Prospective Study on Efficacy and Safety of Acoziborole (SCYX-7158) in Patients Infected by Human African Trypanosomiasis Due to T.b. Gambiense

Trypanosomiasis, African Clinical Trial

— OXA002  

Official title:

Efficacy and Safety Study of Acoziborole (SCYX-7158) in Patients With Human African Trypanosomiasis (HAT) Due to Trypanosoma Brucei Gambiense: a Multicentre, Open-label, Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03087955
• Other study ID #: DNDi-OXA-02-HAT
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: October 11, 2016
• Est. completion date: August 28, 2020

Study information

• Verified date: January 2022
• Source: Drugs for Neglected Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this study is to assess efficacy and safety of Acoziborole (SCYX-7158) given as a single dose oral treatment for adult patients (above or equal 15) in the fasting state with T.b. Gambiense HAT

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: August 28, 2020
• Est. primary completion date: August 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• Male or female patient
• 15 years of age or older
• Signed informed consent form (as well as assent from illiterate and under-age patients, and those unable to give consent)
• Karnofsky Performance Status above 50
• Able to ingest oral tablets
• Having a permanent address or being traceable by other persons
• Able to comply with the schedule of follow-up visits and requirements of the study
• Agreement to be hospitalised in order to receive treatment
• For patients with late-stage HAT:
• Confirmation of g-HAT by detection of the parasite in the blood and/or the lymph and/or the CSF, at the investigational centre
• If trypanosomes are found in the blood or lymph, but not in the CSF, the CSF WBC, measured at the investigational centre, must be above 20/µL for the patient to be included in the cohort of patients with late-stage HAT
• For patients with early- or intermediate-stage HAT:
• Confirmation of g-HAT by detection of the parasite in the blood and/or the lymph, at the investigational centre
• Absence of parasites in the CSF
• The CSF WBC, measured at the investigational centre, must be between 6 and 20/µL for the patient to be included in the cohort of patients with intermediate-stage HAT and equal to or below 5/µL for the patient to be included in the cohort of patients with early-stage HAT.

Exclusion Criteria:

• Severe malnourishment, defined as body-mass index (BMI) below 16
• Pregnancy or breastfeeding (for women of child-bearing potential, confirmed pregnancy on a urine pregnancy test performed within 24 hours prior to administration of SCYX-7158)
• Clinically significant medical condition that could, in the opinion of the Investigator, jeopardise the patient's safety or interfere with participation in the study, including, but not limited to significant liver or cardiovascular disease, suspected or proven active infection, central nervous system trauma or seizure disorder, coma or consciousness disturbances
• Severely deteriorated health status, e.g. due to cardiovascular shock, respiratory distress syndrome or end-stage disease
• Previously treated for HAT (except prior treatment with pentamidine)
• Prior enrolment in the study
• Foreseeable difficulty complying with follow-up, including migrant worker, refugee status, itinerant trader etc.
• Current alcohol abuse or drug addiction
• Not tested for malaria and/or not having received appropriate treatment for malaria
• Not having received appropriate treatment for soil-transmitted helminthiasis
• Clinically significant abnormal laboratory values including Aspartate AminoTransferase(AST) and/or AlanineAminoTransferase (ALT) more than 2 times the upper limit of normal (ULN), total bilirubin more than 1.5 ULN, severe leukopenia at less than 2000/mm3, Potassium below 3.5 mmol/L, any other clinically significant abnormal laboratory value

Related Conditions & MeSH terms

• Gambiense Trypanosomiasis
• Sleeping Sickness
• Trypanosomiasis
• Trypanosomiasis, African

Intervention

Drug:
• Acoziborole (SCYX-7158)

Locations

Country	Name	City	State
Congo, The Democratic Republic of the	Hopital General de réference de Bagata	Bagata	Kwilu
Congo, The Democratic Republic of the	Hopital Général de réference de Bandundu	Bandundu
Congo, The Democratic Republic of the	Hôpital Général de Référence de NGandajika	Gandajika	Kasai Oriental
Congo, The Democratic Republic of the	Hôpital de référence d'Isangi	Isangi
Congo, The Democratic Republic of the	Hôpital secondaire de Katanda	Katanda	Kasaï-Oriental
Congo, The Democratic Republic of the	Centre de Traitement de Kimpese	Kimpese	Bas Congo
Congo, The Democratic Republic of the	Hôpital Général de Référence Roi Baudouin	Kinshasa
Congo, The Democratic Republic of the	Hôpital Généal de référence de Kwamouth	Kwamouth	Mai-Ndombe
Congo, The Democratic Republic of the	Hôpital Général de référence de Masi-Manimba	Masi-Manimba	Kwilu
Congo, The Democratic Republic of the	Hôpital de Dipumba	Mbuji-Mayi	Kasai-Oriental
Congo, The Democratic Republic of the	Centre de Traitement de NKara	Nkara	Bandundu
Guinea	Centre de Traitement de la THA de Dubreka	Dubréka	Dubreka

Sponsors (1)

Lead Sponsor	Collaborator
Drugs for Neglected Diseases

Countries where clinical trial is conducted

Congo, The Democratic Republic of the,  Guinea, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success or failure for patients in late stage HAT	Success is defined as a cure, according to the criteria adapted from the World Health Organization(WHO)	18 months follow up
Secondary	Success or failure for all stage HAT patients	Success is defined as a cure, according to the criteria adapted from the WHO	6, 12 and 18 months follow up
Secondary	Time to Failure in Patients with Late-stage HAT	Time of the first objective evidence of failure.	18 months follow up
Secondary	Occurence of adverse events	Occurrence of any Adverse Event, including an abnormal laboratory test result, during the observation period and until 6 month follow-up.	From day 1 until 6 months follow-up
Secondary	Occurence of serious advers events	Occurrence of any serious adverse events during the observation period and until 18 month follow-up	Between the day 1 and the end of the follow-up period (18 month)
Secondary	Pharmacokinetics measure	SCYX-7158 Area Under Curve in whole blood and in the Cerebrospinal fluid (CSF);	Days 1, 2, 3, 4, 5, 11, Month 3 and Month 6 follow up visits
Secondary	Pharmacokinetics measure	SCYX-7158 concentration in whole blood and in the Cerebrospinal fluid;	Days 1, 2, 3, 4, 5, 11, Month 3 and Month 6 follow up visits
Secondary	Electrocardiogram measure	PR interval	Days 1, 2, 3, 4, 5 and 11
Secondary	Electrocardiogram measure	quantitative description of PR interval	Days 1, 2, 3, 4, 5 and 11
Secondary	Electrocardiogram measure	quantitative description of RR interval	Days 1, 2, 3, 4, 5 and 11
Secondary	Electrocardiogram measure	quantitative description of QRs interval	Days 1, 2, 3, 4, 5 and 11
Secondary	Electrocardiogram measure	quantitative description of QTcF interval	Days 1, 2, 3, 4, 5 and 11