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Efficacy and Safety of Fexinidazole in Patients With Stage 1 or Early Stage 2 Human African Trypanosomiasis (HAT) Due to T.b. Gambiense: a Prospective, Multicentre, Open-label Cohort Study, plug-in to the Pivotal Study

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02169557
Recruitment Status : Completed
First Posted : June 23, 2014
Last Update Posted : June 24, 2020
Sponsor:
Information provided by (Responsible Party):
Drugs for Neglected Diseases

Tracking Information
First Submitted Date  ICMJE May 15, 2014
First Posted Date  ICMJE June 23, 2014
Last Update Posted Date June 24, 2020
Actual Study Start Date  ICMJE April 30, 2014
Actual Primary Completion Date October 9, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2014)
Outcome (success or failure) at the test of cure (ToC) visit 12 months after the end of treatment (EOT). [ Time Frame: 12 months after end of treatment (day 11) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2014)
Success or failure at each visit between the End of treatment and 18 months visit. [ Time Frame: End of treatment (day 11) to last follow-up visit (18 months) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 19, 2014)
Safety [ Time Frame: From signature of informed consent to 18 months Follow up visit ]
  • Occurrence of any grade AEs (all grades combined) during the observation period.
  • Occurrence of drug-related AEs (Grade ≥ 3 and any grade) during the observation period.
  • Occurrence of any serious adverse events (SAE) from first drug intake to the end of follow up period (M18).
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Fexinidazole in Patients With Stage 1 or Early Stage 2 Human African Trypanosomiasis (HAT) Due to T.b. Gambiense: a Prospective, Multicentre, Open-label Cohort Study, plug-in to the Pivotal Study
Official Title  ICMJE Efficacy and Safety of Fexinidazole in Patients With Stage 1 or Early Stage 2 Human African Trypanosomiasis (HAT) Due to T.b. Gambiense: a Prospective, Multicentre, Open-label Cohort Study, plug-in to the Pivotal Study
Brief Summary The purpose of this study is to demonstrate the treatment success of fexinidazole, at one year follow-up visit, in HAT stage 1 and early stage 2 patients.
Detailed Description

Primary Objective

-To demonstrate that the success rate of fexinidazole at one year follow-up in stage 1 and early stage 2 patients is greater than 80%. An 80 % success rate is considered as unacceptable.

Secondary Objectives

  • To verify whether the success rate of fexinidazole treatment depends on the stage of the disease (stage 1 versus early stage 2); and, if the difference between the 2 stages is significant, to show that the success rate is greater than 80% and compatible with the historical success rate of NECT in early stage 2 patients and with the historical success rate of pentamidine in stage 1 patients.
  • To verify whether the success rate of fexinidazole treatment depends on the number of WBCs in CSF before treatment initiation.
  • To assess changes in the success rate over time.
  • To evaluate the safety of fexinidazole and determine whether its safety profile is comparable to the historical safety profile of pentamidine.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Human African Trypanosomiasis (HAT)
Intervention  ICMJE Drug: Fexinidazole
Study Arms  ICMJE Experimental: Fexinidazole
Intervention: Drug: Fexinidazole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 6, 2016)
230
Original Estimated Enrollment  ICMJE
 (submitted: June 19, 2014)
202
Actual Study Completion Date  ICMJE April 25, 2017
Actual Primary Completion Date October 9, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Signed informed consent
  • 15 years old or more
  • Male or female
  • Ability to ingest at least one complete meal per day (or at least one Plumpy'Nut® sachet)
  • Karnofsky index > 50
  • Presence of trypanosomes in blood or lymph
  • Absence of trypanosomes in CSF
  • Permanent address and ability to comply with the follow-up visit schedule
  • Patient agreeing to be hospitalized to receive the treatment

Exclusion Criteria:

  • Severely malnutrition, defined as BMI < 16.
  • Inability to take oral medication.
  • Pregnancy or breastfeeding (a urine pregnancy test will be performed in all women of childbearing age within 24 h prior to treatment).
  • Clinically relevant medical condition other than HAT that, in the Investigator's opinion, may jeopardize patient safety or interfere with participation in the study, including but not limited to significant liver or cardiovascular disease, documented or suspected active infection (including AIDS), CNS trauma or seizure disorders, coma or altered consciousness.
  • Severely deteriorated general condition, e.g. cardiovascular shock, respiratory distress syndrome, or terminal illness.
  • Any medical condition (except HAT specific symptoms) hindering communication with the Investigator as required for the completion of this study.
  • Any contraindication to imidazole products (known hypersensitivity to imidazoles).
  • History of HAT treatment in the past 2 years.
  • Patients previously enrolled in the study or having already received fexinidazole.
  • Expected follow-up difficulties (migrants, refugees, itinerant vendors, etc.).
  • Current alcohol or drug abuse.
  • Clinically significant abnormal laboratory value, such as:
  • Alanine aminotransferase (ALAT) and/or aspartate aminotransferase (ASAT) > 2 times ULN
  • Total bilirubin (TBIL) > 1.5 times ULN
  • Severe leukopenia (< 2000/mm3)
  • Potassium (K+) < 3.5 mmol/L
  • Any clinically significant abnormal value (see details in Investigator Manual)
  • Pregnancy confirmed by a positive urine pregnancy test obtained within 24 h prior to start of study treatment (see Section 5.8.3 Contraception; p35) QTcF ≥ 450 ms as measured automatically (if the first measurement is abnormal, a second assessment will be done at least 10-20 min later, with the patient in resting position)
  • Patients not tested for malaria and/or not treated adequately for this infection
  • Patients not treated adequately for soil-transmitted helminthic diseases
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Congo, The Democratic Republic of the
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02169557
Other Study ID Numbers  ICMJE DNDiHATFEX005
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Drugs for Neglected Diseases
Study Sponsor  ICMJE Drugs for Neglected Diseases
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Drugs for Neglected Diseases
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP