<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02184689</url>
  </required_header>
  <id_info>
    <org_study_id>DNDiHATFEX006</org_study_id>
    <nct_id>NCT02184689</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Fexinidazole in Children at Least 6 Years Old and Weighing Over 20 kg With Human African Trypanosomiasis (HAT) Due to T.b. Gambiense: a Prospective, Multicentre, Open Study, plug-in to the Pivotal Study</brief_title>
  <official_title>Efficacy and Safety of Fexinidazole in Children at Least 6 Years Old and Weighing Over 20 kg With Human African Trypanosomiasis (HAT) Due to T.b. Gambiense: a Prospective, Multicentre, Open Study, plug-in to the Pivotal Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Drugs for Neglected Diseases</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Drugs for Neglected Diseases</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to assess the efficacy and safety of an oral regimen of fexinidazole&#xD;
      (once daily for 10 days) in the treatment of stage 1 and stage 2 T.b. gambiense sleeping&#xD;
      sickness in children at least 6 years old and over 20 kg bodyweight.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 3, 2014</start_date>
  <completion_date type="Actual">June 27, 2017</completion_date>
  <primary_completion_date type="Actual">December 14, 2016</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Outcome (success or failure) at the test of cure (ToC)</measure>
    <time_frame>12 months after the end of treatment</time_frame>
    <description>Success at 12 months, adapted from the WHO criteria (51), is defined as a cured patient:&#xD;
Patient alive;&#xD;
AND no evidence of trypanosomes in any body fluid;&#xD;
AND WBC ≤20/µL in CSF.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">125</enrollment>
  <condition>Human African Trypanosomiasis (HAT)</condition>
  <arm_group>
    <arm_group_label>Fexinidazole</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>fexinidazole</intervention_name>
    <arm_group_label>Fexinidazole</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed consent form signed by one of the parents or the child's legal representative&#xD;
&#xD;
          -  Child assent to participate in the study collected in the presence of an impartial&#xD;
             witness&#xD;
&#xD;
          -  Age between 6 and 15 years old&#xD;
&#xD;
          -  &gt; 20 Kg bodyweight&#xD;
&#xD;
          -  Boy or girl&#xD;
&#xD;
          -  Able to ingest at least one complete meal per day (or at least one Plumpy'Nut® sachet)&#xD;
&#xD;
          -  Able to swallow 600mg fexinidazole tablets&#xD;
&#xD;
          -  Karnofsky index &gt; 50&#xD;
&#xD;
          -  Presence of trypanosomes in blood and/or lymph and/or CSF&#xD;
&#xD;
          -  Permanent address and ability to comply with follow-up visit schedule&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Child refusing to be included in the trial&#xD;
&#xD;
          -  Bodyweight &lt; 20 Kg&#xD;
&#xD;
          -  Severe malnutrition, defined as having a BMI below 16 (- 2 Z-score of the norm&#xD;
             according to WHO 2007 Growth reference data)&#xD;
&#xD;
          -  Inability to take oral medication&#xD;
&#xD;
          -  Pregnancy or breastfeeding&#xD;
&#xD;
          -  Clinically relevant medical condition other than HAT that, in the Investigator's&#xD;
             opinion, may jeopardize subject safety or interfere with participation in the study,&#xD;
             including but not limited to significant liver or cardiovascular disease, active&#xD;
             documented or suspected infection, central nervous system (CNS) trauma or seizure&#xD;
             disorders, coma or altered consciousness&#xD;
&#xD;
          -  Severely deteriorated general condition, such as cardiovascular shock, respiratory&#xD;
             distress, or terminal illness&#xD;
&#xD;
          -  Any medical condition (except HAT-specific symptoms) hindering communication with the&#xD;
             Investigator as required for the completion of this study&#xD;
&#xD;
          -  Any contraindication to imidazole products (known hypersensitivity to imidazoles)&#xD;
&#xD;
          -  History of HAT treatment in the past 2 years&#xD;
&#xD;
          -  Patients previously enrolled in the study or having already received fexinidazole.&#xD;
&#xD;
          -  Expected follow-up difficulties (migrants, refugees, itinerant vendors, etc.).&#xD;
&#xD;
          -  Current alcohol or drug abuse&#xD;
&#xD;
          -  Clinically significant abnormal laboratory findings, including ASAT and/or ALAT &gt; 2&#xD;
             times ULN // Total bilirubin &gt; 1.5 times ULN // Severe leukopenia (&lt; 2000/mm3) //&#xD;
             Potassium (K+) &lt; 3.5 mmol // Any other clinically significant abnormal laboratory&#xD;
             value (see details in Investigator Manual)&#xD;
&#xD;
          -  Pregnancy confirmed by a positive urine pregnancy test obtained within 24 hours (h)&#xD;
             prior to start of study treatment (see Section 5.8.3 Contraception; p36) for girls&#xD;
             over 12 years old and over&#xD;
&#xD;
          -  ECG abnormalities assessed by a central cardiologist&#xD;
&#xD;
          -  QTcF≥ 450 ms, as measured automatically (if first measurement is abnormal, a second&#xD;
             assessment will be done at least 10-20 min later, with the patient in resting&#xD;
             position).&#xD;
&#xD;
          -  Patients not tested for malaria and/or not treated adequately for this infection&#xD;
&#xD;
          -  Patients not treated adequately for soil transmitted helminthic diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <address>
        <city>Kinshasa</city>
        <country>Congo, The Democratic Republic of the</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Congo, The Democratic Republic of the</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 19, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>June 23, 2020</last_update_submitted>
  <last_update_submitted_qc>June 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Trypanosomiasis</mesh_term>
    <mesh_term>Trypanosomiasis, African</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02184689
org study id: DNDiHATFEX006
nct id: NCT02184689
lead sponsor: 
has dmc: Yes
The aim of the study is to assess the efficacy and safety of an oral regimen of fexinidazole
      (once daily for 10 days) in the treatment of stage 1 and stage 2 T.b. gambiense sleeping
      sickness in children at least 6 years old and over 20 kg bodyweight.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Outcome (success or failure) at the test of cure (ToC)
time frame: 12 months after the end of treatment
description: Success at 12 months, adapted from the WHO criteria (51), is defined as a cured patient:
Patient alive;
AND no evidence of trypanosomes in any body fluid;
AND WBC ≤20/µL in CSF.
arm group label: Fexinidazole
arm group type: Experimental
intervention type: Drug
intervention name: fexinidazole
arm group label: Fexinidazole
criteria: 
gender: All
minimum age: 6 Years
maximum age: 14 Years
healthy volunteers: No
facility: 
country: Congo, The Democratic Republic of the
responsible party type: Sponsor
mesh term: Trypanosomiasis
mesh term: Trypanosomiasis, African