NCT02169557

Brief Summary

The purpose of this study is to demonstrate the treatment success of fexinidazole, at one year follow-up visit, in HAT stage 1 and early stage 2 patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
230

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 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

April 30, 2014

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

May 15, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 23, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 9, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2017

Completed
Last Updated

June 24, 2020

Status Verified

June 1, 2020

Enrollment Period

2.4 years

First QC Date

May 15, 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) visit 12 months after the end of treatment (EOT).

    12 months after end of treatment (day 11)

Secondary Outcomes (1)

  • Success or failure at each visit between the End of treatment and 18 months visit.

    End of treatment (day 11) to last follow-up visit (18 months)

Other Outcomes (1)

  • Safety

    From signature of informed consent to 18 months Follow up visit

Study Arms (1)

Fexinidazole

EXPERIMENTAL
Drug: Fexinidazole

Interventions

FexinidazoleDRUG
Fexinidazole

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent
  • years old or more
  • Male or female
  • Ability to ingest at least one complete meal per day (or at least one Plumpy'Nut® sachet)
  • Karnofsky index \> 50
  • Presence of trypanosomes in blood or lymph
  • Absence of trypanosomes in CSF
  • Permanent address and ability to comply with the follow-up visit schedule
  • Patient agreeing to be hospitalized to receive the treatment

You may not qualify if:

  • Severely malnutrition, defined as BMI \< 16.
  • Inability to take oral medication.
  • Pregnancy or breastfeeding (a urine pregnancy test will be performed in all women of childbearing age within 24 h prior to treatment).
  • Clinically relevant medical condition other than HAT that, in the Investigator's opinion, may jeopardize patient safety or interfere with participation in the study, including but not limited to significant liver or cardiovascular disease, documented or suspected active infection (including AIDS), CNS trauma or seizure disorders, coma or altered consciousness.
  • Severely deteriorated general condition, e.g. cardiovascular shock, respiratory distress syndrome, 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 value, such as:
  • Alanine aminotransferase (ALAT) and/or aspartate aminotransferase (ASAT) \> 2 times ULN
  • Total bilirubin (TBIL) \> 1.5 times ULN
  • Severe leukopenia (\< 2000/mm3)
  • +5 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 Ku Mesu V, Mutombo Kalonji W, Bardonneau C, Valverde Mordt O, Ngolo Tete D, Blesson S, Simon F, Delhomme S, Bernhard S, Mahenzi Mbembo H, Mpia Moke C, Lumeya Vuvu S, Mudji E'kitiak J, Akwaso Masa F, Mukendi Ilunga M, Mpoyi Muamba Nzambi D, Mayala Malu T, Kapongo Tshilumbwa S, Botalema Bolengi F, Nkieri Matsho M, Lumbala C, Scherrer B, Strub-Wourgaft N, Tarral A. Oral fexinidazole for stage 1 or early stage 2 African Trypanosoma brucei gambiense trypanosomiasis: a prospective, multicentre, open-label, cohort study. Lancet Glob Health. 2021 Jul;9(7):e999-e1008. doi: 10.1016/S2214-109X(21)00208-4.

    PMID: 34143998DERIVED

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

May 15, 2014

First Posted

June 23, 2014

Study Start

April 30, 2014

Primary Completion

October 9, 2016

Study Completion

April 25, 2017

Last Updated

June 24, 2020

Record last verified: 2020-06

Locations

DE(1)