search
Back to results

Prospective Study on Efficacy and Safety of Acoziborole (SCYX-7158) in Patients Infected by Human African Trypanosomiasis Due to T.b. Gambiense (OXA002)

Primary Purpose

Trypanosomiasis, African, Gambiense Trypanosomiasis, Sleeping Sickness

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Acoziborole (SCYX-7158)
Sponsored by
Drugs for Neglected Diseases
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trypanosomiasis, African

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre de Traitement de NKara
  • Centre de Traitement de Kimpese
  • Hôpital Général de Référence de NGandajika
  • Hôpital de Dipumba
  • Hôpital secondaire de Katanda
  • Hopital General de réference de Bagata
  • Hôpital Général de référence de Masi-Manimba
  • Hôpital Généal de référence de Kwamouth
  • Hopital Général de réference de Bandundu
  • Hôpital de référence d'Isangi
  • Hôpital Général de Référence Roi Baudouin
  • Centre de Traitement de la THA de Dubreka

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Acoziborole (SCYX-7158)

Arm 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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Success or failure for all stage HAT patients
Success is defined as a cure, according to the criteria adapted from the WHO
Time to Failure in Patients with Late-stage HAT
Time of the first objective evidence of failure.
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.
Occurence of serious advers events
Occurrence of any serious adverse events during the observation period and until 18 month follow-up
Pharmacokinetics measure
SCYX-7158 Area Under Curve in whole blood and in the Cerebrospinal fluid (CSF);
Pharmacokinetics measure
SCYX-7158 concentration in whole blood and in the Cerebrospinal fluid;
Electrocardiogram measure
PR interval
Electrocardiogram measure
quantitative description of PR interval
Electrocardiogram measure
quantitative description of RR interval
Electrocardiogram measure
quantitative description of QRs interval
Electrocardiogram measure
quantitative description of QTcF interval

Full Information

First Posted
March 7, 2017
Last Updated
January 17, 2022
Sponsor
Drugs for Neglected Diseases
search

1. Study Identification

Unique Protocol Identification Number
NCT03087955
Brief Title
Prospective Study on Efficacy and Safety of Acoziborole (SCYX-7158) in Patients Infected by Human African Trypanosomiasis Due to T.b. Gambiense
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
October 11, 2016 (Actual)
Primary Completion Date
August 28, 2020 (Actual)
Study Completion Date
August 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Drugs for Neglected Diseases

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trypanosomiasis, African, Gambiense Trypanosomiasis, Sleeping Sickness

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
260 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victor Kande Betu Kumeso, Dr
Organizational Affiliation
Ministère de la Santé
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre de Traitement de NKara
City
Nkara
State/Province
Bandundu
Country
Congo, The Democratic Republic of the
Facility Name
Centre de Traitement de Kimpese
City
Kimpese
State/Province
Bas Congo
Country
Congo, The Democratic Republic of the
Facility Name
Hôpital Général de Référence de NGandajika
City
Gandajika
State/Province
Kasai Oriental
Country
Congo, The Democratic Republic of the
Facility Name
Hôpital de Dipumba
City
Mbuji-Mayi
State/Province
Kasai-Oriental
Country
Congo, The Democratic Republic of the
Facility Name
Hôpital secondaire de Katanda
City
Katanda
State/Province
Kasaï-Oriental
Country
Congo, The Democratic Republic of the
Facility Name
Hopital General de réference de Bagata
City
Bagata
State/Province
Kwilu
Country
Congo, The Democratic Republic of the
Facility Name
Hôpital Général de référence de Masi-Manimba
City
Masi-Manimba
State/Province
Kwilu
Country
Congo, The Democratic Republic of the
Facility Name
Hôpital Généal de référence de Kwamouth
City
Kwamouth
State/Province
Mai-Ndombe
Country
Congo, The Democratic Republic of the
Facility Name
Hopital Général de réference de Bandundu
City
Bandundu
Country
Congo, The Democratic Republic of the
Facility Name
Hôpital de référence d'Isangi
City
Isangi
Country
Congo, The Democratic Republic of the
Facility Name
Hôpital Général de Référence Roi Baudouin
City
Kinshasa
Country
Congo, The Democratic Republic of the
Facility Name
Centre de Traitement de la THA de Dubreka
City
Dubréka
State/Province
Dubreka
Country
Guinea

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Only for patients from OXA002 participating also in the DiTECT-HAT-WP4, some data (all anonymised) will be shared with L'Institut de Recherche pour le Dévelopment, sponsor of the DiTECT-HAT-WP4 study.

Learn more about this trial

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

We'll reach out to this number within 24 hrs