NCT02184689

Brief Summary

The aim of the study is to assess the efficacy and safety of an oral regimen of fexinidazole (once daily for 10 days) in the treatment of stage 1 and stage 2 T.b. gambiense sleeping sickness in children at least 6 years old and over 20 kg bodyweight.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2014

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 3, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2014

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 9, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2017

Completed
Last Updated

June 24, 2020

Status Verified

June 1, 2020

Enrollment Period

2.6 years

First QC Date

June 19, 2014

Last Update Submit

June 23, 2020

Conditions

Human African Trypanosomiasis (HAT)

Outcome Measures

Primary Outcomes (1)

  • Outcome (success or failure) at the test of cure (ToC)

    Success at 12 months, adapted from the WHO criteria (51), is defined as a cured patient: * Patient alive; * AND no evidence of trypanosomes in any body fluid; * AND WBC ≤20/µL in CSF.

    12 months after the end of treatment

Study Arms (1)

Fexinidazole

EXPERIMENTAL
Drug: fexinidazole

Interventions

fexinidazoleDRUG
Fexinidazole

Eligibility Criteria

Age6 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Informed consent form signed by one of the parents or the child's legal representative
  • Child assent to participate in the study collected in the presence of an impartial witness
  • Age between 6 and 15 years old
  • \> 20 Kg bodyweight
  • Boy or girl
  • Able to ingest at least one complete meal per day (or at least one Plumpy'Nut® sachet)
  • Able to swallow 600mg fexinidazole tablets
  • Karnofsky index \> 50
  • Presence of trypanosomes in blood and/or lymph and/or CSF
  • Permanent address and ability to comply with follow-up visit schedule

You may not qualify if:

  • Child refusing to be included in the trial
  • Bodyweight \< 20 Kg
  • Severe malnutrition, defined as having a BMI below 16 (- 2 Z-score of the norm according to WHO 2007 Growth reference data)
  • Inability to take oral medication
  • Pregnancy or breastfeeding
  • Clinically relevant medical condition other than HAT that, in the Investigator's opinion, may jeopardize subject safety or interfere with participation in the study, including but not limited to significant liver or cardiovascular disease, active documented or suspected infection, central nervous system (CNS) trauma or seizure disorders, coma or altered consciousness
  • Severely deteriorated general condition, such as cardiovascular shock, respiratory distress, or terminal illness
  • Any medical condition (except HAT-specific symptoms) hindering communication with the Investigator as required for the completion of this study
  • Any contraindication to imidazole products (known hypersensitivity to imidazoles)
  • History of HAT treatment in the past 2 years
  • Patients previously enrolled in the study or having already received fexinidazole.
  • Expected follow-up difficulties (migrants, refugees, itinerant vendors, etc.).
  • Current alcohol or drug abuse
  • Clinically significant abnormal laboratory findings, including ASAT and/or ALAT \> 2 times ULN // Total bilirubin \> 1.5 times ULN // Severe leukopenia (\< 2000/mm3) // Potassium (K+) \< 3.5 mmol // Any other clinically significant abnormal laboratory value (see details in Investigator Manual)
  • Pregnancy confirmed by a positive urine pregnancy test obtained within 24 hours (h) prior to start of study treatment (see Section 5.8.3 Contraception; p36) for girls over 12 years old and over
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Kinshasa, Democratic Republic of the Congo

Location

Related Publications (1)

  • Kande Betu Kumesu V, Mutombo Kalonji W, Bardonneau C, Valverde Mordt O, Ngolo Tete D, Blesson S, Simon F, Delhomme S, Bernhard S, Nganzobo Ngima P, Mahenzi Mbembo H, Fina Lubaki JP, Lumeya Vuvu S, Kuziena Mindele W, Ilunga Wa Kyhi M, Mandula Mokenge G, Kaninda Badibabi L, Kasongo Bonama A, Kavunga Lukula P, Lumbala C, Scherrer B, Strub-Wourgaft N, Tarral A. Safety and efficacy of oral fexinidazole in children with gambiense human African trypanosomiasis: a multicentre, single-arm, open-label, phase 2-3 trial. Lancet Glob Health. 2022 Nov;10(11):e1665-e1674. doi: 10.1016/S2214-109X(22)00338-2. Epub 2022 Sep 27.

    PMID: 36179736DERIVED

MeSH Terms

Interventions

fexinidazole

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2014

First Posted

July 9, 2014

Study Start

May 3, 2014

Primary Completion

December 14, 2016

Study Completion

June 27, 2017

Last Updated

June 24, 2020

Record last verified: 2020-06

Locations

DE(1)