A Phase 2/3 interventional study of Fexinidazole in Trypanosomiasis, African, Sleeping Sickness and Trypanosoma Brucei Rhodesiense; Infection, sponsored by Drugs for Neglected Diseases. Completed at 2 sites in 2 countries. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2025-01-30.
Sponsored by Drugs for Neglected Diseases · Phase 2/3, Interventional, and Treatment
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 r-HAT and suramin in patients with stage 1 r-HAT. The main questions it aims to answer are:
Participants will receive fexinidazole oral treatment for 10 days. Regular blood draws and lumbar punctures will be performed over 12 months to confirm the cure of the disease. Other assessments will include the recording of adverse events, signs and symptoms of the disease, laboratory tests, vital signs, electrocardiograms.
26 studies on the registry are indexed under Trypanosomiasis, African; 1 is open to participants now.
This study's enrollment of 45 is below the median of 155 across 24 interventional studies indexed under Trypanosomiasis, African.
Browse Trypanosomiasis, African studies →Drugs for Neglected Diseases is the lead sponsor of 58 studies on the registry; 3 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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Studies often ask for 60 or 70 and above. Your doctor gives the score.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with stage 1 r-HAT were patients without trypanosomes in the cerebrospinal fluid (CSF) but with trypanosomes in the blood and/or lymph and CSF white blood cells (WBC) ≤5 cells/µL. Patients were to receive fexinidazole orally for 10 days.
Drug: Fexinidazole
Patients with stage 2 r-HAT were patients with trypanosomes in the CSF (and/or in blood/lymph) and/or CSF WBC \>5 cells/µL. Patients were to receive fexinidazole orally for 10 days.
Drug: Fexinidazole
Tablets of 600 mg; Participants with a weight between 20 and 34 kg received 1200 mg (2 tablets) for 4 days, then 600 mg (1 tablet) for 6 days (with food); Participants with a weight of 35 kg and above received 1800 mg (3 tablets) for 4 days, then 1200 mg (2 tablets) for 6 days (with food)
Percentage of Evaluable Patients With Stage 2 r-HAT Who Died by the End of Hospitalization, Considering Only Deaths Possibly Related to r-HAT or Fexinidazole
The percentage of patients who died between the first intake of fexinidazole until the End-of-Hospitalization Visit (Day 12-18), considering only deaths possibly related to r-HAT or study treatment as assessed by the Data Safety Monitoring Board (DSMB), was calculated. The World Health Organization(WHO) verbal autopsy questionnaire was used since anatomopathological techniques were not available at the study sites (unless the death occurred at the hospital, in which case the investigator was present). In case of death that was not related to r-HAT nor to the study treatment during the hospitalization, the patient is considered as non-evaluable for efficacy purposes. Any patient who left the hospital without being medically discharged by the site Investigator before the planned End-of-Hospitalization Visit, and for whom no outcome could be retrieved, is also to be considered as non-evaluable.
Time frame: 12 to 18 days after start of treatment
Percentage of Evaluable Patients With Stage 2 r-HAT, Whose Treatment Outcome is a Failure at the End of Hospitalization
Treatment outcome at end of hospitalization (Day 12-18) is categorized as success or failure. Failure is defined as any of the following: presence of trypanosomes in any body fluid at end of treatment (Day 11), death related to r-HAT or fexinidazole at end of hospitalization according to the DSMB, or absence of clinical improvement leading to the use of rescue medication. Unrelated deaths are neither success nor failure (the patient is considered non-evaluable for efficacy purposes).
Time frame: 12 to 18 days after start of treatment
Percentage of Evaluable Patients With Stage 2 r-HAT, Whose Treatment Outcome is a Failure at 12 Months
Treatment outcome at test of cure (Month 12) is categorized as success or failure. Failure is defined as any of the following: presence of trypanosomes in any body fluid, death related to r-HAT or fexinidazole according to the DSMB, absence of clinical improvement leading to the use of rescue medication, or WBC count in the CSF \>20 cells/μL which was unlikely due to causes other than HAT. Unrelated deaths are neither success nor failure (the patient is considered non-evaluable for efficacy purposes).
Time frame: 12 months after start of treatment
Percentage of Evaluable Patients With Stage 1 r-HAT, Whose Treatment Outcome is a Failure at the End of Hospitalization
Treatment outcome at end of hospitalization (Day 12-18) is categorized as success or failure. Failure is defined as any of the following: presence of trypanosomes in any body fluid at end of treatment (Day 11), death related to r-HAT or fexinidazole at end of hospitalization according to the DSMB, or absence of clinical improvement leading to the use of rescue medication. Unrelated deaths are neither success nor failure (the patient is considered non-evaluable for efficacy purposes).
Time frame: 12 to 18 days after start of treatment
Percentage of Evaluable Patients With Stage 1 r-HAT, Whose Treatment Outcome is a Failure at 12 Months
Treatment outcome at test of cure (Month 12) is categorized as success or failure. Failure is defined as any of the following: presence of trypanosomes in any body fluid, death related to r-HAT or fexinidazole according to the DSMB, absence of clinical improvement leading to the use of rescue medication, or WBC count in the CSF \>20 cells/μL which was unlikely due to causes other than HAT. Unrelated deaths are neither success nor failure (the patient is considered non-evaluable for efficacy purposes).
Time frame: 12 months after start of treatment
Percentage of Evaluable Patients With Any r-HAT Stage Who Died by the End of Hospitalization, Considering Only Deaths Possibly Related to r-HAT or Fexinidazole
The percentage of patients who died between the first intake of fexinidazole until the End-of-Hospitalization Visit (Day 12-18), considering only deaths possibly related to r-HAT or study treatment as assessed by the DSMB, was calculated. The WHO verbal autopsy questionnaire was used since anatomopathological techniques were not available at the study sites (unless the death occurred at the hospital, in which case the investigator was present). In case of death that was not related to r-HAT nor to the study treatment during the hospitalization, the patient is considered as non-evaluable for efficacy purposes. Any patient who left the hospital without being medically discharged by the site Investigator before the planned End-of-Hospitalization Visit, and for whom no outcome could be retrieved, is also to be considered as non-evaluable.
Time frame: 12 to 18 days after start of treatment
Percentage of Evaluable Patients With Any r-HAT Stage, Whose Treatment Outcome is a Failure at the End of Hospitalization
Treatment outcome at end of hospitalization (Day 12-18) is categorized as success or failure. Failure is defined as any of the following: presence of trypanosomes in any body fluid at end of treatment (Day 11), death related to r-HAT or fexinidazole at end of hospitalization according to the DSMB, or absence of clinical improvement leading to the use of rescue medication. Unrelated deaths are neither success nor failure (the patient is considered non-evaluable for efficacy purposes).
Time frame: 12 to 18 days after start of treatment
Percentage of Evaluable Patients With Any r-HAT Stage, Whose Treatment Outcome is a Failure at 12 Months
Treatment outcome at test of cure (Month 12) is categorized as success or failure. Failure is defined as any of the following: presence of trypanosomes in any body fluid, death related to r-HAT or fexinidazole according to the DSMB, absence of clinical improvement leading to the use of rescue medication, or WBC count in the CSF \>20 cells/μL which was unlikely due to causes other than HAT. Unrelated deaths are neither success nor failure (the patient is considered non-evaluable for efficacy purposes).
Time frame: 12 months after start of treatment
Number of Participants With Any AE (Including Abnormal Laboratory or ECG Finding if Considered Clinically Significant) Until the End of Hospitalization
Treatment-emergent AEs during the observation period were recorded from the first intake of fexinidazole (Day 1) until the End-of-Hospitalization Visit (between Day 12 and Day 18).
Time frame: 12 to 18 days (between Day 1 and Day 12-18)
Number of Participants With Any AE Considered as Serious Until the End of the Follow-up Period
Treatment-emergent AEs considered as serious were collected from the first intake of fexinidazole (Day 1) until the End-of-Study Visit (Month 12). An AE was considered as serious if resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability or incapacity, was a congenital anomaly or birth defect, or was an important medical event.
Time frame: 12 months (between Day 1 and Month 12)
Number of Participants With Any AE Considered as Possibly Related to Fexinidazole Until the End of the Follow-up Period
Treatment-emergent AEs considered as possibly related to fexinidazole were collected from the first intake of fexinidazole (Day 1) until the End-of-Study Visit (Month 12).
Time frame: 12 months (between Day 1 and Month 12)
The study was conducted at 1 center in Malawi (Rumphi District Hospital) and 1 center in Uganda (Lwala Hospital). 46 participants were screened and signed informed consent. The screening pool was enlarged to other hospitals and centres in Uganda, Rumphi/Mzimba North District (Malawi), and Nkhotakota District (Malawi), from where patients could be referred to Lwala and Rumphi Hospitals for treatment. 45 participants were enrolled between 29 Sep 2019 and 17 Nov 2021.
| Milestone | Patients With Stage 1 r-HAT | Patients With Stage 2 r-HAT |
|---|---|---|
| Started | 10 | 35 |
| Completed | 10 | 34 |
| Not completed | 0 | 1 |
| Withdrew: Death | 0 | 1 |
The percentage of patients who died between the first intake of fexinidazole until the End-of-Hospitalization Visit (Day 12-18), considering only deaths possibly related to r-HAT or study treatment as assessed by the Data Safety Monitoring Board (DSMB), was calculated. The World Health Organization(WHO) verbal autopsy questionnaire was used since anatomopathological techniques were not available at the study sites (unless the death occurred at the hospital, in which case the investigator was present). In case of death that was not related to r-HAT nor to the study treatment during the hospitalization, the patient is considered as non-evaluable for efficacy purposes. Any patient who left the hospital without being medically discharged by the site Investigator before the planned End-of-Hospitalization Visit, and for whom no outcome could be retrieved, is also to be considered as non-evaluable.
| percentage of participants | Patients With Stage 2 r-HAT |
|---|---|
| Percentage of Evaluable Patients With Stage 2 r-HAT Who Died by the End of Hospitalization, Considering Only Deaths Possibly Related to r-HAT or Fexinidazole | 0 (0 to 8.43) |
Treatment outcome at end of hospitalization (Day 12-18) is categorized as success or failure. Failure is defined as any of the following: presence of trypanosomes in any body fluid at end of treatment (Day 11), death related to r-HAT or fexinidazole at end of hospitalization according to the DSMB, or absence of clinical improvement leading to the use of rescue medication. Unrelated deaths are neither success nor failure (the patient is considered non-evaluable for efficacy purposes).
| percentage of participants | Patients With Stage 2 r-HAT |
|---|---|
| Percentage of Evaluable Patients With Stage 2 r-HAT, Whose Treatment Outcome is a Failure at the End of Hospitalization | 0 (0 to 8.43) |
Treatment outcome at test of cure (Month 12) is categorized as success or failure. Failure is defined as any of the following: presence of trypanosomes in any body fluid, death related to r-HAT or fexinidazole according to the DSMB, absence of clinical improvement leading to the use of rescue medication, or WBC count in the CSF \>20 cells/μL which was unlikely due to causes other than HAT. Unrelated deaths are neither success nor failure (the patient is considered non-evaluable for efficacy purposes).
| percentage of participants | Patients With Stage 2 r-HAT |
|---|---|
| Percentage of Evaluable Patients With Stage 2 r-HAT, Whose Treatment Outcome is a Failure at 12 Months | 2.94 (0.15 to 13.21) |
Treatment outcome at end of hospitalization (Day 12-18) is categorized as success or failure. Failure is defined as any of the following: presence of trypanosomes in any body fluid at end of treatment (Day 11), death related to r-HAT or fexinidazole at end of hospitalization according to the DSMB, or absence of clinical improvement leading to the use of rescue medication. Unrelated deaths are neither success nor failure (the patient is considered non-evaluable for efficacy purposes).
| percentage of participants | Patients With Stage 1 r-HAT |
|---|---|
| Percentage of Evaluable Patients With Stage 1 r-HAT, Whose Treatment Outcome is a Failure at the End of Hospitalization | 0 |
Treatment outcome at test of cure (Month 12) is categorized as success or failure. Failure is defined as any of the following: presence of trypanosomes in any body fluid, death related to r-HAT or fexinidazole according to the DSMB, absence of clinical improvement leading to the use of rescue medication, or WBC count in the CSF \>20 cells/μL which was unlikely due to causes other than HAT. Unrelated deaths are neither success nor failure (the patient is considered non-evaluable for efficacy purposes).
| percentage of participants | Patients With Stage 1 r-HAT |
|---|---|
| Percentage of Evaluable Patients With Stage 1 r-HAT, Whose Treatment Outcome is a Failure at 12 Months | 0 |
The percentage of patients who died between the first intake of fexinidazole until the End-of-Hospitalization Visit (Day 12-18), considering only deaths possibly related to r-HAT or study treatment as assessed by the DSMB, was calculated. The WHO verbal autopsy questionnaire was used since anatomopathological techniques were not available at the study sites (unless the death occurred at the hospital, in which case the investigator was present). In case of death that was not related to r-HAT nor to the study treatment during the hospitalization, the patient is considered as non-evaluable for efficacy purposes. Any patient who left the hospital without being medically discharged by the site Investigator before the planned End-of-Hospitalization Visit, and for whom no outcome could be retrieved, is also to be considered as non-evaluable.
| percentage of participants | Patients With Any r-HAT Stage |
|---|---|
| Percentage of Evaluable Patients With Any r-HAT Stage Who Died by the End of Hospitalization, Considering Only Deaths Possibly Related to r-HAT or Fexinidazole | 0 (0 to 6.58) |
Treatment outcome at end of hospitalization (Day 12-18) is categorized as success or failure. Failure is defined as any of the following: presence of trypanosomes in any body fluid at end of treatment (Day 11), death related to r-HAT or fexinidazole at end of hospitalization according to the DSMB, or absence of clinical improvement leading to the use of rescue medication. Unrelated deaths are neither success nor failure (the patient is considered non-evaluable for efficacy purposes).
| percentage of participants | Patients With Any r-HAT Stage |
|---|---|
| Percentage of Evaluable Patients With Any r-HAT Stage, Whose Treatment Outcome is a Failure at the End of Hospitalization | 0 (0 to 6.58) |
Treatment outcome at test of cure (Month 12) is categorized as success or failure. Failure is defined as any of the following: presence of trypanosomes in any body fluid, death related to r-HAT or fexinidazole according to the DSMB, absence of clinical improvement leading to the use of rescue medication, or WBC count in the CSF \>20 cells/μL which was unlikely due to causes other than HAT. Unrelated deaths are neither success nor failure (the patient is considered non-evaluable for efficacy purposes).
| percentage of participants | Patients With Any r-HAT Stage |
|---|---|
| Percentage of Evaluable Patients With Any r-HAT Stage, Whose Treatment Outcome is a Failure at 12 Months | 2.27 (0.12 to 10.34) |
Treatment-emergent AEs during the observation period were recorded from the first intake of fexinidazole (Day 1) until the End-of-Hospitalization Visit (between Day 12 and Day 18).
| Participants | Patients With Any r-HAT Stage |
|---|---|
| Number of Participants With Any AE (Including Abnormal Laboratory or ECG Finding if Considered Clinically Significant) Until the End of Hospitalization | 22 |
Treatment-emergent AEs considered as serious were collected from the first intake of fexinidazole (Day 1) until the End-of-Study Visit (Month 12). An AE was considered as serious if resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability or incapacity, was a congenital anomaly or birth defect, or was an important medical event.
| Participants | Patients With Any r-HAT Stage |
|---|---|
| Number of Participants With Any AE Considered as Serious Until the End of the Follow-up Period | 3 |
Treatment-emergent AEs considered as possibly related to fexinidazole were collected from the first intake of fexinidazole (Day 1) until the End-of-Study Visit (Month 12).
| Participants | Patients With Any r-HAT Stage |
|---|---|
| Number of Participants With Any AE Considered as Possibly Related to Fexinidazole Until the End of the Follow-up Period | 5 |
Collected over Non-serious treatment-emergent adverse events (AEs) were recorded from the first intake of fexinidazole (Day 1) until the End-of-Hospitalization Visit (Day 12-18). Treatment-emergent AEs considered as serious or related to fexinidazole treatment were collected from the first intake of fexinidazole (Day 1) until the End-of-Study Visit (Month 12). The population of analysis includes all patients who received at least one dose of fexinidazole.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patients With Stage 1 r-HAT | 0/10 (0%) | 0/10 (0%) | 6/10 (60%) |
| Patients With Stage 2 r-HAT | 1/35 (2.9%) | 3/35 (8.6%) | 16/35 (45.7%) |
| Event | Patients With Stage 1 r-HAT | Patients With Stage 2 r-HAT |
|---|---|---|
| Acute kidney injuryRenal and urinary disorders | 0/10 | 1/35 |
| PneumoniaInfections and infestations | 0/10 | 1/35 |
| Urinary tract infectionInfections and infestations | 0/10 | 1/35 |
| Event | Patients With Stage 1 r-HAT | Patients With Stage 2 r-HAT |
|---|---|---|
| HypertensionVascular disorders | 2/10 | 1/35 |
| VomitingGastrointestinal disorders | 1/10 | 5/35 |
| GastritisGastrointestinal disorders | 1/10 | 0/35 |
| Electrocardiogram U-wave abnormalityInvestigations | 1/10 | 2/35 |
| Haemoglobin decreasedInvestigations | 1/10 | 0/35 |
| HypoalbuminaemiaMetabolism and nutrition disorders | 1/10 | 2/35 |
| MalariaInfections and infestations | 1/10 | 1/35 |
| AnaemiaBlood and lymphatic system disorders | 1/10 | 0/35 |
| ChromaturiaRenal and urinary disorders | 1/10 | 0/35 |
| Neck painMusculoskeletal and connective tissue disorders | 1/10 | 0/35 |
All patients who took at least one dose of fexinidazole
| Age, Continuous(years) | Patients With Stage 1 r-HAT | Patients With Stage 2 r-HAT | Total |
|---|---|---|---|
| Mean | 33.2 ± 18.3 | 25.2 ± 15.2 | 27.0 ± 16.1 |
| Sex: Female, Male(Participants) | Patients With Stage 1 r-HAT | Patients With Stage 2 r-HAT | Total |
|---|---|---|---|
| Female | 1 | 13 | 14 |
| Male | 9 | 22 | 31 |
| Race/Ethnicity, Customized(Participants) | Patients With Stage 1 r-HAT | Patients With Stage 2 r-HAT | Total |
|---|---|---|---|
| Sub-Saharan African | 10 | 35 | 45 |
| Region of Enrollment(Participants) | Patients With Stage 1 r-HAT | Patients With Stage 2 r-HAT | Total |
|---|---|---|---|
| Malawi | 9 | 34 | 43 |
| Uganda | 1 | 1 | 2 |
| r-HAT stage: Stage 1, Stage 2(Participants) | Patients With Stage 1 r-HAT | Patients With Stage 2 r-HAT | Total |
|---|---|---|---|
| Stage 1 | 10 | 0 | 10 |
| Stage 2 | 0 | 35 | 35 |
| White blood cells (WBC) in cerebrospinal fluid (CSF)(cells/µL) | Patients With Stage 1 r-HAT | Patients With Stage 2 r-HAT | Total |
|---|---|---|---|
| Mean | 1.7 ± 1.6 | 79.3 ± 103.2 | 62.1 ± 96.4 |
PDFs hosted by the registry, ClinicalTrials.gov.
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Studies of the drug tested here: Fexinidazole
Drugs for Neglected Diseases