OXA002: Prospective Study on Efficacy and Safety of Acoziborole (SCYX-7158) in Patients Infected by Human African Trypanosomiasis Due to T.b. Gambiense
Study Details
Study Description
Brief 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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Acoziborole (SCYX-7158) Acoziborole (SCYX-7158), in 320-mg tablets, administered by the oral route to patients in the fasting state according to the following dosing regimen: 960 mg (3 tablets) in a single intake on Day 1. |
Drug: Acoziborole (SCYX-7158)
|
Outcome Measures
Primary Outcome Measures
- Success or failure for patients in late stage HAT [18 months follow up]
Success is defined as a cure, according to the criteria adapted from the World Health Organization(WHO)
Secondary Outcome Measures
- Success or failure for all stage HAT patients [6, 12 and 18 months follow up]
Success is defined as a cure, according to the criteria adapted from the WHO
- Time to Failure in Patients with Late-stage HAT [18 months follow up]
Time of the first objective evidence of failure.
- Occurence of adverse events [From day 1 until 6 months follow-up]
Occurrence of any Adverse Event, including an abnormal laboratory test result, during the observation period and until 6 month follow-up.
- Occurence of serious advers events [Between the day 1 and the end of the follow-up period (18 month)]
Occurrence of any serious adverse events during the observation period and until 18 month follow-up
- Pharmacokinetics measure [Days 1, 2, 3, 4, 5, 11, Month 3 and Month 6 follow up visits]
SCYX-7158 Area Under Curve in whole blood and in the Cerebrospinal fluid (CSF);
- Pharmacokinetics measure [Days 1, 2, 3, 4, 5, 11, Month 3 and Month 6 follow up visits]
SCYX-7158 concentration in whole blood and in the Cerebrospinal fluid;
- Electrocardiogram measure [Days 1, 2, 3, 4, 5 and 11]
PR interval
- Electrocardiogram measure [Days 1, 2, 3, 4, 5 and 11]
quantitative description of PR interval
- Electrocardiogram measure [Days 1, 2, 3, 4, 5 and 11]
quantitative description of RR interval
- Electrocardiogram measure [Days 1, 2, 3, 4, 5 and 11]
quantitative description of QRs interval
- Electrocardiogram measure [Days 1, 2, 3, 4, 5 and 11]
quantitative description of QTcF interval
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male or female patient
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15 years of age or older
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Signed informed consent form (as well as assent from illiterate and under-age patients, and those unable to give consent)
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Karnofsky Performance Status above 50
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Able to ingest oral tablets
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Having a permanent address or being traceable by other persons
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Able to comply with the schedule of follow-up visits and requirements of the study
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Agreement to be hospitalised in order to receive treatment
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For patients with late-stage HAT:
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Confirmation of g-HAT by detection of the parasite in the blood and/or the lymph and/or the CSF, at the investigational centre
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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:
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Confirmation of g-HAT by detection of the parasite in the blood and/or the lymph, at the investigational centre
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Absence of parasites in the CSF
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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:
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Severe malnourishment, defined as body-mass index (BMI) below 16
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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)
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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
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Severely deteriorated health status, e.g. due to cardiovascular shock, respiratory distress syndrome or end-stage disease
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Previously treated for HAT (except prior treatment with pentamidine)
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Prior enrolment in the study
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Foreseeable difficulty complying with follow-up, including migrant worker, refugee status, itinerant trader etc.
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Current alcohol abuse or drug addiction
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Not tested for malaria and/or not having received appropriate treatment for malaria
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Not having received appropriate treatment for soil-transmitted helminthiasis
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre de Traitement de NKara | Nkara | Bandundu | Congo, The Democratic Republic of the | |
| 2 | Centre de Traitement de Kimpese | Kimpese | Bas Congo | Congo, The Democratic Republic of the | |
| 3 | Hôpital Général de Référence de NGandajika | Gandajika | Kasai Oriental | Congo, The Democratic Republic of the | |
| 4 | Hôpital de Dipumba | Mbuji-Mayi | Kasai-Oriental | Congo, The Democratic Republic of the | |
| 5 | Hôpital secondaire de Katanda | Katanda | Kasaï-Oriental | Congo, The Democratic Republic of the | |
| 6 | Hopital General de réference de Bagata | Bagata | Kwilu | Congo, The Democratic Republic of the | |
| 7 | Hôpital Général de référence de Masi-Manimba | Masi-Manimba | Kwilu | Congo, The Democratic Republic of the | |
| 8 | Hôpital Généal de référence de Kwamouth | Kwamouth | Mai-Ndombe | Congo, The Democratic Republic of the | |
| 9 | Hopital Général de réference de Bandundu | Bandundu | Congo, The Democratic Republic of the | ||
| 10 | Hôpital de référence d'Isangi | Isangi | Congo, The Democratic Republic of the | ||
| 11 | Hôpital Général de Référence Roi Baudouin | Kinshasa | Congo, The Democratic Republic of the | ||
| 12 | Centre de Traitement de la THA de Dubreka | Dubréka | Dubreka | Guinea |
Sponsors and Collaborators
- Drugs for Neglected Diseases
Investigators
- Principal Investigator: Victor Kande Betu Kumeso, Dr, Ministère de la Santé
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DNDi-OXA-02-HAT