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

Chagas Disease Clinical Trial

— CINEBENZ  

Official title:

Population Pharmacokinetics in Benznidazole-treated Adults With Chronic Chagas Disease. Benznidazole Pharmacokinetics and Adverse Reactions Relationship.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01755403
• Other study ID #: CINEBENZ
• Status: Completed
• Phase: Phase 4
• First received: December 19, 2012
• Last updated: May 25, 2015
• Start date: December 2012
• Est. completion date: November 2013

Study information

• Verified date: May 2015
• Source: Barcelona Centre for International Health Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos SanitariosSpain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chagas Disease

Intervention

Drug:
• Benznidazole

Locations

Country	Name	City	State
Spain	International Health Department, Hospital Clinic, Barcelona	Barcelona	Cataluña

Sponsors (1)

Lead Sponsor	Collaborator
Barcelona Centre for International Health Research

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Population pharmacokinetic parameters of Benznidazole	Population pharmacokinetic model development	2 months (treatment period)	No
Secondary	Adverse reactions	Number of participants with adverse events. Severity of adverse events. Relationship between adverse event and drug concentration.	2 months (treatment period)	Yes