Status:
UNKNOWN
Proof-of-Concept Study of E1224 to Treat Adult Patients With Chagas Disease
Lead Sponsor:
Drugs for Neglected Diseases
Collaborating Sponsors:
Eisai Co., Ltd.
Conditions:
Chronic Chagas Disease, Indeterminate
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
Brief 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, Bo...
Detailed Description
Chagas disease (CD) ranks among the world's most neglected diseases. In Latin America, 21 countries are endemic for CD with an estimated 108 million people at risk of contracting the disease. Estimate...
Eligibility Criteria
Inclusion
- 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
- 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
- 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
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2013
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT01489228
Start Date
June 1 2011
End Date
December 1 2013
Last Update
December 21 2011
Active Locations (2)
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1
Plataforma de Atención Integral a los Pacientes con Enfermidad de Chagas
Cochabamba, Departamento de Cochabamba, Bolivia
2
Plataforma de Atención Integral a los Pacientes con Enfermidad de Chagas
Tarija, Tarija Department, Bolivia