E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Cytomegalovirus Infection in subjects who underwent lung transplantation. |
Infección por citomegalovirus en pacientes trasplantados de pulmón. |
|
E.1.1.1 | Medical condition in easily understood language |
Virus Infection in subjects who underwent lung transplantation. |
Infección por virus en pacientes trasplantados de pulmón. |
|
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 | 20.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10011831 |
E.1.2 | Term | Cytomegalovirus infection |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10010187 |
E.1.2 | Term | Complications of transplanted lung |
E.1.2 | System Organ Class | 10022117 - Injury, poisoning and procedural complications |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10025127 |
E.1.2 | Term | Lung transplant |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
|
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 assess the efficacy of reduced duration prophylaxis followed by immuno-guided prophylaxis to prevent cytomegalovirus disease. |
Evaluar la eficacia de la profilaxis de duración reducida seguida de la profilaxis inmunoguiada para evitar la enfermedad por citomegalovirus. |
|
E.2.2 | Secondary objectives of the trial |
In those subjects recruited within the experimental arm who develop citomegalovirus disease despite receiving the immuno-guided prophylaxis based on QF-reactive (cut-off point of 0.2 UI/mL), it will be assessed if a different cut-off point might predict the protection against the disease with greater reliability. |
En aquellos pacientes del brazo experimental en los que, utilizando la profilaxis inmunoguiada basada en QF-reactivo (cut-off 0.2 UI/mL), el paciente desarrolle enfermedad por citomegalovirus, un objetivo secundario será valorar si un punto de corte diferente podría predecir con mayor fiabilidad protección frente a la enfermedad. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subjects with cytomegalovirus positive serology who underwent lung transplantation. Subjects of 18 years of age or older. Expected valgancilovir prophylactic treatment of 6 months after transplantation. Patients who have signed the informed consent form. |
Trasplantados pulmonares con serología citomegalovirus positiva pretrasplante. Mayores de 18 años. Que el tiempo previsto de profilaxis con valganciclovir sea de 6 meses posttrasplante. Pacientes que hayan otorgado su consentimiento informado por escrito. |
|
E.4 | Principal exclusion criteria |
HIV infected subjects. Pregnant and/or lactating women. Intolerance to Valganciclovir/Ganciclovir. Subjects unable to comply with the protocolo follow-up visits. Subjects who underwent multivisceral transplant. |
Pacientes infectados por VIH. Embarazadas y/o mujeres en período de lactancia. Intolerancia hacia el Valganciclovir/Ganciclovir. Pacientes que no puedan cumplir con el protocolo de seguimiento. Pacientes con trasplante multivisceral. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Cytomegalovirus disease incidence rate at 18 months after lung transplantation. |
Incidencia de enfermedad por citomegalovirus a los 18 meses del trasplante pulmonar. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
18 months after lung transplantation. |
A los 18 meses del trasplante pulmonar. |
|
E.5.2 | Secondary end point(s) |
Effectiveness endpoint: - Replication by cytomegalovirus incidence rate. Explanatory endpoints: - Demographic: age, gender and baseline disease. - Type of transplant: single or double lung transplant. - Before transplant cytomegalovirus serology. - HLA) typing for donor and recipient subjects. - Immunosuppressive induction treatment: dose and duration. - Immunosuppressive maintenance treatment: dose and duration. - Antiviral treatment against cytomegalovirus: dose and duration. - Other opportunistic infections not associated with cytomegalovirus: bacterial, viral and fungal. - Acute or chronic rejection of the transplant: time elapsed since the transplant, number of episodes and treatment. - Adverse events attributable to antiviral treatment against cytomegalovirus. Security Variables: - Incidence and severity of adverse events. |
Variables de eficacia: - Incidencia de replicación por citomegalovirus. Variables explicativas: - Demográficas: edad, sexo y enfermedad de base. - Tipo de trasplante: unipulmonar o bipulmonar. - Serología citomegalovirus pretrasplante. - Tipaje HLA donante y receptor. - Tratamiento Inmunosupresor de inducción: dosis y duración. - Tratamiento Inmunosupresor de mantenimiento: dosis y duración. - Tratamiento antiviral frente a citomegalovirus: dosis y duración. - Otras infecciones oportunistas no asociadas a citomegalovirus: bacterianas, víricas y fúngicas. - Rechazo agudo o crónico del injerto: tiempo trascurrido desde el trasplante, número de episodios y tratamiento. - Efectos adversos atribuibles al tratamiento antiviral frente a citomegalovirus. Variables de Seguridad: - Incidencia y severidad de los acontecimientos adversos. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
In every trial visit: Visit 1: within 30 days after lung transplantation. Visit 2: 30 days after lung transplantation. Visit 3: 60 days after lung transplantation. Visit 4: 90 days after lung transplantation. Visit 5: 120 days after lung transplantation. Visit 6: 150 days after lung transplantation. Visit 7: 180 days after lung transplantation. Visit 8: 210 days after lung transplantation. Visit 9: 240 days after lung transplantation. Visit 10: 270 days after lung transplantation. Visit 11: 300 days after lung transplantation. Visit 12: 330 days after lung transplantation. Visit 13: 360 days after lung transplantation. Visit 14: 450 days after lung transplantation. Visit 15: 540 days after lung transplantation. |
En cada visita del estudio Visita 1: dentro de los 30 días posteriores al trasplante pulmonar. Visita 2: 30 después del trasplante pulmonar. Visita 3: 60 después del trasplante pulmonar. Visita 4: 90 después del trasplante pulmonar. Visita 5: 120 después del trasplante pulmonar. Visita 6: 150 después del trasplante pulmonar. Visita 7: 180 después del trasplante pulmonar. Visita 8: 210 después del trasplante pulmonar. Visita 9: 240 después del trasplante pulmonar. Visita 10: 270 después del trasplante pulmonar. Visita 11: 300 después del trasplante pulmonar. Visita 12: 330 después del trasplante pulmonar. Visita 13: 360 después del trasplante pulmonar. Visita 14: 450 después del trasplante pulmonar. Visita 15: 540 después del trasplante pulmonar. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
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 | 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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
E.8.2.3.1 | Comparator description |
Terapia estándar |
Standard therapy |
|
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 7 |
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
|
Last visit of the last subject. |
Última visita del último paciente. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |