13 completed, 1 not yet recruiting, 1 terminated, 1 unknown. 6 Phase 1, 5 Phase 3, 4 Phase 2, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 6 | Completed 6 |
| Phase 3 | 5 | Completed 3, Terminated 1, Unknown 1 |
| Phase 2 | 4 | Completed 3, Unknown 1 |
| Phase 4 | 1 | Completed 1 |
Follow Nifurtimox: new trials by email Literature Review of Nifurtimox trials Research Report on Nifurtimox
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 |
|---|---|---|---|---|---|---|
| An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About the Risk of Pregnancy Complications and About the Mother's and Baby's Health Nifurtimox (BAYA2502) - Chagas Disease | Not yet recruiting | Bayer | 50 | 2026-12-31 | 2026-07-06 | |
| New Therapies and Biomarkers for Chagas Infection Benznidazole, Nifurtimox - Trypanosoma Cruzi Infection, Chagas Disease | Phase 2 | Completed | University of Texas, El Paso | 450 | 2019-12-18 | 2024-07-17 |
| Study to Assess the Food Effect on the Pharmacokinetics of Nifurtimox Tablets in Chronic Chagas' Patients - Dietary Habits Study Nifurtimox (Lampit, BAYA2502) - Chagas' Disease | Phase 1 | Completed | Bayer | 36 | 2019-06-10 | 2020-12-30 |
| Study on Benefits of Therapy With Nifurtimox in Chagas Disease, a Parasitic Illness Mostly Transmitted to Humans by a Bug, Using Information From Patient Medical Records in Argentina Lampit (Nifurtimox, BAYA2502) - Chagas' Disease | Completed | Bayer | 3000 | 2018-12-14 | 2021-04-08 | |
| Study to Assess Bioequivalence of a New Nifurtimox Oral Tablet Formulation Nifurtimox (Lampit, BAYA2502)_Test, Nifurtimox (Lampit, BAYA2502)_Reference - Bioequivalence | Phase 1 | Completed | Bayer | 24 | 2018-12-05 | 2020-06-11 |
| Study Will Evaluate the Relative Bioavailability, Safety, and Tolerability of Single Doses of Nifurtimox 30 mg Tablets Exhibiting Different in Vitro Dissolution Characteristics, and to Evaluate the Relative Bioavailability of Nifurtimox 30 mg and 120 mg Nifurtimox (Lampit, BAYA2502) - Chagas Disease | Phase 1 | Completed | Bayer | 48 | 2018-06-14 | 2019-12-12 |
| A Study to Learn How Well Nifurtimox Works and How Safe it is in Children Aged 0 to 17 Years With Chagas' Disease, an Inflammatory, Infectious Disease Caused by the Parasite Trypanosoma Cruzi Nifurtimox (Lampit, BAYA2502), Placebo - Chagas Disease | Phase 3 | Completed | Bayer | 330 | 2016-01-27 | 2024-08-19 |
| Study to Assess the Food Effect on the Pharmacokinetics of Nifurtimox Tablets in Chronic Chagas' Patients Nifurtimox (BAYa2502) - Chagas Disease | Phase 1 | Completed | Bayer | 36 | 2015-12-01 | 2016-11-15 |
| CHICAMOCHA 3 - Equivalence of Usual Interventions for Trypanosomiasis (EQUITY) Nifurtimox, Benznidazole, Placebo - Chagas Disease | Phase 2 / Phase 3 | Unknown | Universidad Autónoma de Bucaramanga | 500 | 2015-08-01 | 2017-07-21 |
| Study to Assess Bioequivalence of 30 and 120 mg Nifurtimox Tablets in Chronic Chagas' Patients Nifurtimox (BAYa2502) (4 x 30 mg tablet), Nifurtimox (BAYa2502) (slurry of 4 x 30 mg tablets in tap water), Nifurtimox (BAYa2502) (120 mg tablet) - Chagas Disease | Phase 1 | Completed | Bayer | 37 | 2013-11-01 | 2015-10-16 |
| 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 |
| 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 |
| Study of Nifurtimox to Treat Refractory or Relapsed Neuroblastoma or Medulloblastoma Nifurtimox, Cyclophosphamide, Topotecan - Neuroblastoma, Medulloblastoma | Phase 2 | Completed | Giselle Sholler | 112 | 2008-01-14 | 2024-08-06 |
| Safety Study of Nifurtimox for Relapsed or Refractory Neuroblastoma Nifurtimox - Neuroblastoma | Phase 1 | Completed | University of Vermont | 20 | 2006-11-01 | 2009-10-23 |
| Randomized Clinical Trial of Three Drug Combinations for Late-Stage Gambiense Human African Trypanosomiasis melarsoprol 1.8 mg/kg/d, 10d + nifurtimox 15/20 mg/kg/d, 10d, melarsoprol 1.8 mg/kg/d, 10d + eflornithine 400 mg/kg/d, 7d, nifurtimox 15/20 mg/kg/d 10d + eflornithine 400 mg/kg/d 7d - Trypanosomiasis, African | Phase 3 | Terminated | Epicentre | 435 | 2001-03-01 | 2006-05-26 |
| Efficacy - Safety of Eflornithine-Nifurtimox Combination Versus Eflornithine to Treat Human African Trypanosomiasis Eflornithine, Nifurtimox - Trypanosomiasis, African | Phase 3 | Completed | Drugs for Neglected Diseases | 280 | 2016-09-29 |
Chagas Disease (9) · Trypanosomiasis, African (4) · Neuroblastoma (2) · Medulloblastoma (1) · Parasitic Diseases (1) · Recurrence (1) · Trypanosomiasis (1)
Bayer (8) · Drugs for Neglected Diseases (3) · Epicentre (1) · Giselle Sholler (1) · Universidad Autónoma de Bucaramanga (1) · University of Texas, El Paso (1) · University of Vermont (1)
Argentina (8) · Bolivia (3) · Colombia (3) · Republic of the Congo (3) · United States (3) · Democratic Republic of the Congo (2) · Central African Republic (1) · Chile (1) · El Salvador (1) · Germany (1) · Guatemala (1) · Honduras (1) · Mexico (1) · Spain (1) · Uganda (1)
Gerardo Priotto, MD, MPH (2) · Giselle Sholler, MD (2) · Els Torreele, PhD (1) · Faustino Torrico, M.D., Ph.D (1) · Igor C Almeida, D.Sc. (1) · Joaquim Gascon, M.D., Ph.D (1) · Johannes Blum, MD (1) · Juan C Villar, MD, PhD (1) · Victor Kande, MD (1)
PMID 34265407, PMID 19559476, PMID 23209861, PMID 29113731, PMID 31307503, PMID 31986140, PMID 33412557, PMID 34606501, PMID 34748572, PMID 34972765, PMID 36975790, PMID 37352322, PMID 42772313, PMID 8937280, PMID 9790423
U01AI129783 (1)