Study of the pharmacokinetic profile in a multiple dose scheme for the drug Benznidazole in patients with Chronic Chagas Disease Indeterminate Form – Relationship with demographic profiles and adverse events and implications for future trials for combination therapy of Chagas Disease

Overview

No summary available.

Registry

who.int

Start Date

November 8, 2021

End Date

December 1, 2023

Last Updated

2 years ago

Study Type

Observational

Sponsor

•Adult patients with Chagas disease indeterminate form of both sexes, aged between 18 and 70 years old.

•Patients with a history of previous treatment with benznidazol (BZ), contraindications or hypersensitivity to the use of BZ, renal or hepatic failure, gastrointestinal disorders or other condition that interferes with the processes of absorption, distribution, excretion or metabolism of the drug, pulmonary, epileptic, hematological or psychiatric, pregnancy or lactation, associated heart disease such as moderate or severe orovalvular disease, ischemic, congenital or hypertensive heart disease, comorbidities such as malignant tumors and HIV infection, cognitive limitation that does not allow the correct understanding of the IC and the stages of the project, individuals participating in other investigations with interventions, using three or more medications of regular use within the 02 weeks prior to the start of the study treatment, except contraceptives (for women), omeprazole and simvastatin, or any eventual medication within 07 days before the start of study treatment, except dipyrone and paracetam ol, with a history of treatment within the 3 months prior to the study with any drug with known toxic potential in large organs. Participants with a history of loss or donation of 450 mL or more of blood within the three months prior to the scheduled visit date will also be excluded.