6 completed, 3 terminated. 9 Phase 2, 1 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 9 | Completed 6, Terminated 3 |
| Phase 1 | 1 | Terminated 1 |
Follow Leishmaniasis, Visceral: new trials by email Literature Review of Leishmaniasis, Visceral trials Research Report on Leishmaniasis, Visceral
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Pharmacokinetics/Safety of Miltefosine Allometric Dose for the Treatment of Visceral Leishmaniasis in Children in Eastern Africa Miltefosine - Visceral Leishmaniasis | Phase 2 | Completed | Drugs for Neglected Diseases | 30 | 2015-05-01 | 2016-10-11 |
| Trial to Determine Efficacy of Fexinidazole in Visceral Leihmaniasis Patients in Sudan Fexinidazole - Visceral Leishmaniasis | Phase 2 | Terminated | Drugs for Neglected Diseases | 14 | 2013-11-01 | 2015-10-30 |
| 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 Liposomal amphotericin B (AmBisome®) and sodium stibogluconate, Liposomal amphotericin B + miltefosine, Miltefosine - Primary Visceral Leishmaniasis | Phase 2 | Completed | Drugs for Neglected Diseases | 151 | 2010-03-01 | 2017-04-24 |
| Open-Label, Sequential Step, Safety and Efficacy Study to Determine the Optimal Single Dose of Ambisome for Patients With VL Liposomal amphotericin B (Ambisome) - Visceral Leishmaniasis | Phase 2 | Terminated | Drugs for Neglected Diseases | 124 | 2009-04-01 | 2016-01-21 |
| Short Course of Miltefosine and Liposomal Amphotericin B for Kala-azar Liposomal amphotericin B and Miltefosine - Visceral Leishmaniasis | Phase 2 | Completed | Banaras Hindu University | 150 | 2007-10-01 | 2011-06-22 |
| A Phase II Study To Assess Safety and Efficacy Of Short-Course Regimens Of Amphotericin B Emulsion In Kala-Azar Amphotericin B fat emulsion in visceral leishmaniasis, Amphotericin B fat emulsion, Amphotericin B in fat emulsion - Visceral Leishmaniasis | Phase 2 | Completed | Banaras Hindu University | 60 | 2007-02-01 | 2008-09-12 |
| Combination Chemotherapy for the Treatment of Indian Kala-Azar Combination therapy with AmBisome and miltefosine - Visceral Leishmaniasis | Phase 2 | Completed | Banaras Hindu University | 200 | 2006-09-01 | 2008-09-12 |
| A Study Evaluating Sitamaquine Compared With Amphotericin B In The Treatment Of Visceral Leishmaniasis. sitamaquine - Leishmaniasis, Visceral | Phase 2 | Completed | GlaxoSmithKline | 61 | 2006-08-04 | 2017-09-18 |
| Miltefosine for Brazilian Visceral Leishmaniasis Miltefosine: initially 2.5 mg/kg/day for 28 days - Kala Azar | Phase 1 / Phase 2 | Terminated | AB Foundation | 80 | 2005-04-01 | 2016-07-12 |
Euglenozoa Infections (9) · Infections (9) · Leishmaniasis (9) · Parasitic Diseases (9) · Protozoan Infections (9) · Vector Borne Diseases (9)
liposomal amphotericin B (4) · miltefosine (4) · 8-aminoquinoline (1) · Amphotericin B (1) · Antimony Sodium Gluconate (1) · Combined Modality Therapy (1) · fexinidazole (1) · soybean oil, phospholipid emulsion (1)
Drugs for Neglected Diseases (4) · Banaras Hindu University (3) · AB Foundation (1) · GlaxoSmithKline (1)
India (4) · Sudan (3) · Kenya (2) · Brazil (1) · Ethiopia (1) · Uganda (1)
Shyam Sundar, MD (2) · Ahmed M Musa, MD PhD (1) · Dr. Rashid Juma, MD (1) · E. AG Khalil, Prof. MD (1) · Monique Wasunna, MD (1) · Prabhat K Sinha, MD (1) · Reynaldo Dietze (1) · Shyam Sundar (1) · Sisay Yifru, MD (1)
PMID 18781879, PMID 21129762, PMID 21375777, PMID 21633025, PMID 21718522, PMID 24454970, PMID 26573827, PMID 27627654, PMID 30188978