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Population Pharmacokinetics in Benznidazole-treated Adults With Chronic With Chagas Disease (CINEBENZ)

This study has been completed.
Information provided by (Responsible Party):
Barcelona Centre for International Health Research Identifier:
First received: December 19, 2012
Last updated: May 25, 2015
Last verified: May 2015
o study population pharmacokinetics in Benznidazole-treated adult patients with Chronic Chagas Disease to get information to optimize drug doses.

Condition Intervention Phase
Chagas Disease
Drug: Benznidazole
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Population Pharmacokinetics in Benznidazole-treated Adults With Chronic Chagas Disease. Benznidazole Pharmacokinetics and Adverse Reactions Relationship.

Resource links provided by NLM:

Further study details as provided by Barcelona Centre for International Health Research:

Primary Outcome Measures:
  • Population pharmacokinetic parameters of Benznidazole [ Time Frame: 2 months (treatment period) ]
    Population pharmacokinetic model development

Secondary Outcome Measures:
  • Adverse reactions [ Time Frame: 2 months (treatment period) ]
    Number of participants with adverse events. Severity of adverse events. Relationship between adverse event and drug concentration.

Enrollment: 52
Study Start Date: December 2012
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Benznidazole Drug: Benznidazole


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01755403

International Health Department, Hospital Clinic, Barcelona
Barcelona, Cataluña, Spain, 08036
Sponsors and Collaborators
Barcelona Centre for International Health Research
Principal Investigator: Joaquim Gascón, PhD Barcelona Centre for International Health Research (CRESIB)
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Barcelona Centre for International Health Research Identifier: NCT01755403     History of Changes
Other Study ID Numbers: CINEBENZ
Study First Received: December 19, 2012
Last Updated: May 25, 2015

Additional relevant MeSH terms:
Chagas Disease
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Trypanocidal Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents processed this record on May 22, 2017