10 completed, 2 withdrawn, 1 recruiting, 1 terminated. 5 Phase 1, 4 Phase 4, 3 Phase 2, 1 Not applicable, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 5 | Completed 5 |
| Phase 4 | 4 | Completed 3, Recruiting 1 |
| Phase 2 | 3 | Completed 1, Terminated 1, Withdrawn 1 |
| Not applicable | 1 | Withdrawn 1 |
| Phase 3 | 1 | Completed 1 |
Follow Lumefantrine: new trials by email Literature Review of Lumefantrine trials Research Report on Lumefantrine
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Southeast Asia Dose Optimization of Tafenoquine Tafenoquine, Chloroquine, Artemether 20 mg-Lumefantrine 120 mg - Plasmodium Vivax Malaria | Phase 4 | Recruiting | University of Oxford | 820 | 2024-07-22 | 2026-10-09 |
| Drug-drug Interaction Study of Ganaplacide and Lumefantrine With Efavirenz Ganaplacide, Lumefantrine, Efavirenz - Malaria | Phase 1 | Completed | Novartis Pharmaceuticals | 14 | 2022-04-28 | 2023-01-12 |
| Drug-drug Interaction Study of Ganaplacide and Lumefantrine With Midazolam, Repaglinide, Dextromethorphan, Metformin, Rosuvastatin and Dolutegravir Midazolam, Repaglinide, Dextromethorphan - Malaria | Phase 1 | Completed | Novartis Pharmaceuticals | 48 | 2022-03-09 | 2022-11-04 |
| To Evaluate Efficacy, Safety, Tolerability and PK of Intravenous Cipargamin in Participants With Severe Plasmodium Falciparum Malaria Cipargamin, IV Artesunate, Coartem - Severe Malaria | Phase 2 | Completed | Novartis Pharmaceuticals | 254 | 2022-03-07 | 2026-04-09 |
| Drug-drug Interaction Study of Ganaplacide and Lumefantrine With Itraconazole Ganaplacide, Lumefantrine, Itraconazole - Malaria | Phase 1 | Completed | Novartis Pharmaceuticals | 19 | 2021-11-18 | 2022-10-28 |
| A Clinical Trial to Evaluate Plasmodium Falciparum 7G8 and NF54 Challenge Strains (PfSPZ) in a Head-to-head Comparative Study - (ECG-CHMI) atovaquone-proguanil - Plasmodium Falciparum | Not applicable | Withdrawn | U.S. Army Medical Research and Development Command | 2020-03-01 | 2020-05-08 | |
| A Study to Assess the Safety and Efficacy of 5-aminolevulinic Acid Hydrochloride (5-ALA HCl) and Sodium Ferrous Citrate (SFC) Added on Artemisinin-based Combination Therapy (ACT) in Adult Patients With Uncomplicated Malaria 5-aminolevulinic acid hydrochloride (5-ALA HCl) 600 mg QD, Sodium ferrous citrate (SFC) 472 mg QD, Artemisinin-based combination (ACT) - Malaria | Phase 2 | Withdrawn | Neopharma Japan Co., Ltd. | 2019-09-06 | 2020-03-03 | |
| Safety, Immunogenicity, and Protective Efficacy of Two Regimens of Radiation Attenuated Plasmodium Falciparum NF54 Sporozoites (PfSPZ Vaccine) During Natural Transmission Season in Healthy African Adults in Mali PfSPZ Vaccine, Normal Saline, artemether 20mg/lumefantrine 120mg (AL) - Malaria | Phase 1 | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | 478 | 2018-05-14 | 2021-08-20 |
| Effect of ACT-451840 Against Early Plasmodium Falciparum Blood Stage Infection in Healthy Subjects ACT-451840:, Plasmodium falciparum-infected human erythrocytes:, Artemether 20 mg and lumefantrine 120mg combination tablet: - Healthy Subjects | Phase 1 | Completed | Idorsia Pharmaceuticals Ltd. | 8 | 2014-06-01 | 2019-08-22 |
| Anti-parasitic Activity and Safety Assessment of SAR97276A in Children With Uncomplicated Malaria SAR97276A, arthemeter + lumefantrine (ACTs) - Malaria | Phase 2 | Terminated | Sanofi | 20 | 2011-10-01 | 2012-12-13 |
| Artemether/Lumefantrine and Vivax Malaria tablets artemether/lumefantrine - Vivax Malaria | Phase 3 | Completed | University of Khartoum | 38 | 2011-09-01 | 2013-01-17 |
| Randomised Efficacy Study of Two Artemether-Lumefantrine Oral Formulations for the Treatment of Uncomplicated P. Falciparum Malaria Artemether/lumefantrine tablets, Artemether/Lumefantrine suspension - Malaria, Falciparum | Phase 4 | Completed | Dafra Pharma | 267 | 2007-05-01 | 2008-01-18 |
| ACT MALI: Treatment of Malaria Based on Combination Therapies Artesunate, Artesunate + Sulfadoxine-Pyrimethamine, arthemether + lumefantrine - Malaria | Phase 4 | Completed | Sanofi | 780 | 2005-07-01 | 2010-02-17 |
| Efficacy of Sulphadoxine-pyrimethamine and Artemisinin-containing Combination Therapy for Malaria Sulfadoxine-pyrimethamine, sulfadoxine-pyrimethamine plus artesunate, lumefantrine plus artemether - Malaria (Uncomplicated) | Phase 4 | Completed | Centers for Disease Control and Prevention | 390 | 2000-01-01 | 2012-09-11 |
Malaria (11) · Malaria, Falciparum (3) · Malaria, Vivax (2) · Recurrence (1)
Novartis Pharmaceuticals (4) · Sanofi (2) · Centers for Disease Control and Prevention (1) · Dafra Pharma (1) · Idorsia Pharmaceuticals Ltd. (1) · National Institute of Allergy and Infectious Diseases (NIAID) (1) · Neopharma Japan Co., Ltd. (1) · U.S. Army Medical Research and Development Command (1) · University of Khartoum (1) · University of Oxford (1)
Kenya (3) · United Kingdom (3) · Burkina Faso (2) · Mali (2) · Australia (1) · Benin (1) · Cambodia (1) · Côte d’Ivoire (1) · Democratic Republic of the Congo (1) · Gabon (1) · Indonesia (1) · Laos (1) · Mozambique (1) · Rwanda (1) · Sudan (1)
Cindy Chu, MD, PhD (1) · Elizabeth A Juma, Dr. (1) · John R MacArthur, MD, MPH (1) · Michelle Lee (1) · Patrick E Duffy, M.D. (1) · Peter B Bloland, DVM, MPVM (1) · Salim Abdulla, MD, PhD (1)
PMID 19102746, PMID 23217037, PMID 27062080, PMID 28472957, PMID 33289099, PMID 39153490