KAMRC Trials

 
 
 
 
 
1
Arbindo Pharma (2018)
A Multi-Center, Open-Label, Randomized, Two treatment, Parallel, Single period, Multiple-Dose, Steady state, Global Bioequivalence study of Amphotericin B Liposome for Injection 50mg /vial (Test) of AuromedicsPharma LLC, USA and AmBisome® (Amphotericin B) Liposome for Injection 50mg/vial (Reference) of AstellasPharma US, inc. in patients with Visceral Leishmaniasis under fed (non-high fat breakfast) condition
 
2
Life care Innovation (2018) ONGOING
A phase III, Open Label, Randomized Trial of Three Single Dose Treatment Regimens of FungisomeTM (Either Alone or in Combination with Miltefosine) Compared with Single Dose Treatment Regimen of AmBisome®, For Visceral Leishmaniasis (VL) in India.
 
3
Cipla LTD (2017)
A multicenter, open label, randomized, two treatment, parallel design, steady state study to compare the bioavailability of the Test product [Amphotericin B (Liposome for injection) 50 mg/vial, Cipla Ltd., India] with Reference product [AmBisome® (Amphotericin B) Liposome for injection 50 mg/vial), Gilead life sciences, USA] in adult patients with visceral leishmaniasis.
 
4
Sun Pharma (2017)
A randomized, open label, two treatment, one period, multiple dose, steady-state, parallel, bioequivalence study of amphotericin b liposome for injection 50 mg / vial of sun pharmaceutical industries limited and ambisome (amphotericin b) liposome for injection 50 mg / vial of astellas pharma in 48 (24+24) patients under fed condition
 
5
Lifecare Innovation Pvt. Ltd. (2011)
A Prospective, Open-label, Non-comparative, Sequential, Phase II, Multi-center Study to Assess Safety of Single-Dose Regimen at Two Dose Levels of FUNGISOME™ in Treatment of Visceral Leishmaniasis (Kala-Azar)
 
6
SIRO (2009)
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 AmBisome in Patients of Visceral Leishmaniasis (Kala-azar)
 
7
DNDi (Drugs for Neglected Diseases Initiative)  (2008)
A randomised, open-label, parallel-group, safety and efficacy study to evaluate different combination treatment regimens (co-administration), of either AmBisome and paromomycin, AmBisome and Miltefosine, or Paromomycin and Miltefosine compared with Amphotericin B deoxycholate (the standard) therapy for the treatment of acute, symptomatic Visceral Leishmaniasis (VL) 
 
8
iOWH (2007)
A Phase 4 Study to Expand Access While Assessing the Safety and Efficacy of Paromomycin IM Injection in an Outpatient Setting for the Treatment of Visceral Leishmaniasis (VL) in India
 
VLPM03
9
GSK (2007)
A Phase II, multi centre,Open label,  randomised study to evaluate the safety, tolerability and pharmcokinetics of oral sitamaquine compared with Amphotericin B in the treatment of Visceral Leishniasis caused by L.donovani in endemic areas.
 
10
iOWH (2007)
a randomized, double-blind, multi-center, three-arm study intended to assess the safety and efficacy of three different doses/dose regimens of paromomycin administered intramuscularly as follows: 11 mg/kg/day for 14 days, 15 mg/kg/day for 14 days, and 11 mg/kg/day for 21 days for the treatment of visceral leishmaniasis (VL) in India.
 
VLPM-02
11
Bharat Serum (2007)
A prospective, single centre, open level, Dose escalation Phase II study to access and efficacy of short course regimens of Amphomul ( Amphotericin B Emulsion). In Treatment Naïve or Resistant cases of Visceral Leishmaniasis(Kala-Azar)
 
12
ICMR/WHO (2007)
Safety and efficacy of oral miltefosine in patients with post kala azar dermal leishmaniasis (PKDL) – dose-finding study comparing  8 and 12 weeks of treatment
 
PKDL Study D-18506- Z015  Phase I/II
13
ICMR/WHO (2007)
The efficacy and safety of a short course of Miltefosine and liposomal Amphotericin B for Visceral Leishmaniasis in India.
 
14
iOWH  (2003)
Multicentre, Randomized, Controlled, Clinical Trial to Assess the Safety and Efficacy of Injectable Paromomycin in Patients with Visceral Leishmaniasis
 
VLPM01
15
ICMR (2003)
ICMR-Phase IV Trial of Miltefosine in the Treatment of Visceral Leishmaniasis
 
ICMR-MILT PHASE IV
16
GSK 252220B(WR602) (2002)
Determination of oral Sitamaquine for efficacy, safety and tolerance in subjects with visceral leishmaniasis caused by L. donovani in India sponsored by GSK, India
 
252220/006