Clinical Trials Register

Summary
EudraCT Number:	2012-000515-80
Sponsor's Protocol Code Number:	RIFA-AAH
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2012-06-26
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2012-000515-80

A.3

Full title of the trial

Effects of rifaximin administration in patients with severe acute alcoholic hepatitis. Comparative pilot study.

Efectos de la administración de rifaximina en pacientes con hepatitis alcohólica aguda grave. Estudio piloto comparativo

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Effects of rifaximin administration in patients with severe acute alcoholic hepatitis. Comparative pilot study.

Efectos de la administración de rifaximina en pacientes con hepatitis alcohólica aguda grave. Estudio piloto comparativo

A.4.1

Sponsor's protocol code number

RIFA-AAH

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Juan Córdoba
B.1.3.4	Country	Spain
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Joan Córdoba
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Juan Córdoba
B.5.2	Functional name of contact point	Sponsor and coordinator
B.5.3	Address:
B.5.3.1	Street Address	Paseo Vall d'Hebron 119-129. Hospital Universitari Vall d'Hebron
B.5.3.2	Town/ city	Barcelona
B.5.3.3	Post code	08035
B.5.3.4	Country	Spain
B.5.4	Telephone number	+34932746140
B.5.5	Fax number	+34934894102
B.5.6	E-mail	jcordoba@vhebron.net

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	SPIRAXIN
D.2.1.1.2	Name of the Marketing Authorisation holder	ALFA WASSERMANN, S.p.A.
D.2.1.2	Country which granted the Marketing Authorisation	Spain
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	RIFAXIMIN
D.3.9.1	CAS number	80621-81-4
D.3.9.4	EV Substance Code	SUB10312MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	200
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

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

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

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

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

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)

E.8.2.2

Placebo

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

E.8.3

The trial involves single site in the Member State concerned

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

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

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

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

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

expected normal treatment of that condition

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2012-08-29

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-05-17

P. End of Trial
P.	End of Trial Status	Completed

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