E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute alcoholic hepatitis |
Hepatitis alcohólica aguda |
|
E.1.1.1 | Medical condition in easily understood language |
Acute alcoholic hepatitis |
Hepatitis alcohólica aguda |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
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 | 10000649 |
E.1.2 | Term | Acute alcoholic hepatitis |
E.1.2 | System Organ Class | 10019805 - Hepatobiliary disorders |
|
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 investigate whether the administration of rifaximin as an adjunct to corticosteroids decreases the number of bacterial infections in patients 90 days with acute alcoholic hepatitis. |
Investigar si la administración de rifaximina como tratamiento adyuvante a los corticoides disminuye el número de infecciones bacterianas a 90 días en pacientes con hepatitis alcohólica aguda. |
|
E.2.2 | Secondary objectives of the trial |
- Effect of rifaximin in the response to corticosteroids after 7 days - Serum levels of endotoxemia and proinflammatory cytokines and chemotactic (chemokines) - Type of infections developed within the hospital, 30 and 90 days - Frequency and type of other complications of liver failure |
- Efecto de la rifaximina en la respuesta a corticoides a los 7 días - Niveles séricos de endotoxemia y citoquinas proinflamatorias y quimiotácticas (quimiocinas) - Tipo de infecciones desarrolladas dentro de la hospitalización, a los 30 y a los 90 días - Frecuencia y tipo de otras complicaciones de la insuficiencia hepática |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patients> 18 and <70 years of age. - Excessive alcohol consumption prior to admission. - Jaundice in the last 3 months. - Modified Maddrey index> 32. - Confirmation of acute alcoholic hepatitis histology defined in the protocol |
- Pacientes >18 y < 70 años de edad. - Consumo excesivo de alcohol previo al ingreso. - Ictericia en los últimos 3 meses. - Índice de Maddrey modificado >32. - Confirmación histológica de hepatitis alcohólica aguda definida en el protocolo |
|
E.4 | Principal exclusion criteria |
- Advanced or terminal chronic illness - Hepatocarcinoma - Complete portal thrombosis. - Autoimmune liver disease. - Infection with hepatitis B and C, or HIV. - Use of rifaximin in the last 2 months. |
- Enfermedad crónica evolucionada o terminal - Hepatocarcinoma - Trombosis portal completa. - Enfermedad hepática autoinmune. - Infección por virus de la hepatitis B y C, o VIH. - Uso de rifaximina en los últimos 2 meses. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
bacterial infections |
infecciones bacterianas |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
During hospitalization, 30 and 90 days |
Durante el ingreso hospitalario, 30 y 90 días |
|
E.5.2 | Secondary end point(s) |
response to specific treatment and complications |
respuesta al tratamiento específico y complicaciones |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
at 7 days, and during hospitalization, 30 and 90 days |
a los 7 días; y durante el ingreso hospitalario, 30 y 90 días |
|
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 | 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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
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 | Yes |
E.8.1.7.1 | Other trial design description |
cohorte histórica |
historical cohort |
|
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 |
cohorte histórica |
historical cohort |
|
E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 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 undergoing the trial |
|
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 | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |