deltatrials
Terminated PHASE2 INTERVENTIONAL 4-arm NCT02497612

To Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of a Single Dose Regimen of Ferroquine and Artefenomel in Adults and Children With Uncomplicated Plasmodium Falciparum Malaria (FALCI)

A Randomized, Double-blind, Phase IIb Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of a Single Dose Regimen of Ferroquine (FQ) With Artefenomel (OZ439) in Adults and Children With Uncomplicated Plasmodium Falciparum Malaria

Sponsor: Medicines for Malaria Venture

Updated 22 times since 2017 Last updated: Mar 15, 2022 Started: Jul 25, 2015 Primary completion: Sep 23, 2019 Completion: Sep 23, 2019
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

All treatment arms met the futility criteria for efficacy during the pre-planned interim analysis, therefore the study was stopped.

A PHASE2 clinical study on Plasmodium Falciparum Infection, this trial is terminated or withdrawn. The trial is conducted by Medicines for Malaria Venture and has accumulated 22 data snapshots since 2015. Infectious disease trials contribute critical data for public health response and treatment development.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Jul 2017 · 5 months · monthly snapshot~Jul 2017 – ~Aug 2017 · 31 days · monthly snapshot~Aug 2017 – ~Sep 2017 · 31 days · monthly snapshot~Sep 2017 – ~Dec 2017 · 3 months · monthly snapshot~Dec 2017 – ~Feb 2018 · 2 months · monthly snapshot~Feb 2018 – ~Jun 2018 · 4 months · monthly snapshot~Jun 2018 – ~Aug 2018 · 2 months · monthly snapshot~Aug 2018 – ~Nov 2018 · 3 months · monthly snapshot~Nov 2018 – ~Jul 2019 · 8 months · monthly snapshot~Jul 2019 – ~Sep 2019 · 2 months · monthly snapshot~Sep 2019 – ~Oct 2019 · 30 days · monthly snapshot~Oct 2019 – ~Nov 2019 · 31 days · monthly snapshot~Nov 2019 – ~Dec 2019 · 30 days · monthly snapshot~Dec 2019 – ~Nov 2020 · 11 months · monthly snapshot~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshot~Jan 2021 – ~Dec 2021 · 11 months · monthly snapshot~Dec 2021 – ~Apr 2022 · 4 months · monthly snapshot~Apr 2022 – ~Jul 2024 · 27 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 10 months · monthly snapshot

Change History

22 versions recorded
  1. Sep 2025 — Present [monthly]

    Terminated PHASE2

  2. Sep 2024 — Sep 2025 [monthly]

    Terminated PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE2

  4. Apr 2022 — Jul 2024 [monthly]

    Terminated PHASE2

  5. Dec 2021 — Apr 2022 [monthly]

    Terminated PHASE2

Show 17 earlier versions
  1. Jan 2021 — Dec 2021 [monthly]

    Terminated PHASE2

  2. Nov 2020 — Jan 2021 [monthly]

    Terminated PHASE2

  3. Dec 2019 — Nov 2020 [monthly]

    Terminated PHASE2

    Status: RecruitingTerminated

  4. Nov 2019 — Dec 2019 [monthly]

    Recruiting PHASE2

  5. Oct 2019 — Nov 2019 [monthly]

    Recruiting PHASE2

  6. Sep 2019 — Oct 2019 [monthly]

    Recruiting PHASE2

  7. Jul 2019 — Sep 2019 [monthly]

    Recruiting PHASE2

  8. Nov 2018 — Jul 2019 [monthly]

    Recruiting PHASE2

  9. Aug 2018 — Nov 2018 [monthly]

    Recruiting PHASE2

  10. Jun 2018 — Aug 2018 [monthly]

    Recruiting PHASE2

  11. Feb 2018 — Jun 2018 [monthly]

    Recruiting PHASE2

  12. Dec 2017 — Feb 2018 [monthly]

    Recruiting PHASE2

  13. Sep 2017 — Dec 2017 [monthly]

    Recruiting PHASE2

  14. Aug 2017 — Sep 2017 [monthly]

    Recruiting PHASE2

  15. Jul 2017 — Aug 2017 [monthly]

    Recruiting PHASE2

  16. Feb 2017 — Jul 2017 [monthly]

    Recruiting PHASE2

  17. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE2

    First recorded

Jul 2015

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Medicines for Malaria Venture
  • Sanofi
Data source: Sanofi

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