Phase 3 N=45 Treatment

Fexinidazole in Human African Trypanosomiasis Due to T. b. Rhodesiense

Trypanosomiasis, African · Sleeping Sickness · Trypanosoma Brucei Rhodesiense; Infection

Bottom Line

View on ClinicalTrials.gov: NCT03974178 ↗

Enrolled (actual)

Serious AEs

6.7%

Results posted

Jan 2025

Primary outcome: 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 percentage of participants — p=0.0488

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Fexinidazole (Drug)
Age: Pediatric, Adult, Older Adult · 6+ yrs
Sex: All
Sponsor: Drugs for Neglected Diseases
Primary completion: Nov 2021

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	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03974178). 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.