Clinical trials: Trypanosomiasis, African
Trypanosomiasis, African
Bioequivalence Study - Reference Clinical Fexinidazole Tablet Versus Proposed Market Formulation
Phase 1 bioequivalence (BE) study. This study is for regulatory purpose to determine BE of the tablet formulation used in the clinical trials and the final marketed tablet formulation under fed condition.
- Trial name
- NCT02571062
- Testing
- Fexinidazole
- Where
- France
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Drugs for Neglected Diseases
Trypanosomiasis, African, Trypanosoma Brucei Gambiense; Infection
Pharmacokinetic, Efficacy, Safety and Tolerability Study of a Single Dose of Acoziborole in g-HAT Paediatric Patients
Acoziborole has been studied in an open-label pivotal Phase II/III trial (DNDi-OXA-02-HAT) in the DRC and Guinea. As the numbers of reported cases diminish, resources for surveillance and specialised screening will also taper.
- Conditions
- Trypanosomiasis, African, Trypanosoma Brucei Gambiense; Infection, Sleeping Sickness
- Trial name
- OXA005 (NCT05433350)
- Testing
- Acoziborole
- Where
- 6 sites in Democratic Republic of the Congo, Guinea
- Volunteers
- 35 people
- Sponsor
- Drugs for Neglected Diseases
Trypanosomiasis, Trypanosomiasis, African
Human African Trypanosomiasis: First in Man Clinical Trial of a New Medicinal Product, the SCYX-7158
This study is aimed at assessing the tolerability and pharmacokinetic parameters of SCYX-7158 in healthy volunteers. In animal models of both acute and chronic experimental Trypanosomiasis infections, SCYX-7158 shows highly…
- Conditions
- Trypanosomiasis, Trypanosomiasis, African, Protozoan Infections, Parasitic Diseases
- Trial name
- NCT01533961
- Testing
- SCYX-7158
- Where
- 2 sites in France
- Volunteers
- 136 people, healthy volunteers welcome
- Sponsor
- Drugs for Neglected Diseases
African Trypanosomiases, West African; Trypanosomiasis
Diagnostic Tools for Human African Trypanosomiasis Elimination and Clinical Trials: WP2 Passive Case Detection
The study determines the diagnostic performance and cost of rapid diagnostic tests (RDTs) performed on human African trypanosomiasis clinical suspects in peripheral health centres, whether or not followed by serological and/or…
- Conditions
- African Trypanosomiases, West African; Trypanosomiasis, Sleeping Sickness; West African, Trypanosoma Brucei Gambiense; Infection
- Trial name
- DiTECT-WP2 (NCT03356665)
- Testing
- Rapid diagnostic test (RDT), Serological and molecular tests on DBS
- Where
- 3 sites in Côte d’Ivoire, Democratic Republic of the Congo and 1 more
- Volunteers
- 10,700 people
- Sponsor
- Institut de Recherche pour le Developpement
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
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
Trypanosomiasis, African, Trypanosoma Brucei Gambiense; Infection
Safety and Tolerability Study of Acoziborole in g-HAT Seropositive Subjects
Human African trypanosomiasis (HAT) or sleeping sickness is a tropical disease which is endemic in sub-Saharan Africa. Most cases of HAT are due to the parasite Trypanosoma brucei gambiense (T.b.
- Conditions
- Trypanosomiasis, African, Trypanosoma Brucei Gambiense; Infection, Sleeping Sickness
- Trial name
- OXA004 (NCT05256017)
- Testing
- Acoziborole
- Where
- 7 sites in Democratic Republic of the Congo, Guinea
- Volunteers
- 1,208 people
- Sponsor
- Drugs for Neglected Diseases
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
Human African Trypanosomiasis (HAT)
Efficacy and Safety of Fexinidazole in Patients With Stage 1 or Early Stage 2 Human African Trypanosomiasis (HAT) Due to T.b. Gambiense: a Prospective, Multicentre, Open-label Cohort Study, plug-in to the Pivotal Study
The purpose of this study is to demonstrate the treatment success of fexinidazole, at one year follow-up visit, in HAT stage 1 and early stage 2 patients.
- Trial name
- NCT02169557
- Testing
- Fexinidazole
- Where
- Democratic Republic of the Congo
- Volunteers
- 230 people
- Sponsor
- Drugs for Neglected Diseases
Human African Trypanosomiasis, Sleeping Sickness
Prospective Evaluation of the Specificity of Serological Tests for Human African Trypanosomiasis
This study evaluates and compares the diagnostic specificity of 5 serological field tests for screening of the population at risk for human African trypanosomiasis due to Trypanosoma brucei gambiense.
- Conditions
- Human African Trypanosomiasis, Sleeping Sickness, Trypanosoma Brucei Gambiense; Infection, West African Sleeping Sickness
- Trial name
- SpeSerTryp (NCT05466630)
- Testing
- Serological field test for HAT, malaria rapid test, Immunologic laboratory tests
- Where
- 2 sites in Côte d’Ivoire, Guinea
- Volunteers
- 1,095 people, healthy volunteers welcome
- Sponsor
- Institut de Recherche pour le Developpement
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
African Trypanosomiasis, African; Trypanosomiasis, West
Diagnostic Tools for Human African Trypanosomiasis Elimination and Clinical Trials: Early Test-of-cure
The study validates the diagnostic performance of cerebrospinal fluid neopterin quantification and of blood and cerebrospinal fluid trypanosomal spliced leader RNA detection for assessing outcome after treatment of human African…
- Conditions
- African Trypanosomiasis, African; Trypanosomiasis, West, Sleeping Sickness; West African, Trypanosoma Brucei Gambiense; Infection
- Trial name
- DiTECT-WP4 (NCT03112655)
- Testing
- RNA and neopterin detection
- Where
- Democratic Republic of the Congo
- Volunteers
- 88 people
- Sponsor
- Institut de Recherche pour le Developpement
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
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
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
Trypanosomiasis, African, Sleeping Sickness
Fexinidazole in Human African Trypanosomiasis Due to T.b. Gambiense at Any Stage
This study evaluates the effectiveness of fexinidazole administered to patients with human African trypanosomiasis due to T. b. gambiense (g-HAT) at all stages of the disease.
- Conditions
- Trypanosomiasis, African, Sleeping Sickness, Trypanosomiasis; Gambian
- Trial name
- NCT03025789
- Testing
- Fexinidazole
- Where
- 8 sites in Democratic Republic of the Congo, Guinea
- Volunteers
- 174 people
- Sponsor
- Drugs for Neglected Diseases
Human African Trypanosomiasis
Stop Transmission of Gambiense Human African Trypanosomiasis (STROgHAT)
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 (NCT06356974)
- Testing
- Treatment of seropositive individuals (positive serology test, but parasitology not confirmed)
- Volunteers
- 2,500 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
Visceral Leishmaniasis, Human African Trypanosomiasis
Rapid Diagnostic Tests and Clinical/Laboratory Predictors of Tropical Diseases In Patients With Persistent Fever in Cambodia, Nepal, Democratic Republic of the Congo and Sudan (NIDIAG-Fever)
Tropical fevers have been a diagnostic challenge from the antiquity. Nowadays, despite the availability of good diagnostic capacities, undifferentiated febrile illnesses continue to be a thorny problem for travel physicians.
- Conditions
- Visceral Leishmaniasis, Human African Trypanosomiasis, Enteric Fever, Melioidosis
- Trial name
- NCT01766830
- Testing
- rk28 ICT, IT LEISH (rK39), Immunochromatographic HAT test
- Where
- 7 sites in Cambodia, Democratic Republic of the Congo and 2 more
- Volunteers
- 1,927 people
- Sponsor
- University Hospital, Geneva
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