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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Barcelona Centre for International Health Research
ClinicalTrials.gov Identifier:
NCT01755403
First received: December 19, 2012
Last updated: July 8, 2013
Last verified: July 2013
  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.


Estimated Enrollment: 50
Study Start Date: December 2012
Estimated Primary Completion Date: December 2014 (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
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: July 8, 2013
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
Spain: Ethics Committee

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

ClinicalTrials.gov processed this record on April 17, 2014