E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The study will be held in 50 patients with Chronic Chagas Disease. |
En el estudio participarán 50 pacientes diagnosticados de Enfermedad de Chagas crónica. |
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E.1.1.1 | Medical condition in easily understood language |
The study will be held in patients with a chronic disease caused by a parasite called Tripanosoma cruzi. |
El estudio se realizará en pacientes con enfermedad crónica causada por un parásito llamado Tripanosoma cruzi. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Parasitic Diseases [C03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10008384 |
E.1.2 | Term | Chagas' disease |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To study population pharmacokinetics in Benznidazol-treated adult patients with Chronic Chagas Disease to get information to optimaze drug doses. |
Confirmar en una serie de pacientes adultos con Enfermedad de Chagas el comportamiento farmacocinético de Benznidazol con el objetivo de establecer posteriores régimenes de dosificación que permitan optimizar su terapéutica. |
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E.2.2 | Secondary objectives of the trial |
1. To find relationship between Benznidazol pharmacokinetics and other different factors as demographic factors (age, weight, gender), biochemical factors (renal function, hepatic function) or physiopatological factors (adverse reactions), to try to understand drug's interindividual variability.
2. To find if there is any relationship between drug's serum concentration and adverse reactions. |
1. Cuantificar el efecto que ejercen distintos factores como los demográficos (edad, peso, sexo), bioquímicos (función renal y hepática) o fisiopatológicos (aparición de efectos adversos), en el comportamiento farmacocinético de Benznidazol con el fin de explicar su variabilidad interindividual.
2. Establecer una posible relación entre la concentración del fármaco y la aparición de efectos adversos debidos al fármaco. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 Benznidazol.
- Any gender.
- All the participants must agree to participate in the study and must sign the informed consent. |
- Pacientes adultos diagnosticados de Enfermedad de Chagas crónica con 2 serología diferentes positivas.
- Pacientes con Enfermedad de Chagas crónica que empezarán tratamiento con Benznidazol.
- Cualquier género.
- Todos los pacientes deben estar de acuerdo en participar en el estudio y firmar el documento de consentimiento informado.
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E.4 | Principal exclusion criteria |
- Patients yonger than 18.
- Patients with previous hipersensitivity to Benznidazol.
- Inmunocompromised patients as AIDS, cancer, chemoterapy, long-term corticoids need, primary inmunodeficiency, or any other.
- Hepatic dysfunction
- Renal dysfunction: serum creatinin higher than 3 mg/dl.
- Pregnancy or lactation.
- Low adhesion to treatment or check-up.
- Imposibility of follow-up.
- Severe adverse reaction to Benznidazol.
- Any other situation that could be risky for the patient. |
- Pacientes menores de 18 años.
- Pacientes con Hipersensibilidad previa al Benznidazol.
- Pacientes con enfermedades inmunosupresoras como SIDA, cancer, quimioterapia, tratamientos corticoideos de larga duración, immunodeficiencias primarias o cualquier otra situación que pueda compremeter el sistema immune.
- Insuficiencia hepática.
- Insuficiencia renal: creatinina sérica de mayor de 3mg/dl.
- Embarazo o lactancia.
- Baja adherencia al tratamiento o a los controles.
- Reacciones graves al Benznidazol.
- Cualquier otra situación que se considere de riesgo para el paciente. |
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E.5 End points |
E.5.1 | Primary end point(s) |
There is no study held before this one where Benznidazol's population pharmacokinetics have being analyzed, so this will be a pioneering
study. Because of that all the results will be collected. |
No existen estudios previos donde se analice la farmacocinética poblacional del Benznidazol, por lo que este estudio será pionero. Por lo tanto, se intentará extraer toda la información en relación a la farmacocinética poblacional. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Asuming the recruitment and treatment periods, about 18 month will be needed. |
Se estima que se necesitarán unos 18 meses contando con el reclutamiento y tratamiento de los pacientes. |
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E.5.2 | Secondary end point(s) |
To analyze if there is a relationship between Banznidazol's plasma concentration and the seriousness o frecuency of adverse reactions. |
Analizar la posible relación entre la concentración plasmática de Benznidazol y la frecuencia y gravedad de la aparición de efectos adversos. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Asuming the recruitment and treatment periods, about 18 month will be needed. |
Se estima que se necesitarán unos 18 meses, incluyendo el tiempo de reclutamiento y tratamiento de los pacientes. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |