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Completed

NCT Number: NCT01755403

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

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

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Key information

Conditions

Chagas Disease Euglenozoa Infections Infections Parasitic Diseases Protozoan Infections Trypanosomiasis Vector Borne Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

International Health Department, Hospital Clinic, Barcelona

Barcelona, Catalonia, 08036, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Benznidazole

Drug

Primary outcomes

  1. Population pharmacokinetic parameters of Benznidazole

    Time frame: 2 months (treatment period)

    Population pharmacokinetic model development

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Barcelona Centre for International Health Research

Other

Registry information

Official study title

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

Acronym: CINEBENZ

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 24, 2012
Registry last updated
May 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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