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

NCT01980199 | Terminated Phase 2

• 1 other identifier: FEXI VL 001
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

visceral leishmaniasis; fexinidazole; adults; proof of concept; efficacy; safety; pharmacokinetic; pharmacodynamic

Outcome Measures

Primary Outcomes (1)

• Initial cure

  Proportion of patients with an abscence of parasites in tissue aspirate and no rescue treatment administered up to and including day 28

  Day 28

Secondary Outcomes (1)

• Final cure

  Day 210

Other Outcomes (4)

• Safety endpoint

  From first dose of trial medication to day 56 for non serious AEs and to day 210 for SAEs

• Safety endpoint

  From first dose of trial medication to day 56

• Pharmacokinetic assessment

  From day 1 to day 12

Study Arms (1)

Fexinidazole

EXPERIMENTAL

600mg tablets 3 tablets once a day for 4 days continued by 2 tablets once a day for 6 days

Drug: Fexinidazole

Interventions

Fexinidazole DRUG

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

Fexinidazole

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with clinical signs and symptoms of primary VL (fever for at least 2 weeks, splenomegaly) and diagnosis confirmed by visualization of parasites in tissue samples (lymph node, bone marrow) on microscopy.
• Patients aged between 15 and 60 years (inclusive) who are able to comply with the protocol.
• Patients for whom written informed consent has been signed by the patients themselves (if aged 18 years and over) or by parents(s) or legal guardian for patients under 18 years of age together with the patients assent.
• HIV negative status

You may not qualify if:

• Patients who have previously been diagnosed with VL and received anti-leishmanial treatment (ie relapse)
• Patients with BMI \<16 kg/m2
• Patients with contra-indication (known hypersensitivity) to other imidazoles (e.g. ketaconazole)
• Patients suffering from a concomitant severe underlying disease (cardiac, renal, hepatic) including hepatitis B, para kala-azar dermal leishmaniasis and tuberculosis
• Patient with clinically significant ECG findings or QTcF≥ 450 msec in 2 successive ECGs
• Major surgical intervention 4 weeks prior to enrollment.
• Patients who are pregnant or lactating.
• Female patients of child bearing age who do not agree to use an acceptable method of contraception
• Patients with haemoglobin \< 5g/dl.
• Patients with platelets \< 40,000/mm³.
• Patients with liver function (ALT and AST) tests of more than 2 times the upper limit of the normal range.
• Patients with serum creatinine above the normal range for age and gender.
• Patients with serum potassium (K+) above the normal range
• Patients with Bilirubin more than 1.5 times the upper limit of the normal range

Sponsors & Collaborators

• Drugs for Neglected Diseases: lead

Study Sites (1)

Doka Hospital

Doka, Al Qaḑārif, Sudan

Location

MeSH Terms

Conditions

Leishmaniasis, Visceral

Interventions

fexinidazole

Condition Hierarchy (Ancestors)

Leishmaniasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Vector Borne Diseases

Study Officials

• Ahmed M Musa, MD PhD

  Director, Institute of Endemic Diseases, University of Khartoum Associate Professor, Head, Department of Clinical Pathology & Immunology

  PRINCIPAL INVESTIGATOR

• E. AG Khalil, Prof. MD

  Institute of Endemic Diseases (IED), University of Khartoum

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2013
• First Posted: November 8, 2013
• Study Start: November 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: September 1, 2015
• Last Updated: October 30, 2015

Record last verified: 2014-07

Locations

SU (1)