deltatrials
Completed PHASE3 INTERVENTIONAL 4-arm NCT01122771

Phase III, Study of Three Short Course Combo (Ambisome®, Miltefosine, Paromomycin) Compared With AmBisome for the Treatment of VL in Bangladesh

A Phase III, Open Label, Randomised, Study of Three Short Course Combination Regimens (Ambisome®, Miltefosine, Paromomycin) Compared With AmBisome® Alone for the Treatment of Visceral Leishmaniasis (VL) in Bangladesh

Sponsor: Drugs for Neglected Diseases

Conditions Visceral Leishmaniasis
Interventions Liposomal amphotericin B Miltefosine + Paromomycin liposomal amphotericin B + miltefosine liposomal amphotericin B + paromomycin
Updated 6 times since 2017 Last updated: Jan 20, 2016 Started: May 31, 2010 Primary completion: Mar 31, 2014 Completion: Mar 31, 2014
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Visceral Leishmaniasis and is currently completed. Drugs for Neglected Diseases leads this study, which shows 6 recorded versions since 2010 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 9 months · monthly snapshotCompleted

Change History

6 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE3

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  4. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE3

  5. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE3

▶ Show 1 earlier version

  1. Jan 2017 — Jun 2018 [monthly]

    Completed PHASE3

    First recorded

May 2010

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Drugs for Neglected Diseases
  • International Centre for Diarrhoeal Disease Research, Bangladesh
  • Shaheed Surhawardy Medical College and Hospital
Data source: Drugs for Neglected Diseases

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations