Clinical trials: African Trypanosomiasis
Human African Trypanosomiasis (HAT), Sleeping Sickness
Pivotal Study of Fexinidazole for Human African Trypanosomiasis in Stage 2
This clinical trial is designed to prove the efficacy and safety of Fexinidazole as an oral treatment for human african trypanosomiasis in advanced stage. The Fexinidazole is compared to reference treatment NECT.
- Trial name
- NCT01685827
- Testing
- Fexinidazole, Nifurtimox, Eflornithine
- Where
- 10 sites in Central African Republic, Democratic Republic of the Congo and 1 more
- Volunteers
- 394 people
- Sponsor
- Drugs for Neglected Diseases
Trypanosomiasis, African
A Trial of DB289 for the Treatment of Stage I African Trypanosomiasis
Human African Trypanosomiasis or sleeping sickness has made a spectacular return during the last decade, and in many places the demand largely surpasses the capacities of the treatment centers.
- Trial name
- NCT00802594
- Testing
- DB289
- Where
- 2 sites in Angola, Republic of the Congo
- Volunteers
- 30 people
- Sponsor
- Immtech Pharmaceuticals, Inc
Trypanosomiasis, African, Sleeping Sickness
Fexinidazole in Human African Trypanosomiasis Due to T. b. Rhodesiense
The ultimate goal of this study is to show that fexinidazole offers an alternative over the existing treatments of Human African trypanosomiasis due to Trypanosoma brucei rhodesiense (r-HAT): melarsoprol in patients with stage 2…
- Conditions
- Trypanosomiasis, African, Sleeping Sickness, Trypanosoma Brucei Rhodesiense; Infection
- Trial name
- NCT03974178
- Testing
- Fexinidazole
- Where
- 2 sites in Malawi, Uganda
- Volunteers
- 45 people
- Sponsor
- Drugs for Neglected Diseases
Trypanosomiasis, African
Efficacy - Safety of Eflornithine-Nifurtimox Combination Versus Eflornithine to Treat Human African Trypanosomiasis
The purpose of this study is to compare the therapeutic combination of I.V. eflornithine + oral nifurtimox to the standard IV eflornithine regimen in terms of therapeutic efficacy and clinical safety, in patients suffering from…
- Trial name
- NCT00146627
- Testing
- Eflornithine, Nifurtimox
- Where
- 4 sites in Democratic Republic of the Congo, Republic of the Congo
- Volunteers
- 280 people
- Sponsor
- Drugs for Neglected Diseases
Trypanosomiasis, African
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
This trial will study the tolerability and pharmacokinetic of fexinidazole using two different dosage regimen of repeated administrations.
- Trial name
- NCT01483170
- Testing
- Tablets Fexinidazole
- Where
- France
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Drugs for Neglected Diseases
Sleeping Sickness, Trypanosomiasis, African
Screen and Treat Implementation for HAT Control
Human African Trypanosomiasis (HAT), or sleeping sickness, is one of the parasitic diseases targeted for interruption of transmission by 2030 by the WHO.
- Trial name
- NCT05645822
- Testing
- Screen&treat
- Sponsor
- Institute of Tropical Medicine, Belgium
Human African Trypanosomiasis
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
Multicenter, open label, uncontrolled phase IIIb study of therapeutic use of the combination of nifurtimox and eflornithine (NECT) for the treatment of Trypanosoma brucei gambiense human African trypanosomiasis (HAT) in the…
- Trial name
- NECT-FIELD (NCT00906880)
- Testing
- Nifurtimox-Eflronithine Combination Treatment (NECT)
- Where
- 6 sites in Republic of the Congo
- Volunteers
- 630 people
- Sponsor
- Drugs for Neglected Diseases
Human African Trypanosomiasis (HAT)
Efficacy and Safety of Fexinidazole in Children at Least 6 Years Old and Weighing Over 20 kg With Human African Trypanosomiasis (HAT) Due to T.b. Gambiense: a Prospective, Multicentre, Open Study, plug-in to the Pivotal Study
The aim of the study is to assess the efficacy and safety of an oral regimen of fexinidazole (once daily for 10 days) in the treatment of stage 1 and stage 2 T.b.
- Trial name
- NCT02184689
- Testing
- fexinidazole
- Where
- Democratic Republic of the Congo
- Volunteers
- 125 people
- Sponsor
- Drugs for Neglected Diseases
PK in Healthy Volunteers
Fexinidazole (1200mg) Bioavailability Under Different Food Intake Conditions
The present study is designed to assess the impact of concomitant food intake on the relative bioavailability of a single oral fexinidazole tablet administration.
- Trial name
- NCT01340157
- Testing
- Fexinidazole
- Where
- France
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Drugs for Neglected Diseases
Trypanosomiases, African
ADME Study of Acoziborole in Healthy Subjects
This is a single centre, open-label, single group, non-randomised, single oral dose study in healthy male subjects designed to assess the mass balance recovery, PK, metabolite profile and metabolite identification, and…
- Trial name
- NCT04270981
- Testing
- [14C]-acoziborole capsule, 240 mg containing NMT 9.25 kBq (250 nCi) 14C
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Drugs for Neglected Diseases
Trypanosomiasis, African
Eflornithine + Nifurtimox Late-Stage Human African Trypanosomiasis (HAT)in West Nile, Uganda
This case series study follows on a terminated randomised clinical trial in a nearby location of Uganda, in which the combination of eflornithine + nifurtimox showed very promising efficacy and safety.
- Trial name
- NECS (NCT00489658)
- Testing
- Eflornithine plus Nifurtimox combination therapy
- Where
- Uganda
- Volunteers
- 31 people
- Sponsor
- Epicentre
Human African Trypanosomiasis
Human African Trypanosomiasis: First in Man Clinical Trial of a New Medicinal Product, the Fexinidazole
This study is aimed at assessing the tolerability and pharmacokinetic parameters of the fexinidazole in healthy volunteers. In animal models of both acute and chronic experimental Trypanosomiasis infections, fexinidazole shows…
- Trial name
- NCT00982904
- Where
- France
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Drugs for Neglected Diseases
Trypanosoma Brucei Rhodesiense; Infection
A Retrospective Analysis of Suramin Treatment for Stage 1 TBR
The study will include TBR HAT patients treated with suramin between 2000 and 2020 at three sites in Uganda and Malawi A natural history cohort composed of source data from approximately 200 patients from a published…
- Trial name
- NCT06060600
- Where
- United States
- Volunteers
- 345 people
- Sponsor
- Paxmedica
African Trypanosomiasis
Trial of DB289 for the Treatment of Stage I African Trypanosomiasis
Human African Trypanosomiasis or sleeping sickness has made a spectacular return during the last decade, and in many places the demand largely surpasses the capacities of the treatment centers.
- Trial name
- NCT00803933
- Testing
- DB289, Pentamidine
- Where
- 2 sites in Republic of the Congo
- Volunteers
- 111 people
- Sponsor
- Immtech Pharmaceuticals, Inc
Trypanosomiasis, African, Gambiense Trypanosomiasis
Efficacy and Safety of Acoziborole (SCYX-7158) in Patients With Human African Trypanosomiasis Due to T.b. Gambiense
The goal of this study is to assess efficacy and safety of acoziborole in adult participants with Trypanosoma brucei gambiense (T.b.
- Conditions
- Trypanosomiasis, African, Gambiense Trypanosomiasis, Sleeping Sickness
- Trial name
- OXA002 (NCT03087955)
- Testing
- Acoziborole
- Where
- 12 sites in Democratic Republic of the Congo, Guinea
- Volunteers
- 208 people
- Sponsor
- Drugs for Neglected Diseases
Trypanosomiasis, African
Randomized Clinical Trial of Three Drug Combinations for Late-Stage Gambiense Human African Trypanosomiasis
The treatment human African trypanosomiasis (HAT) in the meningoencephalitic phase relies on two molecules officially registered: melarsoprol, the most commonly used, has a poor safety profile and is becoming ineffective due to…
- Trial name
- NCT00330148
- Testing
- 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
- Where
- Uganda
- Volunteers
- 435 people
- Sponsor
- Epicentre
Human African Trypanosomiasis
Prospective Evaluation of an RDT to Screen for Gambiense HAT and Diagnose P. Falciparum Malaria
A prototype rapid diagnostic test (RDT) to simultaneously screen for gambiense human African trypanosomiasis (HAT) and diagnose P. falciparum malaria (the "HAT/malaria combo") has recently been developed.
- Trial name
- NCT03394976
- Testing
- No intervention
- Volunteers
- healthy volunteers welcome
- Sponsor
- Foundation for Innovative New Diagnostics, Switzerland
Trypanosomiasis, African
DDI Study of Single Oral Dose of Acoziborole With Sequential Co-administration of Midazolam and Dextromethorphan
To assess Drug drug interactions between Acoziborole and Dextromethorphan and Midazolam in healthy male volunteers.
- Trial name
- OXA-07 (NCT05947604)
- Testing
- Acoziborole, Midazolam, Dextromethorphan
- Where
- Malaysia
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Drugs for Neglected Diseases
Human African Trypanosomiasis
Assessment of Recombinant HAT-RDT Specificity
Human African trypanosomiasis HAT, or sleeping sickness, is a tropical disease caused mainly by the parasite Trypanosoma brucei gambiense (gHAT).
- Trial name
- NCT05637632
- Where
- Democratic Republic of the Congo
- Volunteers
- 1,504 people, healthy volunteers welcome
- Sponsor
- Institute of Tropical Medicine, Belgium
Trypanosomiasis; African, Due to Trypanosoma Brucei Gambiense, Gambiense
Stop Transmission of Gambiense Human African Trypanosomiasis
This protocol describes both the epidemiological study which aims at assessing whether over a three-year period a zero prevalence can be achieved when implementing a screen \& treat approach with acoziborole, as well as a nested…
- Trial name
- STROgHAT (NCT07789743)
- Testing
- Acoziborole
- Where
- Democratic Republic of the Congo
- Volunteers
- 2,500 people
- Sponsor
- Institute of Tropical Medicine, Belgium