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A Prospective, Multicentric, Randomized, Two Arm, Open Label Phase III Study To Assess Efficacy And Safety Of Infusion Of Amphomul® (Amphotericin B Emulsion) As Compared To Liposomal Amphotericin In Patients Of Visceral Leishmaniasis (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 Visceral Leishmaniasis (Kala Azar).
Details
| Lead sponsor | Bharat Serums and Vaccines Limited |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 500 |
| Start date | 2009-07 |
| Completion | 2011-01 |
Conditions
- Leishmaniasis, Visceral
Interventions
- Amphotericin B Lipid emulsion
- Liposomal Amphotericin B
Primary outcomes
- Clinical and parasitological cure at end of treatment and final cure (no relapse) at six months — Six months after dose administration
Countries
India