A Phase 4 interventional study of AmBisome in Post-kala-azar Dermal Leishmaniasis, sponsored by Medecins Sans Frontieres, Netherlands. Completed. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2017-10-17.
Sponsored by Medecins Sans Frontieres, Netherlands · Phase 4, Interventional, and Treatment
Among 11 studies testing liposomal amphotericin B in Leishmaniasis, Visceral — none open to participants now, none under way, none of them phase 3. liposomal amphotericin B · Leishmaniasis, Visceral.
Among the 11 studies testing liposomal amphotericin B in Leishmaniasis, Visceral, this one is the 7th largest by enrollment, is one of 3 that started in 2014, is one of 3 in phase 4, and was the 10th registered.
68 studies on the registry are indexed under Leishmaniasis, Visceral; 7 are open to participants now.
Browse Leishmaniasis, Visceral studies →None of the 11 studies testing liposomal amphotericin B in Leishmaniasis, Visceral is open now. The open studies under Leishmaniasis, Visceral, anywhere →
liposomal amphotericin B: first FDA approval 1997 (AMBISOME). What it is approved for, and how studies give it, is on its page →
Of the 7 Leishmaniasis, Visceral studies recruiting now, 2 set no upper age limit and 3 stop at 75 or younger; 4 take children under 18; 1 takes healthy volunteers.
This study: 12 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
11 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 3 started in 2014.
This study's enrollment of 280 is above the median of 132 across 48 interventional studies indexed under Leishmaniasis, Visceral.
Median enrollment 378 across the 11 interventional studies. Of the 9 that completed or were terminated, 0 (0%) have results posted.
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None of the 11 has an industry lead sponsor. The 4 most frequent:
Medecins Sans Frontieres, Netherlands is the lead sponsor of 15 studies on the registry; 1 is open to participants now.
Medecins Sans Frontieres, Netherlands has 1 study filed under Leishmaniasis, Visceral — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 11 studies testing liposomal amphotericin B in Leishmaniasis, Visceral, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The safety and effectiveness of AmBisome 15 mg/kg, given over 15 days in 5 biweekly infusions of 3 mg/kg on an outpatient basis, is evaluated in clinically diagnosed PKDL patients of 12 years and older in a highly endemic area in Bangladesh. This is a prospective study, with the objective to assess final cure 12 months after treatment.
The safety and effectiveness of AmBisome 15 mg/kg, given over 15 days in 5 biweekly infusions of 3 mg/kg on an outpatient basis, was evaluated in clinically diagnosed PKDL patients of 12 years and older in a highly endemic area in Bangladesh. This was a prospective study, with the objective to assess final cure 12 months after treatment. Clinical response was monitored at 1, 3, 6, and 12 months after treatment, and safety during and up until one month after treatment. A total of 280 patients recruited between 8 April and 25 November 2014 received AmBisome. Of these, 272 were assessed at 12 months.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
-Patients of 12 years and older with probable PKDL (skin lesions strongly suggestive of PKDL with exclusion of other skin diseases, a history of VL treatment and a positive serological rK39 test)
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
280 patients, receiving AmBisome
Drug: AmBisome
A total dose of 15 mg/kg AmBisome given in doses of 3 mg/kg in a biweekly dosing schedule
Final outcome
The final outcome at 12 months was scored after carefully visual evaluation of the progress of all lesions of each patient compared to baseline.
Time frame: 12 months
Safety
Adverse events and serious adverse events were recorded during and up to one month after treatment.
Time frame: 7 weeks
Hypokalaemia
Assessment of hypokalaemia was based on serum potassium, measured in blood samples taken at different times during and after treatment.
Time frame: 7 weeks
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Apr 2014 to primary completion in Oct 2015, 18 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Liposomal amphotericin B
Medecins Sans Frontieres, Netherlands