E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Treatment and prevention of CMV disease in kidney transplant recipients |
Tratamiento y Prevención de la enfermedad por CMV en receptores de trasplante renal |
|
E.1.1.1 | Medical condition in easily understood language |
Treatment and prevention of Human cytomegalovirus (CMV), a serious infection complicating kidney transplantation |
Tratamiento y prevencion de citomegalovirus humano (CMV), infeccion grave que complica el trasplante renal |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10009701 |
E.1.2 | Term | CMV |
E.1.2 | System Organ Class | 10022891 - Investigations |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10049107 |
E.1.2 | Term | CMV viraemia |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10009703 |
E.1.2 | Term | CMV infection |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10060577 |
E.1.2 | Term | CMV viremia |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
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 |
• The primary objective of this study is to describe the tolerability profile of up to 200 days prophylaxis of valganciclovir oral solution and tablets in pediatric kidney transplant recipients |
• El objetivo principal de este estudio es describir el perfil de tolerabilidad de la profilaxis de hasta 200 días con solución oral y comprimidos de valganciclovir en receptores pediátricos de trasplante de riñón |
|
E.2.2 | Secondary objectives of the trial |
• To describe the incidence of CMV infection (viremia) and disease (CMV syndrome or tissue invasive CMV) within the first 52 weeks post transplant.
• To describe the incidence and nature of CMV resistance to ganciclovir (mutations in UL97 and/or UL54) |
• Describir la incidencia de la infección (viremia) y la enfermedad por CMV (síndrome de CMV o enfermedad invasiva de tejidos por CMV) en las primeras 52 semanas después del trasplante
• Describir a incidencia y la naturaleza de la resistencia del CMV a ganciclovir (mutaciones en UL97 y/o UL54). |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Parent or guardian of patient willing and able to give written informed consent; the written assent from the child is also required if he/she is old enough to understand the risks and benefits of the study.
2. Patient has received a kidney transplant.
3. Males or females aged between 4 months and ≤ 16 years.
4. Patient at risk of developing CMV disease (including R+ who are at risk of CMV due to other factors determined by the treating physician).
5. Patient has adequate hematological and renal function defined as: • Absolute neutrophil count (ANC) >1300 cells/μL • Platelet count >40,000 cells/μL • Hemoglobin >8.0 g/dL • Estimated Schwartz creatinine clearance (>15 mL/min) to allow for dosing according to algorithm 6. Patient is able to tolerate oral medication (any standard practice tube feeding is acceptable).
7. Negative pregnancy test (blood or urine) for females of child bearing potential before initiation of valganciclovir treatment.
8. Patients of reproductive potential agree to utilize an effective method of contraception throughout the study period and for 90 days following discontinuation of study drug (abstinence is a valid method of contraception) |
1.Los padres o el tutor del paciente deberán estar dispuestos y ser capaces de otorgar un consentimiento informado por escrito; también se exige la aceptación del niño si tiene la edad suficiente para entender los riesgos y beneficios del estudio.
2.El paciente ha sido sometido a un trasplante de riñón.
3.Niños o niñas de edad comprendida entre 4 meses y 16 años.
4.Paciente con riesgo de desarrollar enfermedad por CMV (incluidos R+ con riesgo de CMV debido a otros factores determinados por el médico que les trate).
5.Paciente con función hematológica y renal adecuada, definida como: •Recuento absoluto de neutrófilos (RAN) > 1300 células/μl •Recuento plaquetario > 40.000 células/μl •Hemoglobina > 8,0 g/dl •Aclaramiento de creatinina estimado por Schwartz (> 15 ml/min) que permita la dosificación según el algoritmo
6.Paciente capaz de tolerar la medicación oral (es aceptable cualquier práctica habitual de alimentación por sonda nasogástrica).
7.Prueba negativa de embarazo (sangre u orina) para chicas en edad fértil antes de iniciar el tratamiento con valganciclovir.
8.Los pacientes con capacidad reproductiva aceptan utilizar un método anticonceptivo eficaz a lo largo de todo el período del estudio y durante 90 días después de suspenderse el medicamento del estudio (la abstinencia es un método anticonceptivo válido). |
|
E.4 | Principal exclusion criteria |
1. Patient has exhibited an allergic or other significant adverse reaction to acyclovir, valacyclovir or ganciclovir in the past.
2. Patient has severe, uncontrolled diarrhea (more than 5 watery stools per day).
3. Patient has liver enzyme elevation of more than five times the upper limit of normal for AST (SGOT) or ALT (SGPT).
4. Patient requires use of any protocol prohibited concomitant medications.
5. Patient has previously participated in this clinical study.
6. Patient is a lactating female who will not discontinue nursing prior to study entry.
7. Patient is simultaneously participating in another clinical study except as approved by the Sponsor. |
1.El paciente ha presentado una reacción alérgica u otra reacción adversa significativa a aciclovir, valaciclovir o ganciclovir en el pasado.
2.El paciente presenta diarrea grave no controlada (más de 5 deposiciones líquidas al día).
3.El paciente tiene las enzimas hepáticas elevadas más de cinco veces por encima del límite superior de la normalidad para AST (SGOT) o ALT (SGPT).
4.El paciente necesita utilizar medicamentos concomitantes prohibidos por el protocolo.
5.El paciente ha participado anteriormente en este estudio clínico.
6.La paciente es una mujer en período de lactancia que no suspenderá la lactancia antes de ingresar en el estudio.
7.El paciente está participando simultáneamente en otro estudio clínico, excepto en el caso de que sea aprobado por el promotor. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
To describe the tolerability profile of up to 200 days prophylaxis of valganciclovir oral solution and tablets in pediatric kidney transplant recipients |
Describir el perfil de tolerabilidad de la profilaxis de hasta 200 días con solución oral y comprimidos de valganciclovir en receptores pediátricos de trasplante de riñón |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Up to 52 weeks post-transplant |
Hasta 52 semanas después del trasplante |
|
E.5.2 | Secondary end point(s) |
To describe the incidence of CMV infection and disease within the first 52 weeks post-transplant
To describe the incidence and nature of resistance to ganciclovir |
Describir la incidencia de la infección y enfermedad por CMV en las primeras 52 semanas después del trasplante
Describir la incidencia y la naturaleza de la resistencia a ganciclovir |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Up to 52 weeks post-transplant |
Hasta 52 semanas después del trasplante |
|
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 | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
Tolerability |
Tolerabilidad |
|
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 12 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Australia |
Brazil |
France |
Germany |
Mexico |
Spain |
Sweden |
United Kingdom |
United States |
|
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
|
The end of the study is defined as the last patients’ last visit |
El final del estudio se define como la última visita último paciente. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | 15 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 11 |
E.8.9.2 | In all countries concerned by the trial days | 15 |