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

Brief Title

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

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

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
    


Study Phase

Phase 2/Phase 3

Study Type

Interventional


Primary Outcome

Success or failure for patients in late stage HAT

Secondary Outcome

 Success or failure for all stage HAT patients

Condition

Trypanosomiasis, African

Intervention

Acoziborole (SCYX-7158)

Study Arms / Comparison Groups

 Acoziborole (SCYX-7158)
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

260

Start Date

October 11, 2016

Completion Date

August 28, 2020

Primary Completion Date

August 28, 2020

Eligibility Criteria

        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
      

Gender

All

Ages

15 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Victor Kande Betu Kumeso, Dr, , 

Location Countries

Congo, The Democratic Republic of the

Location Countries

Congo, The Democratic Republic of the

Administrative Informations


NCT ID

NCT03087955

Organization ID

DNDi-OXA-02-HAT


Responsible Party

Sponsor

Study Sponsor

Drugs for Neglected Diseases


Study Sponsor

Victor Kande Betu Kumeso, Dr, Principal Investigator, Ministère de la Santé


Verification Date

January 2022