Trial · NCT03974178
Fexinidazole in Human African Trypanosomiasis Due to T. b. Rhodesiense
NCT03974178, Phase 2, Phase 3, Completed, Drugs for Neglected Diseases; results first posted 2025-01-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Fexinidazole in Human African Trypanosomiasis Due to T. b. Rhodesiense. Trials, record NCT03974178. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03974178
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Fexinidazole in Human African Trypanosomiasis Due to T. b. Rhodesiense
- NCT number
- NCT03974178
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 45 participants, actual
- Lead sponsor
- Drugs for Neglected Diseases
- Conditions
- Trypanosomiasis, African, Sleeping Sickness, Trypanosoma Brucei Rhodesiense; Infection
- Interventions
- Fexinidazole
- First posted
- 2019-06-04
- Last updated
- 2025-01-30
- Results first posted
- 2025-01-30
- Limitations and caveats
The main limitation is the benchmark study design. A direct comparison with melarsoprol was impossible due to its toxicity (5% of patients die due to treatment-related encephalopathy) and the rarity of r-HAT cases. The annual number of r-HAT cases in all endemic countries decreased from 110 patients in 2012 to 27 in 2017. Although the primary endpoint required a subjective assessment of the cause of death, this was performed by independent experts from the safety committee to ensure robustness.
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | 12 to 18 days after start of treatment | 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. |
| Secondary | Percentage of Evaluable Patients With Stage 2 r-HAT, Whose Treatment Outcome is a Failure at the End of Hospitalization | 12 to 18 days after start of treatment | 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). |
| Secondary | Percentage of Evaluable Patients With Stage 2 r-HAT, Whose Treatment Outcome is a Failure at 12 Months | 12 months after start of treatment | 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). |
| Secondary | Percentage of Evaluable Patients With Stage 1 r-HAT, Whose Treatment Outcome is a Failure at the End of Hospitalization | 12 to 18 days after start of treatment | 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). |
| Secondary | Percentage of Evaluable Patients With Stage 1 r-HAT, Whose Treatment Outcome is a Failure at 12 Months | 12 months after start of treatment | 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). |
| 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 | 12 to 18 days after start of treatment | 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. |
| Secondary | Percentage of Evaluable Patients With Any r-HAT Stage, Whose Treatment Outcome is a Failure at the End of Hospitalization | 12 to 18 days after start of treatment | 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). |
| Secondary | Percentage of Evaluable Patients With Any r-HAT Stage, Whose Treatment Outcome is a Failure at 12 Months | 12 months after start of treatment | 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). |
| Secondary | Number of Participants With Any AE (Including Abnormal Laboratory or ECG Finding if Considered Clinically Significant) Until the End of Hospitalization | 12 to 18 days (between Day 1 and Day 12-18) | 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). |
| Secondary | Number of Participants With Any AE Considered as Serious Until the End of the Follow-up Period | 12 months (between Day 1 and Month 12) | 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. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 | 12 to 18 days after start of treatment | The analysis is performed in evaluable patients with stage 2 r-HAT. A total of 35 patients with stage 2 r-HAT were enrolled and treated. One patient died during hospitalization, but the death was considered unrelated to r-HAT and/or the study treatment, as evaluated by the Investigator and the DSMB and accepted by the Sponsor. As per protocol, this patient was considered non-evaluable for efficacy purposes. There were 34 patients with stage 2 r-HAT who were evaluable. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Evaluable Patients With Stage 2 r-HAT, Whose Treatment Outcome is a Failure at the End of Hospitalization | 12 to 18 days after start of treatment | The analysis is performed in evaluable patients with stage 2 r-HAT. A total of 35 patients with stage 2 r-HAT were enrolled and treated. One patient died during hospitalization, but the death was considered unrelated to r-HAT and/or the study treatment, as evaluated by the Investigator and the DSMB and accepted by the Sponsor. As per protocol, this patient was considered non-evaluable for efficacy purposes. There were 34 patients with stage 2 r-HAT who were evaluable. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Evaluable Patients With Stage 2 r-HAT, Whose Treatment Outcome is a Failure at 12 Months | 12 months after start of treatment | The analysis is performed in evaluable patients with stage 2 r-HAT. A total of 35 patients with stage 2 r-HAT were enrolled and treated. One patient died during hospitalization, but the death was considered unrelated to r-HAT and/or the study treatment, as evaluated by the Investigator and the DSMB and accepted by the Sponsor. As per protocol, this patient was considered non-evaluable for efficacy purposes. There were 34 patients with stage 2 r-HAT who were evaluable. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Evaluable Patients With Stage 1 r-HAT, Whose Treatment Outcome is a Failure at the End of Hospitalization | 12 to 18 days after start of treatment | The analysis is performed in evaluable patients with stage 1 r-HAT. None of patients with stage 1 r-HAT died from causes related to r-HAT or study treatment; therefore, all 10 patients were evaluable. Because the number of patients with stage 1 r-HAT is very small, no null hypotheses are testable and only descriptive data are provided. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Evaluable Patients With Stage 1 r-HAT, Whose Treatment Outcome is a Failure at 12 Months | 12 months after start of treatment | The analysis is performed in evaluable patients with stage 1 r-HAT. None of patients with stage 1 r-HAT died from causes related to r-HAT or study treatment; therefore, all 10 patients were evaluable. Because the number of patients with stage 1 r-HAT is very small, no null hypotheses are testable and only descriptive data are provided. | percentage of participants | NUMBER |
| 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 | 12 to 18 days after start of treatment | The analysis is performed in evaluable patients with any r-HAT stage. A total of 45 patients were enrolled and treated. One patient died during hospitalization, but the death was considered unrelated to r-HAT and/or the study treatment, as evaluated by the Investigator and the DSMB and accepted by the Sponsor. As per protocol, this patient was considered non-evaluable for efficacy purposes. There were 44 patients who were evaluable. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Evaluable Patients With Any r-HAT Stage, Whose Treatment Outcome is a Failure at the End of Hospitalization | 12 to 18 days after start of treatment | The analysis is performed in evaluable patients with any r-HAT stage. A total of 45 patients were enrolled and treated. One patient died during hospitalization, but the death was considered unrelated to r-HAT and/or the study treatment, as evaluated by the Investigator and the DSMB and accepted by the Sponsor. As per protocol, this patient was considered non-evaluable for efficacy purposes. There were 44 patients who were evaluable. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Evaluable Patients With Any r-HAT Stage, Whose Treatment Outcome is a Failure at 12 Months | 12 months after start of treatment | The analysis is performed in evaluable patients with any r-HAT stage. A total of 45 patients were enrolled and treated. One patient died during hospitalization, but the death was considered unrelated to r-HAT and/or the study treatment, as evaluated by the Investigator and the DSMB and accepted by the Sponsor. As per protocol, this patient was considered non-evaluable for efficacy purposes. There were 44 patients who were evaluable. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Any AE (Including Abnormal Laboratory or ECG Finding if Considered Clinically Significant) Until the End of Hospitalization | 12 to 18 days (between Day 1 and Day 12-18) | The analysis is performed in all patients who took at least one dose of fexinidazole (regardless of r-HAT stage). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Any AE Considered as Serious Until the End of the Follow-up Period | 12 months (between Day 1 and Month 12) | The analysis is performed in all patients who took at least one dose of fexinidazole (regardless of r-HAT stage). | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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 | Patients With Stage 2 r-HAT | 0 | 90% Confidence Interval 0 to 8.43 | percentage of participants | |
| Percentage of Evaluable Patients With Stage 2 r-HAT, Whose Treatment Outcome is a Failure at the End of Hospitalization | Patients With Stage 2 r-HAT | 0 | 90% Confidence Interval 0 to 8.43 | percentage of participants | |
| Percentage of Evaluable Patients With Stage 2 r-HAT, Whose Treatment Outcome is a Failure at 12 Months | Patients With Stage 2 r-HAT | 2.94 | 90% Confidence Interval 0.15 to 13.21 | percentage of participants | |
| Percentage of Evaluable Patients With Stage 1 r-HAT, Whose Treatment Outcome is a Failure at the End of Hospitalization | Patients With Stage 1 r-HAT | 0 | percentage of participants | ||
| Percentage of Evaluable Patients With Stage 1 r-HAT, Whose Treatment Outcome is a Failure at 12 Months | Patients With Stage 1 r-HAT | 0 | percentage of participants | ||
| 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 | Patients With Any r-HAT Stage | 0 | 90% Confidence Interval 0 to 6.58 | percentage of participants | |
| Percentage of Evaluable Patients With Any r-HAT Stage, Whose Treatment Outcome is a Failure at the End of Hospitalization | Patients With Any r-HAT Stage | 0 | 90% Confidence Interval 0 to 6.58 | percentage of participants | |
| Percentage of Evaluable Patients With Any r-HAT Stage, Whose Treatment Outcome is a Failure at 12 Months | Patients With Any r-HAT Stage | 2.27 | 90% Confidence Interval 0.12 to 10.34 | percentage of participants | |
| Number of Participants With Any AE (Including Abnormal Laboratory or ECG Finding if Considered Clinically Significant) Until the End of Hospitalization | Patients With Any r-HAT Stage | 22 | Participants | ||
| Number of Participants With Any AE Considered as Serious Until the End of the Follow-up Period | Patients With Any r-HAT Stage | 3 | Participants |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Patients With Stage 1 r-HAT | 10 | |
| Overall Study | STARTED | Patients With Stage 2 r-HAT | 35 | |
| Overall Study | COMPLETED | Patients With Stage 1 r-HAT | 10 | |
| Overall Study | COMPLETED | Patients With Stage 2 r-HAT | 34 | |
| Overall Study | NOT COMPLETED | Patients With Stage 1 r-HAT | 0 | |
| Overall Study | NOT COMPLETED | Patients With Stage 2 r-HAT | 1 |
Source ClinicalTrials.gov
Adverse events54
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Vomiting | Gastrointestinal disorders | Patients With Stage 1 r-HAT | 1 | 10 | 1 |
| other | Vomiting | Gastrointestinal disorders | Patients With Stage 2 r-HAT | 5 | 35 | 5 |
| other | Nausea | Gastrointestinal disorders | Patients With Stage 1 r-HAT | 0 | 10 | 0 |
| other | Nausea | Gastrointestinal disorders | Patients With Stage 2 r-HAT | 2 | 35 | 2 |
| other | Dysphagia | Gastrointestinal disorders | Patients With Stage 1 r-HAT | 0 | 10 | 0 |
| other | Dysphagia | Gastrointestinal disorders | Patients With Stage 2 r-HAT | 1 | 35 | 1 |
| other | Gastritis | Gastrointestinal disorders | Patients With Stage 1 r-HAT | 1 | 10 | 1 |
| other | Gastritis | Gastrointestinal disorders | Patients With Stage 2 r-HAT | 0 | 35 | 0 |
| other | Electrocardiogram U-wave abnormality | Investigations | Patients With Stage 1 r-HAT | 1 | 10 | 1 |
| other | Electrocardiogram U-wave abnormality | Investigations | Patients With Stage 2 r-HAT | 2 | 35 | 3 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Patients With Stage 1 r-HAT | 0 | 10 |
| Total, all-cause mortality | Patients With Stage 2 r-HAT | 1 | 35 |
| Total, other adverse events | Patients With Stage 1 r-HAT | 6 | 10 |
| Total, other adverse events | Patients With Stage 2 r-HAT | 16 | 35 |
| Total, serious adverse events | Patients With Stage 1 r-HAT | 0 | 10 |
| Total, serious adverse events | Patients With Stage 2 r-HAT | 3 | 35 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40288400 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Patients With Stage 1 r-HAT vs Patients With Stage 2 r-HAT: deaths from any cause | Trial comparisons |
| Patients With Stage 1 r-HAT vs Patients With Stage 2 r-HAT: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03974178
GET https://conductscience.org/api/trials/v1/NCT03974178/events?page=2