Population Pharmacokinetics in Benznidazole-treated Adults With Chronic With Chagas Disease

Phase 4

Completed

• Conditions: Chagas Disease
• Interventions: Drug: Benznidazole

• Registration Number: NCT01755403
• Lead Sponsor: Barcelona Centre for International Health Research

Brief Summary

o study population pharmacokinetics in Benznidazole-treated adult patients with Chronic Chagas Disease to get information to optimize drug doses.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-19
• Study First Submitted QC: 2012-12-19
• Study First Posted: 2012-12-24
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-25
• Last Update Posted: 2015-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• Adult patients with Chronic Chagas Disease diagnosed by 2 different and positive serological tests.
• Patients with Chronic Chagas Disease who are going to start treatment with Benznidazole.
• Any gender.
• All the participants must agree to participate in the study and must sign the informed consent.

Exclusion Criteria

• Patients younger than 18.
• Patients with previous hypersensitivity to Benznidazole.
• Immunocompromised patients as AIDS, cancer, chemotherapy, longterm corticoids need, primary immunodeficiency, or any other.
• Hepatic dysfunction
• Renal dysfunction: serum creatinin higher than 3 mg/dl.
• Pregnancy or lactation.
• Low adhesion to treatment or check-up.
• Impossibility of follow-up.
• Severe adverse reaction to Benznidazole.
• Any other situation that could be risky for the patient.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Benznidazole	Benznidazole	-

Primary Outcome Measures

Name	Time	Method
Population pharmacokinetic parameters of Benznidazole	2 months (treatment period)	Population pharmacokinetic model development

Secondary Outcome Measures

Name	Time	Method
Adverse reactions	2 months (treatment period)	Number of participants with adverse events. Severity of adverse events. Relationship between adverse event and drug concentration.

Trial Locations

Locations (1)

International Health Department, Hospital Clinic, Barcelona; 🇪🇸 Barcelona, Cataluña, Spain