Phase 3
Completed N=45
Fexinidazole in Human African Trypanosomiasis Due to T. b. Rhodesiense
Trypanosomiasis, African · Sleeping Sickness · Trypanosoma Brucei Rhodesiense; Infection
Source: ClinicalTrials.gov NCT03974178 ↗
Enrolled (actual)
45
Serious AEs
6.7%
Results posted
Jan 2025
Primary outcomePrimary: 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 percentage of participants — p=0.0488
◆ Published Evidence
Emerging
10citations · ~10 / year
Fexinidazole as a new oral treatment for human African trypanosomiasis due to Trypanosoma brucei rhodesiense: a prospective, open-label, single-arm, phase 2-3, non-randomised study.
Summary
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:
* Is the short-term fatality rate and failure rate associated with fexinidazole lower than those of melarsoprol in patients with stage 2 r-HAT?
* Is the long-term failure rate associated with fexinidazole lower than that of melarsoprol in patients with stage 2 r-HAT?
* Can fexinidazole in patients with stage 1 r-HAT replace the treatment with suramin?
* Is fexinidazole treatment safe in patient with r-HAT, regardless of stage?
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.
Linked Publications
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Fexinidazole as a new oral treatment for human African trypanosomiasis due to Trypanosoma brucei rhodesiense: a prospective, open-label, single-arm, phase 2-3, non-randomised study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
— | 0.0488 sig |
| SECONDARY Percentage of Evaluable Patients With Stage 2 r-HAT, Whose Treatment Outcome is a Failure at the End of Hospitalization |
— | 0.0405 sig |
| SECONDARY Percentage of Evaluable Patients With Stage 2 r-HAT, Whose Treatment Outcome is a Failure at 12 Months |
2.94 | 0.0730 |
| SECONDARY Percentage of Evaluable Patients With Stage 1 r-HAT, Whose Treatment Outcome is a Failure at the End of Hospitalization |
— | — |
| SECONDARY Percentage of Evaluable Patients With Stage 1 r-HAT, Whose Treatment Outcome is a Failure at 12 Months |
— | — |
| SECONDARY 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 |
— | 0.0201 sig |
| SECONDARY Percentage of Evaluable Patients With Any r-HAT Stage, Whose Treatment Outcome is a Failure at the End of Hospitalization |
— | 0.0158 sig |
| SECONDARY Percentage of Evaluable Patients With Any r-HAT Stage, Whose Treatment Outcome is a Failure at 12 Months |
2.27 | 0.0253 sig |
| SECONDARY Number of Participants With Any AE (Including Abnormal Laboratory or ECG Finding if Considered Clinically Significant) Until the End of Hospitalization |
22 | — |
| SECONDARY Number of Participants With Any AE Considered as Serious Until the End of the Follow-up Period |
3 | — |
| SECONDARY Number of Participants With Any AE Considered as Possibly Related to Fexinidazole Until the End of the Follow-up Period |
5 | — |
Eligibility Criteria
Inclusion Criteria
- Signed Informed Consent Form (plus assent for children)
- ≥ 6 years old
- ≥ 20 kg body weight
- Ability to ingest at least one complete meal per day (or at least one Plumpy'Nut® sachet)
- Karnofsky index ≥ 40
- Parasitological confirmation of T. b. rhodesiense infection
- Having a permanent address or being traceable by others and willing and able to comply with follow-up visit schedule
- Agreement to be hospitalised for a minimum of 13 days and to receive the study treatment
Exclusion Criteria
- Active clinically relevant medical conditions other than HAT that may jeopardize subject safety or at the investigator discretion may interfere with participation in the study.
- Compromised general health or severely deteriorated general condition, such as severe malnutrition, cardiovascular shock, respiratory distress, or terminal illness
- Patients with severe hepatic impairment (e.g.: clinical signs of cirrhosis or jaundice)
- Known hypersensitivity to fexinidazole, to any nitroimidazole drugs (e.g. metronidazole, tinidazole), or to any of the excipients
- Patients previously enrolled in the study or having already received fexinidazole
Data sourced from ClinicalTrials.gov (NCT03974178) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.