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Efficacy and Safety of Fexinidazole in Children at Least 6 Years Old and Weighing Over 20 kg With Human African Trypanosomiasis (HAT) Due to T.b. Gambiense: a Prospective, Multicentre, Open Study, plug-in to the Pivotal Study | Clinical Trials | Clareo Health

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Efficacy and Safety of Fexinidazole in Children at Least 6 Years Old and Weighing Over 20 kg With Human African Trypanosomiasis (HAT) Due to T.b. Gambiense: a Prospective, Multicentre, Open Study, plug-in to the Pivotal Study

NCT02184689•Drugs for Neglected Diseases

View on ClinicalTrials.gov

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.

Eligibility

Age

6 - 14 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

Exclusion Criteria

•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
+9 more criteria

Locations (1)

Kinshasa, Democratic Republic of the Congo

Key Dates

Start Date

May 3, 2014

Primary Completion Date

December 14, 2016

Completion Date

June 27, 2017

Last Updated

June 24, 2020

Enrollment

125

ACTUAL participants

Conditions

Human African Trypanosomiasis (HAT)

Interventions

fexinidazole

DRUG