Proof-of-Concept Study of E1224 to Treat Adult Patients With Chagas Disease

• Status: Unknown status
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the safety and efficacy of E1224, a pro-drug of ravuconazole, in individuals with chronic indeterminate Chagas disease recruited in research centres in Tarija and Cochabamba, Bolivia.

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

Details

• Lead Sponsor: Drugs for Neglected Diseases
• Collaborator: Eisai Co., Ltd.
• Treatments: Benzonidazole

Criteria

Screening Criteria:

• Age >18 to < 50 years

• Weight > 40 kg

• Diagnosis of T. cruzi infection by conventional serology (a minimum of two out of three positive tests [enzyme linked immunosorbent assay (ELISA), indirect immunofluorescence (IIF), or hemagglutination inhibition (HAI)])

• Signed, written informed consent form

• No signs and/or symptoms of the chronic cardiac and/or digestive form of CD

• No acute or chronic health conditions that may interfere with the efficacy and/or safety evaluation of the study drug

• No formal contraindication to BZN and E1224

• No known history of hypersensitivity, allergic, or serious adverse reactions to the study drugs

• No history of CD treatment with BZN or NFX at any time in the past

• No history of systemic treatment with itraconazole, ketoconazole, posaconazole, isavuconazole, or allopurinol in the past

Inclusion Criteria:

• Confirmed diagnosis of T. cruzi infection by serial qualitative PCR AND Conventional serology

• Women in reproductive age must have a negative serum pregnancy test at screening, must not be breastfeeding, and consistently use and/or have partner consistently use an adequate contraceptive method

• Normal ECG at screening

Exclusion Criteria:

• Abnormal laboratory test values at screening for the following parameters: total White Blood Cells (WBC) count, platelet count, alanine transaminase (ALT), aspartate transaminase (AST), total bilirubin, or creatinine; or gamma-glutamyl transferase (GGT)

• History of alcohol abuse or any other drug addiction (as specified in the Study Manual of Operations)

• Any condition that prevents the patient from taking oral medication

• Any concomitant use of antimicrobial or antiparasitic agents