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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 November 2015
• Main ID: NCT01980199
• Date of registration: 04/11/2013
• Prospective Registration: No
• Primary sponsor: Drugs for Neglected Diseases
• Public title: Trial to Determine Efficacy of Fexinidazole in Visceral Leihmaniasis Patients in Sudan
• Scientific title: Phase II Proof of Concept Trial to Determine Efficacy of Fexinidazole in Visceral Leishmaniasis Patients in Sudan
• Date of first enrolment: November 2013
• Target sample size: 14
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01980199
• Study type: Interventional
• Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Sudan

Contacts

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

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

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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



Age minimum: 15 Years
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Visceral Leishmaniasis

Intervention(s)

Drug: Fexinidazole

Primary Outcome(s)

Initial cure [Time Frame: Day 28]

Secondary Outcome(s)

Final cure [Time Frame: Day 210]

Secondary ID(s)

FEXI VL 001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors