E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Hepatitis B re-infección Hepatitis B re-infection |
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E.1.1.1 | Medical condition in easily understood language |
Recurrencia de una infección de la hepatitis B Hepatitis B infection re-occurence |
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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 | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10058827 |
E.1.2 | Term | Hepatitis B reactivation |
E.1.2 | System Organ Class | 100000004862 |
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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 |
Investigar la eficacia de Zutectra en pacientes que se han sometido a un trasplante ortotópico de hígado
To investigate the efficacy of Zutectra in orthotopic liver transplanted patients |
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E.2.2 | Secondary objectives of the trial |
Demostrar la seguridad de Zutectra en pacientes que se han sometido a un trasplante de hígado ortotópico
To demonstrate safety of Zutectra in orthotopic liver transplanted patients
Evaluar el número de reinfecciones del hígado por el virus de la hepatitis B (resultado positivo para HBsAg y síntomas clínicos).
To assess the number of Hepatitis B virus re-infections of the liver (HBsAg positive and clinical symptoms) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Obtención del consentimiento informado por escrito antes del trasplante ortotópico de hígado (TOH), como máximo 3 meses antes de dicho TOH 1. Written informed consent obtained prior to orthotopic liver transplantation (OLT) - not more than 3 months before OLT 2.Pruebas históricas en las 4 semanas anteriores de que el ADN del VHB es indetectable en el momento de la firma del consentimiento informado 2.Historical evidence within the last 4 weeks that HBV-DNA is undetectable at time point of signature of Informed Consent 3.Pacientes varones y mujeres (con edades comprendidas entre los 18 y los 75 años) 3. Male and female patients (age 18-75 years) 4.Pacientes con diagnóstico de insuficiencia hepática con infección de hepatitis B 4. Patients with the diagnosis of liver failure with hepatitis B infection 5.Pacientes que se someten a trasplante o retrasplante de hígado 5. Patients undergoing liver transplantation or re-transplantation 6.Resultado negativo para el HBsAg los días 7 o 14 después del TOH 6. HBsAg negative on day 7 or on day 14 after OLT 7.ADN del VHB indetectable en el momento del TOH 7. HBV-DNA undetectable at OLT 8.Concentración sérica de anticuerpos contra HBs los días 7 o 14 después del trasplante ? 400 UI/l 8. Serum HBs antibody concentration on day 7 or on day 14 after OLT ? 400 IU/l 9.Paciente estable en un estado general que, en opinión del investigador, permite su participación segura en el estudio 9. Stable patient in a condition which in the opinion of the investigator would permit safe participation in the study 10.Disposición para rellenar el diario del paciente 10. Willingness to fill out patient diary |
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E.4 | Principal exclusion criteria |
1.Retrasplante debido a recurrencia viral 1. Re-transplantation due to viral recurrence 2.Resultado positivo en la prueba del VIH o del VHC en el momento del trasplante 2. Positive HIV or HCV test at time of transplantation 3. ADN del VHB positivo en el momento del TOH 3. HBV-DNA positive at OLT 4.Pacientes que hayan recibido órganos de donantes positivos para HBsAg 4. Patients having received organs from HBsAg positive donors 5.Embarazo o medidas anticonceptivas poco fiables, o mujer en período de lactancia (exclusivamente en mujeres) 5. Pregnancy or unreliable contraceptive measures or lactation period (females only) 6.Intolerancia conocida a las inmunoglobulinas o sustancias comparables (por ejemplo, reacción a la vacunación) 6. Known intolerance to immunoglobulins or comparable substances (e.g. vaccination reaction) 7.Intolerancia conocida a proteínas de origen humano 7. Known intolerance to proteins of human origin 8.Participación en otro ensayo clínico de intervención en los 90 días anteriores a la incorporación al estudio o durante el estudio, o participación anterior en este estudio (a excepción de los fallos de selección) 8. Participation in another interventional clinical trial within 90 days before entering the study or during the study and/or previous participation in this study except screening failures 9.Sospecha de alcoholismo o drogadicción 9. Suspicion of drug and/or alcohol abuse 10.Incapacidad o falta de motivación para participar en el estudio 10. Inability or lacking motivation to participate in the study 11.Empleado o familiar directo de un empleado de la OIC, del centro del estudio o Biotest 11. Employee or direct relative of an employee of the CRO, the study site, or Biotest |
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E.5 End points |
E.5.1 | Primary end point(s) |
La tasa de fracaso después de 24 semanas de tratamiento basándose en unas concentraciones mínimas séricas de anti-HBs ? 100 UI/l y el número de reinfecciones relacionadas con la hepatitis B en pacientes con concentraciones séricas mínimas de anti-HBs > 100 UI/l.
The failure rate after 24 weeks of treatment based on the trough levels of serum anti-HBs ? 100 IU/l and the number of hepatitis B related re-infections in patients with trough levels of serum anti-HBs > 100 IU/l. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Al final del tratamiento en la semana 24 o en caso de una recurrencia de la infección
End of 24 weeks of treatment, or at a re-occurence of infection. |
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E.5.2 | Secondary end point(s) |
Eficacia- Se evaluará el número total de pacientes con infecciones relacionadas con la hepatitis B mediante la monitorización de los signos clínicos, la función hepática y la medición de HBsAg y ADN del VHB. Efficacy - The number of all patients with hepatitis B related infections will be assessed by monitoring of clinical signs, liver function and measurement of HBsAg and HBV-DNA. Eficacia: Concentraciones séricas de anti-HBs Seguridad:Perfil de los acontecimientos adversos, hematología, química clínica y análisis de orina Efficacy - serum anti-HBs concentrations Safety - Adverse Event profile, heamatology, clinical chemistry and urinalysis |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Acontecimientos adversos-cada visita serología de la hepatitis- semanal durante las primeras 8 semanas, después cada mes hasta la semana 24.
Adverse Events - each visit Hepatitis serology - weekly for the first 8 weeks, then monthly until week 24. |
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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 | 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 | No |
E.8.1.1 | Randomised | No |
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 | 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
| 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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 10 |
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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Last visit of the last subject - última visita del último paciente |
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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 | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |