Visceral Leishmaniasis
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CLINICAL_TRIALS trial_result · 2016-10-11Clinical Trial Update: Pharmacokinetics/Safety of Miltefosine Allometric Dose for the Treatment of Visceral Leishmaniasis in Children in Eastern Africa [Phase 2]
Phase 2 trial evaluated an allometric miltefosine dosing strategy for visceral leishmaniasis in children in Eastern Africa, focusing on phar…
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CLINICAL_TRIALS trial_result · 2016-07-12Clinical Trial Update: Miltefosine for Brazilian Visceral Leishmaniasis [Phase 1, Phase 2]
Miltefosine was studied in Phase 1 and Phase 2 trials for visceral leishmaniasis in Brazil (Kala Azar), but the study was terminated.
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CLINICAL_TRIALS trial_result · 2016-03-22Clinical Trial Update: Efficacy/Safety of Sodium Stibogluconate (SSG) Versus Paromomycin (PM) and SSG/PM Combination to Treat V Leishmaniasis [Phase 3]
Phase 3 trial comparing Sodium Stibogluconate, Paromomycin, and their combination for visceral leishmaniasis reports efficacy and safety dat…
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CLINICAL_TRIALS trial_result · 2016-02-23Clinical Trial Update: Phase 1 LEISH-F3 + SLA-SE Vaccine Trial in Healthy Adult Volunteers [Phase 1]
Phase 1 study of the LEISH-F3 + SLA-SE vaccine in healthy adults has completed, evaluating safety and immunogenicity related to visceral lei…
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CLINICAL_TRIALS trial_result · 2016-01-21Clinical Trial Update: Phase III, Study of Three Short Course Combo (Ambisome®, Miltefosine, Paromomycin) Compared With AmBisome for the Treatment of VL in Bangladesh [Phase 3]
A Phase III trial comparing a short-course combination therapy (Ambisome, Miltefosine, Paromomycin) to AmBisome for visceral leishmaniasis i…
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CLINICAL_TRIALS trial_result · 2016-01-21Clinical Trial Update: Open-Label, Sequential Step, Safety and Efficacy Study to Determine the Optimal Single Dose of Ambisome for Patients With VL [Phase 2]
The Phase 2 open-label safety and efficacy study to determine the optimal single-dose regimen of Ambisome for visceral leishmaniasis has bee…
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FDA approval · 2016-01-04FDA Approved: IMPAVIDO — Supplemental Application (Profounda, Inc.)
FDA approved a supplemental application for IMPAVIDO (miltefosine) from Profounda, Inc. under NDA204684, expanding its approved use. This ac…
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CLINICAL_TRIALS trial_result · 2015-10-30Clinical Trial Update: Trial to Determine Efficacy of Fexinidazole in Visceral Leihmaniasis Patients in Sudan [Phase 2]
This clinical trial update concerns a Phase 2 study evaluating fexinidazole for visceral leishmaniasis in Sudan. The study has been terminat…
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FDA approval · 2015-04-10FDA Approved: IMPAVIDO — Supplemental Application (Profounda, Inc.)
FDA approved a supplemental application for IMPAVIDO (miltefosine) filed by Profounda, Inc.
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CLINICAL_TRIALS trial_result · 2015-04-03Clinical Trial Update: Open-Label Safety Study of Three-Antigen Leishmania Polyprotein With Adjuvant MPL-SE in Healthy Adults in India [Phase 1]
Phase 1 open-label safety study of a three-antigen Leishmania polyprotein vaccine with MPL-SE adjuvant in healthy adults in India; the trial…
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CLINICAL_TRIALS trial_result · 2014-11-05Clinical Trial Update: A Study to Explore Association of Treatment Regimens for Visceral Leishmaniasis, Host Immunological, Genetical and Nutrition Factors With Post-kala-azar Dermal Leishmaniasis (PKDL) [Phase 4]
A Phase 4 clinical trial completed in Bangladesh evaluated how different treatment regimens for visceral leishmaniasis, along with host immu…
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CLINICAL_TRIALS trial_result · 2014-10-03Clinical Trial Update: Safety and Efficacy Study of Paromomycin to Treat Visceral Leishmaniasis [Phase 3]
Phase 3 clinical trial evaluating the safety and efficacy of paromomycin for visceral leishmaniasis has completed.
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CLINICAL_TRIALS trial_result · 2014-10-03Clinical Trial Update: Expand Access/Assess Safety and Efficacy of Paromomycin IM Injection for the Treatment of Visceral Leishmaniasis [Phase 4]
This Phase 4 update reports completion of a study evaluating the safety and efficacy of intramuscular paromomycin for visceral leishmaniasis…
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CLINICAL_TRIALS trial_result · 2014-05-28Clinical Trial Update: Visceral Leishmaniasis and Malnutrition in Amhara Regional State, Ethiopia
A completed clinical trial sponsored by Instituto de Salud Carlos III in Ethiopia examined visceral leishmaniasis in the context of malnutri…
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CLINICAL_TRIALS trial_result · 2014-04-04Clinical Trial Update: An Effectiveness Study of Paromomycin IM Injection (PMIM) for the Treatment of Visceral Leishmaniasis (VL) in Bangladesh [NA]
A completed clinical trial evaluating the effectiveness of paromomycin administered by intramuscular injection for visceral leishmaniasis in…
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FDA approval · 2014-03-19FDA Approved: IMPAVIDO — Original Application (Profounda, Inc.)
FDA approved IMPAVIDO (miltefosine) through Profounda, Inc. via Original Application (NDA204684) for visceral leishmaniasis and post-kala-az…
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CLINICAL_TRIALS trial_result · 2014-01-22Clinical Trial Update: Single Dose Liposomal Amphotericin B for Visceral Leishmaniasis [Phase 4]
Phase 4 clinical trial update evaluating a single-dose liposomal amphotericin B regimen for visceral leishmaniasis, sponsored by Banaras Hin…
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CLINICAL_TRIALS withdrawal · 2013-08-28Clinical Trial Update: SCH708980 With and Without AmBisome for Visceral Leishmaniasis [Phase 1, Phase 2]
The NIAID-sponsored Phase 1/2 trial of SCH708980 for visceral leishmaniasis, with and without AmBisome, has been withdrawn.
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CLINICAL_TRIALS trial_result · 2012-11-14Clinical Trial Update: A Community Trial for Visceral Leishmaniasis (VL) [NA]
A community trial for visceral leishmaniasis conducted by the International Centre for Diarrhoeal Disease Research, Bangladesh has completed…
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CLINICAL_TRIALS trial_result · 2011-06-22Clinical Trial Update: Short Course of Miltefosine and Liposomal Amphotericin B for Kala-azar [Phase 2]
This document reports the completion of a Phase 2 clinical trial evaluating a short course combination of miltefosine and liposomal amphoter…
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CLINICAL_TRIALS trial_result · 2011-06-02Clinical Trial Update: To Study the Effect Of Single Infusions Of Amphotericin B Lipid Preparations in Treatment of Patients Of Kala Azar [Phase 3]
A Phase 3 trial evaluating single infusions of amphotericin B lipid formulations for visceral leishmaniasis (Kala-azar) has completed.
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CLINICAL_TRIALS research · 2010-06-08Clinical Trial Update: Immune Response of Visceral Leishmaniasis PatientsTreated With Antimonial Plus N-Acetylcysteine [NA]
An update on a clinical trial assessing the immune response in visceral leishmaniasis patients treated with an antimonial drug plus N-acetyl…
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CLINICAL_TRIALS trial_result · 2010-05-26Clinical Trial Update: Combination Therapy in Indian Visceral Leishmaniasis [Phase 3]
A Phase 3 clinical trial in India evaluating a combination therapy for visceral leishmaniasis has completed. The study was conducted at Bana…
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CLINICAL_TRIALS trial_result · 2010-02-11Clinical Trial Update: Safety and Efficacy Study to Evaluate Different Combination Treatment Regimens for Visceral Leishmaniasis [Phase 3]
Completed Phase 3 clinical trial evaluating different combination regimens for visceral leishmaniasis, focusing on safety and efficacy.
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CLINICAL_TRIALS trial_result · 2009-11-04Clinical Trial Update: Efficacy, Acceptability and Cost-effectiveness of Long Lasting Insecticide Nets (LLIN) in the Prevention of Kala Azar [NA]
A completed clinical trial assessed the efficacy, acceptability, and cost-effectiveness of long-lasting insecticidal nets for preventing vis…