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Trial to Determine Efficacy of Fexinidazole in Visceral Leihmaniasis Patients in Sudan

NCT01980199 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2015-10-30

No results posted yet for this study

Summary

This study is designed to determine the efficacy of Fexinidazole as an oral treatment in Visceral Leishmanisasis sudanese adults patients.

The results of this proof of concept study will allow to make a decision on whether to proceed with clinical development of Fexinidazole for visceral leishmaniasis.

Conditions

  • Visceral Leishmaniasis

Interventions

DRUG

Fexinidazole

600 mg tablets given orally, after the main daily meal * at the daily dose of 1800 mg (3 tablets) once a day for 4 days * continued by 1200mg (2 tablets)once a day for 6 days

Sponsors & Collaborators

  • Drugs for Neglected Diseases

    lead OTHER

Principal Investigators

  • Ahmed M Musa, MD PhD · Director, Institute of Endemic Diseases, University of Khartoum Associate Professor, Head, Department of Clinical Pathology & Immunology

  • E. AG Khalil, Prof. MD · Institute of Endemic Diseases (IED), University of Khartoum

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2014-11-30
Completion
2015-09-30

Countries

  • Sudan

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 NCT01980199 on ClinicalTrials.gov