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

Brief Title

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

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

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
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Outcome (success or failure)

Secondary Outcome

 Occurrence of grade ≥ 3 adverse events (AEs) including laboratory and haematological abnormalities

Condition

Trypanosomiasis, African

Intervention

Fexinidazole

Study Arms / Comparison Groups

 Open label arm
Description:  children and adults to receive fexinidazole either as inpatients or outpatients.

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

174

Start Date

November 17, 2016

Completion Date

February 1, 2021

Primary Completion Date

February 1, 2021

Eligibility 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.
      

Gender

All

Ages

6 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

NCT03025789

Organization ID

DNDi-FEX-09-HAT


Responsible Party

Sponsor

Study Sponsor

Drugs for Neglected Diseases

Collaborators

 Sanofi

Study Sponsor

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


Verification Date

October 2021