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

Human African Trypanosomiasis (HAT) Clinical Trial

Official title:

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 Trial Details — Status: Completed

Administrative data

• NCT number: NCT02184689
• Other study ID #: DNDiHATFEX006
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: May 3, 2014
• Est. completion date: June 27, 2017

Study information

• Verified date: June 2020
• Source: Drugs for Neglected Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: June 27, 2017
• Est. primary completion date: December 14, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 14 Years

Eligibility

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

• 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

• ECG abnormalities assessed by a central cardiologist

• QTcF= 450 ms, as measured automatically (if first measurement is abnormal, a second assessment will be done at least 10-20 min later, with the patient in resting position).

• Patients not tested for malaria and/or not treated adequately for this infection

• Patients not treated adequately for soil transmitted helminthic diseases

Related Conditions & MeSH terms

• Human African Trypanosomiasis (HAT)
• Trypanosomiasis
• Trypanosomiasis, African

Intervention

Drug:
• fexinidazole

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Drugs for Neglected Diseases

Country where clinical trial is conducted

Congo, The Democratic Republic of the, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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