 adult patients undergoing miltefosine treatment for mucocutaneous leishmaniasis (CL and ML) will be assessed by 12-lead ECG for prolongation of the…
- Trial name
- NCT02429518
- Testing
- Miltefosine
- Where
- Bolivia
- Volunteers
- 42 people
- Sponsor
- Knight Therapeutics (USA) Inc
Mucocutaneous Leishmaniasis
Spermiogram Assessment in Bolivian Patients Taking Impavido® (Miltefosine) for Mucocutaneous Leishmaniasis
This study is a Phase 4, open-label, single group study in which at least 55 evaluable adult male patients undergoing miltefosine treatment for mucocutaneous leishmaniasis will provide semen samples for spermiogram analysis of…
- Trial name
- NCT02431429
- Testing
- Miltefosine
- Where
- Bolivia
- Volunteers
- 55 people
- Sponsor
- Knight Therapeutics (USA) Inc
Leishmaniasis, Visceral
A Study Evaluating Sitamaquine Compared With Amphotericin B In The Treatment Of Visceral Leishmaniasis.
Sitamaquine is an 8-aminoquinoline which is being developed as an oral treatment for visceral leishmaniasis (VL). Pre-clinical and subsequent clinical investigations have demonstrated oral efficacy against Leishmania donovani.
- Trial name
- NCT00381394
- Testing
- sitamaquine
- Where
- 3 sites in India
- Volunteers
- 61 people
- Sponsor
- GlaxoSmithKline
Invasive Fungal Infections, Neutropenic Fever
Human Bioequivalence Study of Amphotericin B Liposome for Injection
Single-center, randomized, open-label, single-dose, two-treatment, two-period, two-sequence crossover design to evaluate the human bioequivalence of two Amphotericin B Liposome for Injection formulations
- Conditions
- Invasive Fungal Infections, Neutropenic Fever, Visceral Leishmaniasis
- Trial name
- NCT06977490
- Testing
- Amphotericin B Liposome for Injection (strength: 50 mg, Sichuan Huiyu Pharmaceutical Co., Ltd.), Amphotericin B Liposome for Injection (trade name: Ambisome®, strength: 50 mg, MAH: Gilead Sciences)
- Where
- China
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Sichuan Huiyu Pharmaceutical Co., Ltd