ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 12 of 17 for:    Human African Trypanosomiasis

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03087955
Recruitment Status : Recruiting
First Posted : March 23, 2017
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
Drugs for Neglected Diseases

Brief Summary:
The goal of this study is to assess efficacy and safety of 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
Trypanosomiasis, African Gambiense Trypanosomiasis Sleeping Sickness Drug: SCYX 7158 Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety Study of SCYX-7158 in Patients With Human African Trypanosomiasis (HAT) Due to Trypanosoma Brucei Gambiense: a Multicentre, Open-label, Prospective Study
Actual Study Start Date : October 11, 2016
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SCYX-7158
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: SCYX 7158



Primary Outcome Measures :
  1. Success or failure for patients in late stage HAT [ Time Frame: 18 months follow up ]
    Success is defined as a cure, according to the criteria adapted from the World Health Organization(WHO)


Secondary Outcome Measures :
  1. Success or failure for all stage HAT patients [ Time Frame: 6, 12 and 18 months follow up ]
    Success is defined as a cure, according to the criteria adapted from the WHO

  2. Time to Failure in Patients with Late-stage HAT [ Time Frame: 18 months follow up ]
    Time of the first objective evidence of failure.

  3. Occurence of adverse events [ Time Frame: 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.

  4. Occurence of serious advers events [ Time Frame: 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

  5. Pharmacokinetics measure [ Time Frame: 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);

  6. Pharmacokinetics measure [ Time Frame: 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;

  7. Electrocardiogram measure [ Time Frame: Days 1, 2, 3, 4, 5 and 11 ]
    PR interval

  8. Electrocardiogram measure [ Time Frame: Days 1, 2, 3, 4, 5 and 11 ]
    quantitative description of PR interval

  9. Electrocardiogram measure [ Time Frame: Days 1, 2, 3, 4, 5 and 11 ]
    quantitative description of RR interval

  10. Electrocardiogram measure [ Time Frame: Days 1, 2, 3, 4, 5 and 11 ]
    quantitative description of QRs interval

  11. Electrocardiogram measure [ Time Frame: Days 1, 2, 3, 4, 5 and 11 ]
    quantitative description of QTcF interval



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03087955


Contacts
Contact: Antoine Tarral, Dr +411229069260 antoine.tarral@dndi.org
Contact: Sandra Rembry, PharmD +41229077734 srembry@dndi.org

Locations
Congo, The Democratic Republic of the
Centre de Traitement de NKara Recruiting
Nkara, Bandundu, Congo, The Democratic Republic of the
Contact: Ernest MULENGE, Dr       emulenge@dndi.org   
Principal Investigator: Ernest MULENGE, Dr         
Sub-Investigator: David KIAKEDISI YEMWENI, Dr         
Centre de Traitement de Kimpese Recruiting
Kimpese, Bas Congo, Congo, The Democratic Republic of the
Contact: Aimée Fifi NZEZA BAMBUWO, Dr       fnzeza@dndi.org   
Principal Investigator: Aimée Fifi NZEZA BAMBUWO, Dr         
Sub-Investigator: Jean Papa MAVAKA, Dr         
Hôpital Général de Référence de NGandajika Recruiting
Gandajika, Kasai Oriental, Congo, The Democratic Republic of the
Contact: Sylvain MUTANDA KALONJI, Dr.       smutanda@dndi.org   
Principal Investigator: Sylvain MUTANDA KALONJI, Dr         
Sub-Investigator: Phyll MARIERO PHILEMON, Dr         
Hôpital de Dipumba Recruiting
Mbuji-Mayi, Kasai-Oriental, Congo, The Democratic Republic of the
Contact: Médard ILUNGA, Dr.       milunga@dndi.org   
Contact: Dieudonné MPOYI, Dr.       dmpoyi@dndi.org   
Principal Investigator: Médard ILUNGA, Dr         
Sub-Investigator: Dieudonné MPOYI, Dr         
Hôpital secondaire de Katanda Recruiting
Katanda, Kasaï-Oriental, Congo, The Democratic Republic of the
Contact: Lewis KANINDA BADIBABI, Dr.       lkaninda@dndi.org   
Contact: Serge KAPONGO TSHILUMBWA, Dr.       skapongo@dndi.org   
Principal Investigator: Lewis KANINDA BADIBABI, Dr         
Sub-Investigator: Serge KAPONGO TSHILUMBWA, Dr         
Hopital General de réference de Bagata Recruiting
Bagata, Kwilu, Congo, The Democratic Republic of the
Contact: Papy KAVUNGA LUKULA, Dr       plukula@dndi.org   
Contact: Mathieu NKIERI MATSHO, Dr       mmatsho@dndi.org   
Principal Investigator: Papy KAVUNGA LUKULA, Dr         
Sub-Investigator: Mathieu NKIERI MATSHO, Dr         
Hôpital Général de référence de Masi-Manimba Recruiting
Masi-Manimba, Kwilu, Congo, The Democratic Republic of the
Contact: Félix AKWASO, Dr.       fakwaso@dndi.org   
Contact: Willy KUZIENA, Dr.       wkuziena@dndi.org   
Principal Investigator: Félix AKWASO, Dr         
Sub-Investigator: Willy KUZIENA, Dr         
Hôpital General de référence de Bolobo Withdrawn
Bolobo, Mai-Ndombe, Congo, The Democratic Republic of the
Hôpital Généal de référence de Kwamouth Recruiting
Kwamouth, Mai-Ndombe, Congo, The Democratic Republic of the
Contact: Hugues EMBANA MANKIARA, Dr.       hembana@dndi.org   
Principal Investigator: Hugues EMBANA MANKIARA, Dr         
Sub-Investigator: Jephté MBOKOSO SILAY, Dr         
Hopital Général de réference de Bandundu Recruiting
Bandundu, Congo, The Democratic Republic of the
Contact: Helen Mahenzi, Dr       hmahenzi@dndi.org   
Principal Investigator: Helen Mahenzi, Dr         
Sub-Investigator: Joseph Makaya, Dr         
Hôpital de référence d'Isangi Recruiting
Isangi, Congo, The Democratic Republic of the
Contact: Augustin KASONGO BONAMA, Dr.       akasongo@dndi.org   
Contact: Franck BOTALEMA GELENGI       fbotalema@dndi.org   
Principal Investigator: Augustin KASONGO BONAMA, Dr         
Sub-Investigator: Franck BOTALEMA GELENGI, Dr         
Hôpital Général de Référence Roi Baudouin Recruiting
Kinshasa, Congo, The Democratic Republic of the
Contact: Vincent KOBO MUANZA, Dr       vkobo@dndi.org   
Principal Investigator: Vincent KOBO MUANZA, Dr         
Sub-Investigator: Serge LUWAWU NTOYA, Dr         
Guinea
Centre de Traitement de la THA de Dubreka Recruiting
Dubréka, Dubreka, Guinea
Contact: Mariame CAMARA, Dr       mcamara@dndi.org   
Principal Investigator: Mariame CAMARA, Dr         
Sub-Investigator: Ansumane KOUROUMA, Dr         
Sponsors and Collaborators
Drugs for Neglected Diseases
Investigators
Principal Investigator: Victor Kande Betu Kumeso, Dr Ministère de la Santé

Responsible Party: Drugs for Neglected Diseases
ClinicalTrials.gov Identifier: NCT03087955     History of Changes
Other Study ID Numbers: DNDi-OXA-02-HAT
First Posted: March 23, 2017    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Trypanosomiasis
Trypanosomiasis, African
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases