18 completed, 3 terminated, 1 withdrawn. 9 Phase 3, 8 Phase 2, 5 Phase 1, 4 Not applicable, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 9 | Completed 7, Terminated 2 |
| Phase 2 | 8 | Completed 7, Terminated 1 |
| Phase 1 | 5 | Completed 4, Terminated 1 |
| Not applicable | 4 | Completed 4 |
| Phase 4 | 1 | Completed 1 |
Follow Trypanosomiasis, African: new trials by email Literature Review of Trypanosomiasis, African trials Research Report on Trypanosomiasis, African
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 |
|---|---|---|---|---|---|---|
| Screen and Treat Implementation for HAT Control Screen&treat - Sleeping Sickness, Trypanosomiasis, African | Withdrawn | Institute of Tropical Medicine, Belgium | 2024-01-01 | 2024-02-02 | ||
| DDI Study of Single Oral Dose of Acoziborole With Sequential Co-administration of Midazolam and Dextromethorphan Acoziborole, Midazolam, Dextromethorphan - Trypanosomiasis, African | Phase 1 | Completed | Drugs for Neglected Diseases | 20 | 2023-02-09 | 2023-07-17 |
| Pharmacokinetic, Efficacy, Safety and Tolerability Study of a Single Dose of Acoziborole in g-HAT Paediatric Patients Acoziborole - Trypanosomiasis, African, Trypanosoma Brucei Gambiense; Infection | Phase 2 / Phase 3 | Completed | Drugs for Neglected Diseases | 35 | 2022-07-09 | 2026-04-06 |
| Prospective Evaluation of the Specificity of Serological Tests for Human African Trypanosomiasis Serological field test for HAT, malaria rapid test, Immunologic laboratory tests - Human African Trypanosomiasis, Sleeping Sickness | Not applicable | Completed | Institut de Recherche pour le Developpement | 1095 | 2022-06-20 | 2024-04-05 |
| Safety and Tolerability Study of Acoziborole in g-HAT Seropositive Subjects Acoziborole, Placebo - Trypanosomiasis, African, Trypanosoma Brucei Gambiense; Infection | Phase 2 / Phase 3 | Completed | Drugs for Neglected Diseases | 1208 | 2021-12-30 | 2025-03-20 |
| ADME Study of Acoziborole in Healthy Subjects [14C]-acoziborole capsule, 240 mg containing NMT 9.25 kBq (250 nCi) 14C - Trypanosomiases, African | Phase 1 | Completed | Drugs for Neglected Diseases | 6 | 2020-02-05 | 2021-04-27 |
| Fexinidazole in Human African Trypanosomiasis Due to T. b. Rhodesiense Fexinidazole - Trypanosomiasis, African, Sleeping Sickness | Phase 2 / Phase 3 | Completed | Drugs for Neglected Diseases | 45 | 2019-09-29 | 2025-01-30 |
| Diagnostic Tools for Human African Trypanosomiasis Elimination and Clinical Trials: WP3 Post Elimination Monitoring Rapid diagnostic test (RDT); Serological and molecular tests on DBS - Human African Trypanosomiasis, Sleeping Sickness | Not applicable | Completed | Institut de Recherche pour le Developpement | 13747 | 2019-09-01 | 2022-04-15 |
| Diagnostic Tools for Human African Trypanosomiasis Elimination and Clinical Trials: WP2 Passive Case Detection Rapid diagnostic test (RDT), Serological and molecular tests on DBS - African Trypanosomiases, West African; Trypanosomiasis | Not applicable | Completed | Institut de Recherche pour le Developpement | 10700 | 2017-08-01 | 2021-02-21 |
| Diagnostic Tools for Human African Trypanosomiasis Elimination and Clinical Trials: Early Test-of-cure RNA and neopterin detection - African Trypanosomiasis, African; Trypanosomiasis, West | Not applicable | Completed | Institut de Recherche pour le Developpement | 88 | 2017-02-24 | 2021-02-21 |
| Fexinidazole in Human African Trypanosomiasis Due to T.b. Gambiense at Any Stage Fexinidazole - Trypanosomiasis, African, Sleeping Sickness | Phase 3 | Completed | Drugs for Neglected Diseases | 174 | 2016-11-10 | 2025-01-08 |
| Efficacy and Safety of Acoziborole (SCYX-7158) in Patients With Human African Trypanosomiasis Due to T.b. Gambiense Acoziborole - Trypanosomiasis, African, Gambiense Trypanosomiasis | Phase 2 / Phase 3 | Completed | Drugs for Neglected Diseases | 208 | 2016-10-11 | 2025-09-17 |
| Bioequivalence Study - Reference Clinical Fexinidazole Tablet Versus Proposed Market Formulation Fexinidazole - Trypanosomiasis, African | Phase 1 | Completed | Drugs for Neglected Diseases | 30 | 2015-03-01 | 2015-10-08 |
| Pivotal Study of Fexinidazole for Human African Trypanosomiasis in Stage 2 Fexinidazole, Nifurtimox, Eflornithine - Human African Trypanosomiasis (HAT), Sleeping Sickness | Phase 2 / Phase 3 | Completed | Drugs for Neglected Diseases | 394 | 2012-10-01 | 2018-02-20 |
| Human African Trypanosomiasis: First in Man Clinical Trial of a New Medicinal Product, the SCYX-7158 SCYX-7158, Placebo - Trypanosomiasis, Trypanosomiasis, African | Phase 1 | Completed | Drugs for Neglected Diseases | 136 | 2012-02-01 | 2015-09-18 |
| Multiple Dose Study to Evaluate Security, Tolerance and Pharmacokinetic of Fexinidazole (Drug Candidate for Human African Trypanosomiasis) Administered With a Loading Dose and With Food Tablets Fexinidazole, Placebo - Trypanosomiasis, African | Phase 1 | Terminated | Drugs for Neglected Diseases | 30 | 2011-09-01 | 2017-03-31 |
| Clinical Study to Assess the Tolerability, Feasibility and Effectiveness of Nifurtimox and Eflornithine (NECT) for the Treatment of Trypanosoma Brucei Gambiense Human African Trypanosomiasis (HAT) in the Meningo-encephalitic Phase Nifurtimox-Eflronithine Combination Treatment (NECT) - Human African Trypanosomiasis | Phase 4 | Completed | Drugs for Neglected Diseases | 630 | 2009-04-01 | 2013-05-31 |
| Trial of DB289 for the Treatment of Stage I African Trypanosomiasis DB289, Pentamidine - African Trypanosomiasis | Phase 2 | Completed | Immtech Pharmaceuticals, Inc | 111 | 2003-02-01 | 2008-12-08 |
| Eflornithine + Nifurtimox Late-Stage Human African Trypanosomiasis (HAT)in West Nile, Uganda Eflornithine plus Nifurtimox combination therapy - Trypanosomiasis, African | Phase 2 / Phase 3 | Terminated | Epicentre | 31 | 2002-10-01 | 2007-06-21 |
| A Trial of DB289 for the Treatment of Stage I African Trypanosomiasis DB289 - Trypanosomiasis, African | Phase 2 | Completed | Immtech Pharmaceuticals, Inc | 30 | 2001-08-01 | 2008-12-05 |
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Infections (7) · Trypanosomiasis (6) · Disease (4) · Hypersensitivity (3) · Neglected Diseases (2) · Parasitic Diseases (1) · Protozoan Infections (1)
Euglenozoa Infections (22) · Vector Borne Diseases (22) · Parasitic Diseases (21) · Protozoan Infections (21) · Trypanosomiasis (16) · Infections (15) · Pathologic Processes (6) · Pathological Conditions, Signs and Symptoms (6) · Immune System Diseases (3) · Disease Attributes (2)
Eflornithine (5) · fexinidazole (5) · Nifurtimox (4) · Rapid Diagnostic Tests (2) · SCYX 7158 (2) · Dextromethorphan (1) · Melarsoprol (1) · Midazolam (1) · Pentamidine (1)
Drugs for Neglected Diseases (13) · Institut de Recherche pour le Developpement (4) · Epicentre (2) · Immtech Pharmaceuticals, Inc (2) · Institute of Tropical Medicine, Belgium (1)
Democratic Republic of the Congo (9) · Guinea (6) · Republic of the Congo (5) · Côte d’Ivoire (3) · France (3) · Uganda (3) · Angola (1) · Burkina Faso (1) · Central African Republic (1) · Malawi (1) · Malaysia (1) · United Kingdom (1)
Antoine Tarral, MD (2) · Gerardo Priotto, MD, MPH (2) · Veerle Lejon, PhD (2) · Victor Kande, MD (2) · Christian Burri, MSc, PhD (1) · Digas Ngolo Tete, MPH (1) · Els Torreele, PhD (1) · Enock Matovu, Prof (1) · Gerardo Priotto, MD MPH (1) · Johannes Blum, MD (1) · Lionel Hovsepian, MD (1) · Mamadou Camara, PhD (1) · Martial N'Djetchi Kassi (1) · Oumou Camara (1)
PMID 26881924, PMID 19559476, PMID 23209861, PMID 29113731, PMID 31986140, PMID 34460829, PMID 34534223, PMID 34748572, PMID 36436279, PMID 36460027, PMID 36763327, PMID 36941656, PMID 38978124, PMID 40288399, PMID 40288400, PMID 41021650