Trial · NCT01685827
Pivotal Study of Fexinidazole for Human African Trypanosomiasis in Stage 2
NCT01685827, Phase 2, Phase 3, Completed, Drugs for Neglected Diseases
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pivotal Study of Fexinidazole for Human African Trypanosomiasis in Stage 2. Trials, record NCT01685827. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01685827
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pivotal Study of Fexinidazole for Human African Trypanosomiasis in Stage 2
- NCT number
- NCT01685827
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 394 participants, actual
- Lead sponsor
- Drugs for Neglected Diseases
- Conditions
- Human African Trypanosomiasis (HAT), Sleeping Sickness
- Interventions
- Fexinidazole, Nifurtimox, Eflornithine
- First posted
- 2012-09-14
- Last updated
- 2018-02-20
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | success or failure at 18 months FU visit | 18 months after treatment | The primary endpoint is the outcome (success or failure) at the test of cure (ToC) visit 18 months after the end of treatment (EOT) adapted from WHO criteria. Success at 18 months is: * Either cure: * patient alive, * AND with no evidence of trypanosomes in any body fluid, * AND 20 or less WBC/µl CSF * Or Probable cure: * Patient with no parasitological evidence of relapse in blood and lymph * AND who refuses lumbar puncture OR whose CSF sample is haemorrhagic without trypanosomes * AND whose clinical condition is satisfactory (without clinical symptom or signs) OR whose clinical status is unlikely to be due to HAT |
| Secondary | Safety endpoint | 18 days - observation period | Occurrence of any grade (all grades combined) adverse events during the observation period (D1-18) including: * any worsening of clinical symptoms listed in the inclusion checklist of symptoms and signs, * laboratory abnormalities of grade ≥ 2 * Occurrence of grade ≥ 3 adverse events during the observation period * Occurrence of drug-related adverse events (grade ≥ 3 and any grade) during the observation period |
| Secondary | Safety endpoint | 24 months | Occurrence of any serious adverse events from first drug intake to the end of follow-up period (18 months), and from M18 to M24. |
| Secondary | Pharmacokinetics endpoint | from D8 to D12 after first dosing | Whole blood and CSF concentrations of fexinidazole, M1, M2 and PK parameters derived from a model of population PK data. |
| Secondary | QT evaluation | D0 - D4 - D10 | recording of triplicates ECG |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29113731 | 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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01685827
GET https://conductscience.org/api/trials/v1/NCT01685827/registered