Population Pharmacokinetics in Benznidazole-treated Adults With Chronic With Chagas Disease
CINEBENZ
1 other identifier
interventional
52
1 country
1
Brief Summary
o study population pharmacokinetics in Benznidazole-treated adult patients with Chronic Chagas Disease to get information to optimize drug doses.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Dec 2012
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 19, 2012
CompletedFirst Posted
Study publicly available on registry
December 24, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedMay 27, 2015
May 1, 2015
11 months
December 19, 2012
May 25, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Population pharmacokinetic parameters of Benznidazole
Population pharmacokinetic model development
2 months (treatment period)
Secondary Outcomes (1)
Adverse reactions
2 months (treatment period)
Study Arms (1)
Benznidazole
OTHERInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
International Health Department, Hospital Clinic, Barcelona
Barcelona, Catalonia, 08036, Spain
Related Publications (2)
Aldasoro E, Posada E, Requena-Mendez A, Calvo-Cano A, Serret N, Casellas A, Sanz S, Soy D, Pinazo MJ, Gascon J. What to expect and when: benznidazole toxicity in chronic Chagas' disease treatment. J Antimicrob Chemother. 2018 Apr 1;73(4):1060-1067. doi: 10.1093/jac/dkx516.
PMID: 29351667DERIVEDSoy D, Aldasoro E, Guerrero L, Posada E, Serret N, Mejia T, Urbina JA, Gascon J. Population pharmacokinetics of benznidazole in adult patients with Chagas disease. Antimicrob Agents Chemother. 2015;59(6):3342-9. doi: 10.1128/AAC.05018-14. Epub 2015 Mar 30.
PMID: 25824212DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joaquim Gascón, PhD
Barcelona Centre for International Health Research (CRESIB)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2012
First Posted
December 24, 2012
Study Start
December 1, 2012
Primary Completion
November 1, 2013
Study Completion
November 1, 2013
Last Updated
May 27, 2015
Record last verified: 2015-05