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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Barcelona Centre for International Health Research
ClinicalTrials.gov Identifier:
NCT01755403
First received: December 19, 2012
Last updated: June 20, 2014
Last verified: June 2014
  Purpose

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: Endpoint Classification: Pharmacokinetics Study
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) ] [ Designated as safety issue: No ]
    Population pharmacokinetic model development


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


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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01755403

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

No publications provided

Responsible Party: Barcelona Centre for International Health Research
ClinicalTrials.gov Identifier: NCT01755403     History of Changes
Other Study ID Numbers: CINEBENZ
Study First Received: December 19, 2012
Last Updated: June 20, 2014
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
Spain: Ethics Committee

Additional relevant MeSH terms:
Chagas Disease
Euglenozoa Infections
Parasitic Diseases
Protozoan Infections
Trypanosomiasis
Benzonidazole
Anti-Infective Agents
Antiparasitic Agents
Antiprotozoal Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Trypanocidal Agents

ClinicalTrials.gov processed this record on October 21, 2014