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Fexinidazole in Human African Trypanosomiasis Due to T.b. Gambiense at Any Stage

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ClinicalTrials.gov Identifier: NCT03025789
Recruitment Status : Recruiting
First Posted : January 20, 2017
Last Update Posted : May 30, 2018
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Drugs for Neglected Diseases

Brief Summary:
This study evaluates the effectiveness of fexinidazole administered to patients with g-HAT at all stages of the disease. The aim of the present study is to provide additional information on the effectiveness and safety of fexinidazole and to assess its use under conditions as close as possible to those in real life, both in patients treated on an out-patient basis and in the hospital setting, depending on clinical status

Condition or disease Intervention/treatment Phase
Trypanosomiasis, African Sleeping Sickness Trypanosomiasis; Gambian Drug: Fexinidazole Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 174 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Study Assessing Effectiveness, Safety and Compliance With Fexinidazole in Patients With Human African Trypanosomiasis Due to T.b. Gambiense at Any Stage
Study Start Date : November 2016
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Open label arm
children and adults to receive fexinidazole either as inpatients or outpatients.
Drug: Fexinidazole
Tablets of 600 mg Patients with a weight between 20 and 34kg: 1200mg for 4 days, then 600mg for 6 days Patients with a weight of 35kg and above: 1800mg for 4 days, then 1200mg for 6 days




Primary Outcome Measures :
  1. Outcome (success or failure) [ Time Frame: 18 months follow up ]
    Success is defined as a cure, according to the criteria adapted from the WHO

  2. Outcome (success or failure) [ Time Frame: 12 month follow up ]
    Success is defined as a cure, according to the criteria adapted from the WHO


Secondary Outcome Measures :
  1. Occurrence of grade ≥ 3 adverse events (AEs) including laboratory and haematological abnormalities [ Time Frame: between the first intake of fexinidazole and the end of the observation period or the follow-up period (18 months) for non-serious AEs assessed as related to fexinidazole ]
    AE severity will be graded according to the National Cancer Institute (NCI) Common Toxicity Criteria for AEs (CTCAE), Version 4.03 (13) and, for certain laboratory parameters, modified CTCAE will be used

  2. Occurrence of any serious adverse event (SAE) [ Time Frame: between the first intake of fexinidazole and the end of the follow-up period (18 months) ]
  3. Pharmacokinetic measure to assess patient compliance [ Time Frame: at Day 11 ]
    Presence of fexinidazole and/or its main metabolites in the blood for PK analyses

  4. Outpatients compliance [ Time Frame: at Day 11 ]
    Number of tablets left over and patient's responses to the questionnaire

  5. Outpatients compliance [ Time Frame: at Day 11 ]
    Patient's responses to the questionnaire

  6. Feasibility of self-management of treatment intake in outpatients [ Time Frame: Day 11 ]
    based on interview and left over tablets at D11

  7. questionnaire on acceptability of packaging for outpatients only [ Time Frame: day 0 and day 11 ]
    questionnaire to be completed by patients and caregivers

  8. Whole blood concentration of fexinidazole and its metabolites from dry blood spot of inpatients [ Time Frame: day8, day9, day10, 3hour after treatment administration, Day10, 7h15 after treatment administration, Day10, 24h after treatment administration, Day10, 48h after treatment administration ]
    measured by HPLC/MS/MS Bioanalytical method in all patients treated in hospital



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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patient, including breastfeeding or pregnant women in the second or third trimester.
  • ≥ 6 years of age.
  • ≥ 20 kg body weight.
  • Signed Informed Consent Form and Assent Form for patients less than 18 years of age
  • Trypanosomes detected in any body fluid.
  • Physically able to ingest at least one solid meal per day.
  • Able to take oral medication.
  • Karnofsky Performance Status > 40%.
  • Able to comply with the schedule of follow-up visits and with the study constraints.
  • Easily reachable during the out-patient follow-up period.
  • Willing to undergo lumbar punctures.

Exclusion Criteria:

  • Active clinically relevant medical conditions other than HAT that, in the Investigator's opinion, could jeopardise patient safety or interfere with participation in the study, including but not limited to significant liver or cardiovascular diseases, HIV infection, CNS trauma or seizure disorders, coma or altered consciousness not related to HAT.
  • Severe renal or hepatic impairment defined as:

elevated creatinine at > 3 times the upper limit of normal (ULN) elevated ALT, AST or bilirubin at > 3 ULN

  • Severely deteriorated general condition, such as cardiovascular shock, respiratory distress or terminal illness.
  • Any condition (except symptoms of HAT) that compromises ability to communicate with the Investigator as required for completion of the study.
  • Any contraindication to imidazole products (known hypersensitivity to imidazoles).
  • Treatment for HAT within 2 years prior to inclusion.
  • Prior enrolment in the study or prior intake of fexinidazole.
  • Foreseeable difficulty in complying with the schedule of follow-up visits (migrants, refugees, itinerant traders, etc.).

Temporary Non-inclusion Criteria:

  • Recovery period after antimalarial treatment and/or treatment of helminthiasis (at least 3 days).
  • Uncontrolled diabetes or hypertension or any patients requiring clinical stabilisation; wait until appropriate treatment to control the disease has been initiated.
  • First trimester of pregnancy.
  • Traumatic lumbar puncture at Screening i.e. red blood cells visible in CSF; wait for 48 hours before repeating lumbar puncture.

Eligibility Criteria for Out-patient Treatment

  • Accepting to be treated on an out-patient basis;
  • Karnofsky Performance Status > 50%;
  • Good understanding of the method of administration of fexinidazole by the patient and/or caregiver* (checked using a questionnaire at the time of dispensing fexinidazole);
  • Residing close to the investigational centre, i.e. approximately one hour by road and/or boat, during the treatment period**;
  • Easily reachable during the treatment period;
  • No medical or psychiatric contraindications for treatment as out-patient;
  • No pregnancy or breastfeeding;
  • No neurological symptoms.

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): NCT03025789


Contacts
Contact: Antoine Tarral, Dr +41229069260 atarral@dndi.org
Contact: Christelle Perdrieu, PharmD +41229069236 cperdrieu@dndi.org

Locations
Congo, The Democratic Republic of the
Hôpital de Dipumba Recruiting
Mbuji-Mayi, Kasaï Oriental, Congo, The Democratic Republic of the
Contact: Dieudonné Mpoyi, Doctor       dmpoyi@dndi.org   
Contact: Médard Ilunga, Doctor       milunga@dndi.org   
Principal Investigator: Dieudonné Mpoyi, Doctor         
Sub-Investigator: Médard Ilunga, Doctor         
Hopital General de réference Recruiting
Bagata, Congo, The Democratic Republic of the
Contact: Papy Kavunga, MD       plukula@dndi.org   
Principal Investigator: Papy Kavunga, Doctor         
Sub-Investigator: Mathieu Nkeri, Doctor         
Sub-Investigator: John Twampo, Doctor         
Hopital Général de réference Recruiting
Bandundu, Congo, The Democratic Republic of the
Contact: Helen Mahenzi, MD       hmahenzi@dndi.org   
Principal Investigator: Helene Mahenzi, Doctor         
Sub-Investigator: Joseph MAKAYA, Doctor         
Sub-Investigator: Bedel Mulumba, Doctor         
Hopital de Kimpese Recruiting
Kimpese, Congo, The Democratic Republic of the
Contact: Jean-Papa Mavakala, Dr       jpmavakala@dndi.org   
Principal Investigator: Jean-Papa Mavakala, Dr         
Hôpital Général de Référence Roi Baudouin Recruiting
Kinshasa, Congo, The Democratic Republic of the
Contact: Luwawu Ntoya, Doctor       lntoya@dndi.org   
Principal Investigator: Luwawu Ntoya, Doctor         
Sub-Investigator: Vincent Kobo, Doctor         
Hopital Genral de Reference Masi MAnimba Recruiting
Masi-Manimba, Congo, The Democratic Republic of the
Contact: Willy Kuziena, Doctor         
Principal Investigator: Willy Kuziena Mindele, Doctor         
Sub-Investigator: Augustin Kukembila Musoki, Doctor         
Sub-Investigator: Felix Akwaso Masa, Doctor         
Hopital General de réference Recruiting
Mushie, Congo, The Democratic Republic of the
Contact: Guylain Mandula, MD       gmandula@dndi.org   
Principal Investigator: Guylain Mandula, Doctor         
Sub-Investigator: Tim Mayala, Doctor         
HGR Nkara Recruiting
Nkara, Congo, The Democratic Republic of the
Contact: Steve Inzodi, Dr       sinzodi@dndi.org   
Principal Investigator: Steve Inzodi, Dr         
Guinea
Hopital de Dubreka Recruiting
Dubreka, Guinea
Contact: Mariame Camara, Dr       mcamara@dndi.org   
Principal Investigator: Mariame Camara, Dr         
Sponsors and Collaborators
Drugs for Neglected Diseases
Sanofi
Investigators
Principal Investigator: Victor Kande Betu Kumeso, Dr Ministère de la Santé

Responsible Party: Drugs for Neglected Diseases
ClinicalTrials.gov Identifier: NCT03025789     History of Changes
Other Study ID Numbers: DNDi-FEX-09-HAT
First Posted: January 20, 2017    Key Record Dates
Last Update Posted: May 30, 2018
Last Verified: May 2018

Keywords provided by Drugs for Neglected Diseases:
T.b gambiense
HAT
outpatients

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