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

Primary Purpose

Chagas Disease

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Benznidazole
Sponsored by
Barcelona Centre for International Health Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chagas Disease

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • International Health Department, Hospital Clinic, Barcelona

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Benznidazole

Arm Description

Outcomes

Primary Outcome Measures

Population pharmacokinetic parameters of Benznidazole
Population pharmacokinetic model development

Secondary Outcome Measures

Adverse reactions
Number of participants with adverse events. Severity of adverse events. Relationship between adverse event and drug concentration.

Full Information

First Posted
December 19, 2012
Last Updated
May 25, 2015
Sponsor
Barcelona Centre for International Health Research
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1. Study Identification

Unique Protocol Identification Number
NCT01755403
Brief Title
Population Pharmacokinetics in Benznidazole-treated Adults With Chronic With Chagas Disease
Acronym
CINEBENZ
Official Title
Population Pharmacokinetics in Benznidazole-treated Adults With Chronic Chagas Disease. Benznidazole Pharmacokinetics and Adverse Reactions Relationship.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Barcelona Centre for International Health Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chagas Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Benznidazole
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Benznidazole
Primary Outcome Measure Information:
Title
Population pharmacokinetic parameters of Benznidazole
Description
Population pharmacokinetic model development
Time Frame
2 months (treatment period)
Secondary Outcome Measure Information:
Title
Adverse reactions
Description
Number of participants with adverse events. Severity of adverse events. Relationship between adverse event and drug concentration.
Time Frame
2 months (treatment period)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joaquim Gascón, PhD
Organizational Affiliation
Barcelona Centre for International Health Research (CRESIB)
Official's Role
Principal Investigator
Facility Information:
Facility Name
International Health Department, Hospital Clinic, Barcelona
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08036
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
29351667
Citation
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.
Results Reference
derived
PubMed Identifier
25824212
Citation
Soy 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.
Results Reference
derived

Learn more about this trial

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

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