deltatrials
Completed PHASE3 INTERVENTIONAL 3-arm NCT03129646

Miltefosine/Paromomycin Phase III Trial for Treatment of Primary Visceral Leishmaniasis (VL) Patients in Eastern Africa

An Open Label, Phase III, Randomized Controlled, Multicentre Non-Inferiority Trial to Compare Efficacy and Safety of Miltefosine and Paromomycin With SSG and PM Combination for Treatment of Primary Visceral Leishmaniasis (VL) Patients in Eastern Africa

Sponsor: Drugs for Neglected Diseases

Updated 11 times since 2017 Last updated: Feb 27, 2024 Started: Jan 24, 2018 Primary completion: Dec 11, 2020 Completion: Dec 11, 2020
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on Visceral Leishmaniasis, this trial is completed. The trial is conducted by Drugs for Neglected Diseases and has accumulated 11 data snapshots since 2018. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~Jun 2017 – ~Mar 2018 · 9 months · monthly snapshotNot Yet Recruiting~Mar 2018 – ~Jun 2018 · 3 months · monthly snapshotRecruiting~Jun 2018 – ~Feb 2019 · 8 months · monthly snapshotRecruiting~Feb 2019 – ~Aug 2020 · 18 months · monthly snapshotRecruiting~Aug 2020 – ~Jan 2021 · 5 months · monthly snapshotActive Not Recruiting~Jan 2021 – ~Sep 2021 · 8 months · monthly snapshotActive Not Recruiting~Sep 2021 – ~Mar 2024 · 30 months · monthly snapshotCompleted~Mar 2024 – ~Jul 2024 · 4 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 10 months · monthly snapshotCompleted

Change History

11 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. Mar 2024 — Jul 2024 [monthly]

    Completed PHASE3

  5. Sep 2021 — Mar 2024 [monthly]

    Completed PHASE3

    Status: Active Not RecruitingCompleted

Show 6 earlier versions
  1. Jan 2021 — Sep 2021 [monthly]

    Active Not Recruiting PHASE3

  2. Aug 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE3

    Status: RecruitingActive Not Recruiting

  3. Feb 2019 — Aug 2020 [monthly]

    Recruiting PHASE3

  4. Jun 2018 — Feb 2019 [monthly]

    Recruiting PHASE3

  5. Mar 2018 — Jun 2018 [monthly]

    Recruiting PHASE3

    Status: Not Yet RecruitingRecruiting

  6. Jun 2017 — Mar 2018 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Drugs for Neglected Diseases
  • Kenya Medical Research Institute
  • Makerere University
  • The Institute of Endemic Diseases (IEND), University of Khartoum
  • The Netherlands Cancer Institute
  • University of Gondar
Data source: Drugs for Neglected Diseases

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