Trial · NCT03025789
Fexinidazole in Human African Trypanosomiasis Due to T.b. Gambiense at Any Stage
NCT03025789, Phase 3, Completed, Drugs for Neglected Diseases; results first posted 2024-06-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Fexinidazole in Human African Trypanosomiasis Due to T.b. Gambiense at Any Stage. Trials, record NCT03025789. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03025789
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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. Gambiense at Any Stage
- NCT number
- NCT03025789
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 174 participants, actual
- Lead sponsor
- Drugs for Neglected Diseases
- Conditions
- Trypanosomiasis, African, Sleeping Sickness, Trypanosomiasis; Gambian
- Interventions
- Fexinidazole
- First posted
- 2017-01-20
- Last updated
- 2025-01-08
- Results first posted
- 2024-06-07
- Limitations and caveats
There is an overlap between the safety profile of fexinidazole and the g-HAT symptoms, making the interpretation of the safety data (in particular the relationship with fexinidazole) difficult as this was a cohort study and not a comparative study.~Some study sites were involved in another clinical trial. A recruitment bias towards patients not filling the other trial's criteria (pregnant and breastfeeding women, children, and patients with Karnofsky score between 40 and 50) may have occurred.
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Whose Treatment Outcome at Month 18 is a Success | Between the first intake of fexinidazole (Day 1) and the end of the follow-up period (18 months) | Treatment outcome at Month 18 is categorized as success or failure. Success is defined as a cure, according to the criteria adapted from the World Health Organization (WHO) update of the methodological framework for clinical trials in Sept 2014 (WHO/HTM/NTD/IDM/2015.5). Failure is defined as a relapse, probable relapse, death, use of rescue medication, loss to follow-up, refusal of all post-treatment lumbar puncture, and, in the absence of lumbar puncture at the Month 18 visit, an unfavorable outcome earlier than Month 18, or signs and symptoms evoking a relapse at Month 18. Success rate at Month 18 is defined as the percentage of participants (regardless of g-HAT stage) whose treatment outcome is a success at Month 18. An estimate of the success rate at Month 18 and the 95% exact Clopper-Pearson confidence interval (CI) of the estimate are provided. |
| Secondary | Percentage of Participants Whose Treatment Outcome at Month 12 is a Success | Between the first intake of fexinidazole (Day 1) and the end of the follow-up period (18 months) | Treatment outcome at Month 12 is categorized as success or failure. Success is defined as a cure, according to the criteria adapted from the World Health Organization (WHO) update of the methodological framework for clinical trials in Sept 2014 (WHO/HTM/NTD/IDM/2015.5). Failure is defined as a relapse, probable relapse, death, use of rescue medication, loss to follow-up, refusal of all post-treatment lumbar puncture, and, in the absence of lumbar puncture at the Month 12 visit, an unfavorable outcome earlier than Month 12, or signs and symptoms evoking a relapse at Month 12 (data collected at Month 18 are considered, if available). Success rate at Month 12 is defined as the percentage of participants (regardless of g-HAT stage) whose treatment outcome is a success at Month 12. An estimate of the success rate at Month 12 and the 95% exact Clopper-Pearson confidence interval (CI) of the estimate are provided. |
| Secondary | Number of Participants With Any Grade ≥ 3 Treatment-emergent Adverse Events (AEs) Including Laboratory and Hematological Abnormalities (if Considered Clinically Significant) | Between the first intake of fexinidazole (Day 1) and the end of the observation period, or the end of the follow-up period (18 months) for non-serious AEs assessed as related to fexinidazole | AE severity is graded according to the National Cancer Institute (NCI) Common Toxicity Criteria for AEs (CTCAE), Version 4.03 and, for certain laboratory parameters, modified CTCAE is used. Grade ≥3 AEs include the following events: Grade 3 events (severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living), Grade 4 events (life-threatening consequences; urgent intervention indicated), and Grade 5 events (death related to AE). The observation period extends from the first intake of fexinidazole (Day 1) until the end-of-hospitalization visit (between Day 13 and Day 18) for inpatients and until the end-of-treatment visit (on Day 11) for outpatients. |
| Secondary | Number of Participants With Any Treatment-emergent Serious Adverse Event (SAE) | Between the first intake of fexinidazole (Day 1) and the end of the follow-up period (18 months) | An SAE was defined as any AE that: resulted in death; was life-threatening; required inpatient hospitalisation or prolongation of existing hospitalisation; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; was an important medical event that was not immediately life-threatening or did not result in death, but that jeopardised the patient's safety or required an intervention to prevent one of the outcomes above. Patients treated on an outpatient basis who required hospitalisation, for whatever reason, underwent the same procedures as patients initially treated in hospital, up to the end of the hospitalisation period. During this period, and up to Day 13 or Day 18, the reasons for hospitalisation were not to be considered to be SAEs solely based on the criterion of hospitalisation, but could be considered to be SAEs based on other criteria. |
| Secondary | Number of Participants With Any Temporary or Permanent Treatment Discontinuation (Inpatient or Outpatient) for Reasons Related to Safety | Between the first intake (Day 1) and last intake of fexinidazole (Day 10, or Day 11 if re-administration occurred) | Number of patients who prematurely discontinued treatment (temporarily or permanently) for reasons related to safety (including overdose). |
| Secondary | Number of Participants With Any Hospitalization for Reasons Related to Safety (Outpatients Only) | Between the first intake (Day 1) and last intake of fexinidazole (Day 10, or Day 11 if re-administration occurred) | Number of outpatients who are hospitalized for reasons related to safety (including overdose). An outpatient is considered as "hospitalized for reasons related to safety" if he/she is initially planned to be treated as an outpatient but experiences an AE during the treatment period (Day 1 to Day 10) and is hospitalized during the treatment period. |
| Secondary | Number of Participants With Any Permanent Treatment Discontinuation (Inpatient or Outpatient) for Reasons Related to Safety | Between the first intake (Day 1) and last intake of fexinidazole (Day 10, or Day 11 if re-administration occurred) | Number of patients who prematurely discontinued treatment permanently for reasons related to safety (including overdose). |
| Secondary | Number of Outpatients Who Were Compliant With the Full Course of the 10-day Treatment | Between the first intake (Day 1) and last intake of fexinidazole (Day 10, or Day 11 if re-administration occurred) | Number of outpatients who completed the full course of the 10-day treatment. Full completion can be either completing the 10-day treatment in the outpatient setting, or starting treatment as an outpatient but finishing treatment at the hospital, for those who have to be hospitalized (for any reason). At Day 11, the participant and/or caregiver have to present the treatment packaging they received at study inclusion, and the investigator has to record if the treatment calendar was fully completed or not. |
| Secondary | Number of Outpatients Who Were Compliant With the 10-day Treatment Posology, Including Taking the Correct Number of Tablets During the 2 Phases of Treatment and Taking Tablets All at Once Every Day, With Food and Without Any Interruption of Treatment | End-of-treatment visit (Day 11) | Number of patients whose response to the question "How did you take your treatment?" is correct, as determined by the study personnel leading the compliance interview at Day 11 (end-of-treatment visit). The expected answer for participants weighing 35 kg or more is: 2 phases. Day 1 to 4 = 3 tablets. Day 5 to 10 = 2 tablets. Tablets to be taken all at once during a meal. The expected answer for participants weighing less than 35 kg is: 2 phases. Day 1 to 4 = 2 tablets. Day 5 to 10 = 1 tablet. Tablets to be taken all at once during a meal. The answer is considered correct if the 4 key messages have been understood (treatment period composed of 2 phases, each with a different number of tablets to be taken; treatment to be taken for 10 days without interruption; tablets to be taken all at once every day; treatment to be taken during a meal) |
| Secondary | Feasibility of Self-management of Treatment Intake in Outpatients: Occurrence of Temporary Treatment Discontinuation | End-of-treatment visit (Day 11) | The occurrence of temporary treatment discontinuation is recorded at Day 11 (end-of-treatment visit) in the case report form by the study personnel (Section on feasibility, question "Was the treatment temporarily discontinued?). Occurrence is presented as the number of outpatients who temporarily discontinued their treatment. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Whose Treatment Outcome at Month 18 is a Success | Between the first intake of fexinidazole (Day 1) and the end of the follow-up period (18 months) | This population includes all patients in the mITT population (i.e. who received at least one table of fexinidazole), regardless of treatment setting (inpatients and outpatients). The efficacy of fexinidazole was not meant to be studied in inpatients and outpatients separately. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Whose Treatment Outcome at Month 12 is a Success | Between the first intake of fexinidazole (Day 1) and the end of the follow-up period (18 months) | This population includes all patients in the mITT population (i.e. who received at least one table of fexinidazole), regardless of treatment setting (inpatients and outpatients). The efficacy of fexinidazole was not meant to be studied in inpatients and outpatients separately. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Any Grade ≥ 3 Treatment-emergent Adverse Events (AEs) Including Laboratory and Hematological Abnormalities (if Considered Clinically Significant) | Between the first intake of fexinidazole (Day 1) and the end of the observation period, or the end of the follow-up period (18 months) for non-serious AEs assessed as related to fexinidazole | The mITT population included all participants who received at least one table of fexinidazole. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Any Treatment-emergent Serious Adverse Event (SAE) | Between the first intake of fexinidazole (Day 1) and the end of the follow-up period (18 months) | The mITT population included all participants who received at least one table of fexinidazole. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Any Temporary or Permanent Treatment Discontinuation (Inpatient or Outpatient) for Reasons Related to Safety | Between the first intake (Day 1) and last intake of fexinidazole (Day 10, or Day 11 if re-administration occurred) | The mITT population included all participants who received at least one table of fexinidazole. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Any Hospitalization for Reasons Related to Safety (Outpatients Only) | Between the first intake (Day 1) and last intake of fexinidazole (Day 10, or Day 11 if re-administration occurred) | All outpatients included in the mITT population (i.e. who received at least one table of fexinidazole). This outcome measure is only applicable to outpatients to investigate the proportion of outpatients who had to be hospitalized during treatment due to safety. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Any Permanent Treatment Discontinuation (Inpatient or Outpatient) for Reasons Related to Safety | Between the first intake (Day 1) and last intake of fexinidazole (Day 10, or Day 11 if re-administration occurred) | The mITT population included all participants who received at least one table of fexinidazole. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Outpatients Who Were Compliant With the Full Course of the 10-day Treatment | Between the first intake (Day 1) and last intake of fexinidazole (Day 10, or Day 11 if re-administration occurred) | All outpatients included in the mITT population (i.e. participants who received at least one tablet of fexinidazole). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Outpatients Who Were Compliant With the 10-day Treatment Posology, Including Taking the Correct Number of Tablets During the 2 Phases of Treatment and Taking Tablets All at Once Every Day, With Food and Without Any Interruption of Treatment | End-of-treatment visit (Day 11) | Three of the 38 outpatients included in the mITT population were hospitalized and completed treatment at the hospital. As a consequence, they did not fill out the compliance questionnaire designed for outpatients after treatment. Therefore, the total number of patients analyzed was 35 outpatients. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Feasibility of Self-management of Treatment Intake in Outpatients: Occurrence of Temporary Treatment Discontinuation | End-of-treatment visit (Day 11) | All outpatients included in the mITT population (i.e. who received at least one table of fexinidazole). | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Whose Treatment Outcome at Month 18 is a Success | All Treated Patients, Regardless of Treatment Setting | 93.1 | 95% Confidence Interval 88.3 to 96.4 | percentage of participants | |
| Percentage of Participants Whose Treatment Outcome at Month 12 is a Success | All Treated Patients, Regardless of Treatment Setting | 94.3 | 95% Confidence Interval 89.7 to 97.2 | percentage of participants | |
| Number of Participants With Any Grade ≥ 3 Treatment-emergent Adverse Events (AEs) Including Laboratory and Hematological Abnormalities (if Considered Clinically Significant) | Inpatients | 10 | Participants | ||
| Number of Participants With Any Grade ≥ 3 Treatment-emergent Adverse Events (AEs) Including Laboratory and Hematological Abnormalities (if Considered Clinically Significant) | Outpatients | 4 | Participants | ||
| Number of Participants With Any Treatment-emergent Serious Adverse Event (SAE) | Inpatients | 10 | Participants | ||
| Number of Participants With Any Treatment-emergent Serious Adverse Event (SAE) | Outpatients | 4 | Participants | ||
| Number of Participants With Any Temporary or Permanent Treatment Discontinuation (Inpatient or Outpatient) for Reasons Related to Safety | Inpatients | 4 | Participants | ||
| Number of Participants With Any Temporary or Permanent Treatment Discontinuation (Inpatient or Outpatient) for Reasons Related to Safety | Outpatients | 0 | Participants | ||
| Number of Participants With Any Hospitalization for Reasons Related to Safety (Outpatients Only) | Outpatients | 2 | Participants | ||
| Number of Participants With Any Permanent Treatment Discontinuation (Inpatient or Outpatient) for Reasons Related to Safety | Inpatients | 1 | Participants |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Inpatients | 136 | |
| Overall Study | STARTED | Outpatients | 38 | |
| Overall Study | COMPLETED | Inpatients | 129 | |
| Overall Study | COMPLETED | Outpatients | 35 | |
| Overall Study | NOT COMPLETED | Inpatients | 7 | |
| Overall Study | NOT COMPLETED | Outpatients | 3 |
Source ClinicalTrials.gov
Adverse events62
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 | Abdominal pain | Gastrointestinal disorders | Inpatients | 6 | 136 | 6 |
| other | Abdominal pain | Gastrointestinal disorders | Outpatients | 2 | 38 | 2 |
| other | Abdominal pain upper | Gastrointestinal disorders | Inpatients | 5 | 136 | 6 |
| other | Abdominal pain upper | Gastrointestinal disorders | Outpatients | 2 | 38 | 2 |
| other | Dyspepsia | Gastrointestinal disorders | Inpatients | 6 | 136 | 6 |
| other | Dyspepsia | Gastrointestinal disorders | Outpatients | 2 | 38 | 2 |
| other | Nausea | Gastrointestinal disorders | Inpatients | 20 | 136 | 24 |
| other | Nausea | Gastrointestinal disorders | Outpatients | 7 | 38 | 7 |
| other | Salivary hypersecretion | Gastrointestinal disorders | Inpatients | 4 | 136 | 4 |
| other | Salivary hypersecretion | Gastrointestinal disorders | Outpatients | 2 | 38 | 2 |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Inpatients | 1 | 136 |
| Total, all-cause mortality | Outpatients | 0 | 38 |
| Total, other adverse events | Inpatients | 73 | 136 |
| Total, other adverse events | Outpatients | 23 | 38 |
| Total, serious adverse events | Inpatients | 10 | 136 |
| Total, serious adverse events | Outpatients | 4 | 38 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40288399 | 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 comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Inpatients vs Outpatients: Number of Participants With Any Temporary or Permanent Treatment Discontinuation (Inpatient or Outpatient) for Reasons Related to Safety | Trial comparisons |
| Inpatients vs Outpatients: Number of Participants With Any Treatment-emergent Serious Adverse Event (SAE) | Trial comparisons |
| Inpatients vs Outpatients: Number of Participants With Any Grade ≥ 3 Treatment-emergent Adverse Events (AEs) Including Laboratory and Hematological Abnormalities (if Considered Clinically Significant) | Trial comparisons |
| Inpatients vs Outpatients: Number of Participants With Any Permanent Treatment Discontinuation (Inpatient or Outpatient) for Reasons Related to Safety | Trial comparisons |
| Inpatients vs Outpatients: deaths from any cause | Trial comparisons |
| Inpatients vs Outpatients: 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.
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