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

• Status: Terminated
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Drugs for Neglected Diseases

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