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Pivotal Study of Fexinidazole for Human African Trypanosomiasis in Stage 2

NCT01685827 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 394

Last updated 2018-02-20

No results posted yet for this study

Summary

This clinical trial is designed to prove the efficacy and safety of Fexinidazole as an oral treatment for human african trypanosomiasis in advanced stage. The Fexinidazole is compared to reference treatment NECT. The trial will try to demonstrate that Fexinidazole is not inferior to NECT treatment.

Conditions

  • Human African Trypanosomiasis (HAT)
  • Sleeping Sickness

Interventions

DRUG

Fexinidazole

DRUG

Nifurtimox

DRUG

Eflornithine

Sponsors & Collaborators

  • Drugs for Neglected Diseases

    lead OTHER

Principal Investigators

  • Victor KANDE, MD · HAT National Control Program in DRC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2016-11-11
Completion
2017-04-26

Countries

  • Central African Republic
  • Democratic Republic of the Congo
  • Republic of the Congo

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01685827 on ClinicalTrials.gov