Clinical Trials Register

Summary
EudraCT Number:	2011-006131-38
Sponsor's Protocol Code Number:	CDEB025A2312
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:	2012-04-12
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

2011-006131-38

A.3

Full title of the trial

A multi-centre 3-year follow-up study to assess the durability of sustained virologic response in alisporivir treated chronic hepatitis C patients

Estudio de seguimiento a 3 años, multicéntrico, para evaluar la durabilidad de la respuesta virológica sostenida en pacientes con Hepatitis C crónica tratados con Alisporivir

A.3.1

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

A 3-year follow-up study of chronic hepatitis C patients treated with alisporivir to assess durability of sustained virologic response

Estudio de seguimiento a 3 años en pacientes con Hepatitis C crónica tratados con Alisporivir para evaluar la durabilidad de la respuesta virológica sostenida

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

CDEB025A2312

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	Novartis Farmaceutica, S.A.
B.1.3.4	Country	Spain
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Novartis Pharma Services AG
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Novartis Farmaceutica, S.A.
B.5.2	Functional name of contact point	Inma Bosch
B.5.3	Address:
B.5.3.1	Street Address	Gran Via Corts Catalanes, 764
B.5.3.2	Town/ city	Barcelona
B.5.3.3	Post code	08013
B.5.3.4	Country	Spain
B.5.4	Telephone number	+34933064200
B.5.5	Fax number	+34933064290
B.5.6	E-mail	eecc.novartis@novartis.com

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	No
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.3.1	Product name	Alisporivir
D.3.2	Product code	DEB025
D.3.4	Pharmaceutical form	Capsule, soft
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.3.9.1	CAS number	254435-95-5
D.3.9.3	Other descriptive name	ALISPORIVIR
D.3.9.4	EV Substance Code	SUB33108
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.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
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	PEGASYS, 180 microgramos, solución inyectable en jeringa precargada
D.2.1.1.2	Name of the Marketing Authorisation holder	ROCHE REGISTRATION LIMITED
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.3.1	Product name	PEGINTERFERON ALFA
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PEGINTERFERON ALFA-2A
D.3.9.1	CAS number	198153-51-4
D.3.9.2	Current sponsor code	ROCHE
D.3.9.4	EV Substance Code	SUB16452MIG
D.3.10	Strength
D.3.10.1	Concentration unit	µl/ml microlitre(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	180
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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	Yes
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	Yes
D.3.11.13.1	Other medicinal product type	Es conjugado covalente de la proteína interferón alfa-2a obtenido mediante tecnología del ADN recombinante de Escherichia Coli con bis # [monometoxipolietilenglicol].
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Comparator
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	COPEGUS 200 mg comprimidos recubiertos con película
D.2.1.1.2	Name of the Marketing Authorisation holder	ROCHE PHARMA, S.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.3.1	Product name	RIBAVIRINA
D.3.4	Pharmaceutical form	Gastro-resistant 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	RIBAVIRIN
D.3.9.1	CAS number	36791-04-5
D.3.9.2	Current sponsor code	ROCHE FARMA
D.3.9.4	EV Substance Code	SUB10297MIG
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule, soft
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Chronic hepatitis C in patients who achieved sustained virologic response (SVR24) on alisporivir in a Novartis-sponsored chronic Hepatitis C study.

Hepatitis C crónica en pacientes que hayan alcanzado una respuesta virológica sostenida (RVS24) tratados con alisporivir en un estudio de Hepatitis C crónica patrocinado por Novartis

E.1.1.1

Medical condition in easily understood language

Chronic hepatitis C in patients who achieved sustained virologic response on alisporivir in a previous Novartis-sponsored trial.

Hepatitis C crónica en pacientes que hayan alcanzado una respuesta virológica sostenida con alisporivir en un estudio previo patrocinado por Novartis

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	10008912
E.1.2	Term	Chronic hepatitis C
E.1.2	System Organ Class	10021881 - Infections and infestations

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 assess the durability of sustained virologic response after SVR24 has been achieved in patients treated with alisporivir in a Novartis-sponsored chronic Hepatitis C study.

Evaluar la durabilidad de la respuesta virológica sostenida después de que se haya alcanzado la RVS24 en pacientes tratados con alisporivir en un estudio en Hepatitis C crónica patrocinado por Novartis

E.2.2

Secondary objectives of the trial

-To determine whether subsequent detection of HCV RNA in patients who relapse following SVR24, represents the re-emergence of pre-existing virus, the development of resistance mutations, or whether it is due to re-infection.
-To assess the impact of successful alisporivir treatment on the change in liver disease over time and to assess the development of hepatocellular carcinoma (HCC).
-To assess the safety over time of previous alisporivir exposure.

? Determinar si la posterior detección de ARN del VHC en pacientes que presenten recidiva tras la RVS24, representa la reaparición del virus preexistente, el desarrollo de mutaciones de resistencia o si se debe a una reinfección
? Evaluar el impacto del tratamiento satisfactorio con alisporivir en el cambio de la enfermedad hepática con el tiempo
? Evaluar el desarrollo de carcinoma hepatocelular (CHC)
? Evaluar la seguridad con el tiempo de la exposición previa a alisporivir

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

-Written informed consent must be obtained before any assessment is performed
-Males or females must be aged 18 years or older
-Have previously completed a Novartis-sponsored hepatitis C study and received alisporivir
-Have achieved SVR24
-Be able to comply with visit schedule

? Debe obtenerse el consentimiento informado por escrito antes de que se realice ninguna evaluación.
? Hombres y mujeres ?18 años de edad
? Que hayan finalizado previamente un estudio en hepatitis C patrocinado por Novartis y hayan recibido alisporivir
? Que hayan alcanzado RVS24
? Que sean capaces de cumplir el programa de visitas

E.4

Principal exclusion criteria

-Use of any investigational drugs within 5 half-lives of enrollment, or within 30 days of that medication, whichever is longer
-Use or planned use to start a new course of hepatitis C therapy

1. Uso de cualquier fármaco en investigación en 5 semividas desde el reclutamiento o en 30 días desde esa medicación, lo que sea más largo.
2. Uso o uso planificado para comenzar un nuevo ciclo de terapia para la hepatitis C

E.5 End points

E.5.1

Primary end point(s)

To examine the proportion of patients who maintain HCV RNA viral load below lower limit of quantification (LOQ) at each scheduled time point.

Examinar la proporción de pacientes que mantienen la carga viral de ARN del VHC por debajo del límite cuantificación (LC) en cada visita del estudio

E.5.1.1

Timepoint(s) of evaluation of this end point

During the 5 scheduled visits within three years.

Durante las 5 visitas del estudio en 3 años.

E.5.2

Secondary end point(s)

-HCV RNA viral load
-The proportion of patients who normalize alanine aminotransferase (ALT)
-Liver fibrosis evaluations using Fibrotest and elastography, and to monitor for any changes over time using ultrasound of the liver and spleen
-The proportion of relapsed patients
-The proportion of re-infected patients
-The safety assessment will be based on the analyses of adverse events, vital signs and laboratory evaluations.

? Carga viral de ARN del VHC
? Proporción de pacientes que normalizan los niveles de alanina aminotransferasa (ALT)
? Las evaluaciones de la fibrosis hepática se realizarán utilizando FibroTest® y elastografía, y para monitorizar cualquier cambio con el tiempo se realizará ecografia en hígado y bazo.
? Proporción de pacientes con recidiva
? Proporción de pacientes con reinfeccion
? La evaluación de seguridad se basará en el analisis de los efectos adversos, los signos vitales y las evaluaciones de laboratorio.

E.5.2.1

Timepoint(s) of evaluation of this end point

During the 5 scheduled visits within three years.

Durante las 5 visitas del estudio en 3 años.

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

Yes

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

Yes

E.6.13.1

Other scope of the trial description

To assess the durability of sustained virologic response in alisporivir-treated chronic hepatitis C patients by assessing HCV RNA levels at scheduled visits.

Evaluar la durabilidad de la respuesta virológica sostenida en pacientes con Hepatitis C crónica tratados con alisporivir mediante la detección de ARN del VHC en las visitas del estudio.

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)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

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

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

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

Yes

E.8.5.1

Number of sites anticipated in the EEA

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

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

Argentina

Australia

Austria

Belgium

Brazil

Bulgaria

Canada

Egypt

France

Germany

Hong Kong

Hungary

India

Israel

Italy

Korea, Republic of

Mexico

Philippines

Poland

Romania

Russian Federation

Spain

Taiwan

Thailand

Turkey

United Kingdom

United States

Vietnam

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 consented patient.

Ultima visita del ultimo paciente que hay firmado el consentimiento informado.

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:

2000

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

200

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

Yes

F.3.3.1

Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2012-04-12.

Yes

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

Yes

F.3.3.4

Nursing women

Yes

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.4.2

For a multinational trial

F.4.2.2

In the whole clinical trial

2000

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)

None. This study involves routine follow-up tests with blood samplings at each scheduled visit. No treatment is involved.

Ninguno. Este estudio supone visitas de seguimiento de rutina con extracción de muestras de sangre en cada visita. No hay tratamiento.

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2012-05-18

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-05-09

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2015-05-21

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