Clinical Trials Register

Summary
EudraCT Number:	2011-004237-14
Sponsor's Protocol Code Number:	AI444-052
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:	2012-01-27
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

2011-004237-14

A.3

Full title of the trial

A Phase 3 Evaluation of BMS-790052 (Daclatasvir) Compared with Telaprevir in Combination with Peg-Interferon Alfa-2a and Ribavirin in Treatment-Naive Patients with Chronic Hepatitis-C

+ Pharmacogenetics Blood Sample Amendment 01 (version 1.0 dated
23-Nov-11)

Estudio fase 3 de BMS-790052 (daclatasvir) comparado con telaprevir en combinación con peginterferón alfa-2a y ribavirina en pacientes con hepatitis C crónica que no han recibido tratamiento con anterioridad.

Enmienda 1 de muestra de sangre para farmacogenética (version 1.0 de fecha 23-nov-11)

A.3.1

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

Study comparing BMS-790052 (daclatasvir) to telaprevir combined with peginterferon-alfa-2a and ribavirin in untreated hepatitis C patients

Estudio comparativo de BMS-790052 (daclatasvir) con telaprevir en combinación con peginterferón alfa-2a y ribavirina en pacientes con hepatitis C crónica que no han recibido tratamiento con anterioridad.

A.3.2

Name or abbreviated title of the trial where available

COMMAND-3

Comando-3

A.4.1

Sponsor's protocol code number

AI444-052

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT01492426

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	Bristol-Myers Squibb International Corporation
B.1.3.4	Country	Belgium
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	Bristol-Myers Squibb International Corporation
B.4.2	Country	Belgium
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Bristol-Myers Squibb International Corporation
B.5.2	Functional name of contact point	EU Study Start-Up Unit
B.5.3	Address:
B.5.3.1	Street Address	Parc de l'Alliance - Avenue de Finlande, 8
B.5.3.2	Town/ city	Braine-l'Alleud
B.5.3.3	Post code	1420
B.5.3.4	Country	Belgium
B.5.6	E-mail	clinical.trials@bms.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	BMS-790052
D.3.2	Product code	BMS-790052
D.3.4	Pharmaceutical form	Film-coated 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	daclatasvir
D.3.9.2	Current sponsor code	BMS-790052
D.3.9.3	Other descriptive name	HCV NS5A Replication Co-Factor Inhibitor
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	60
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	Incivo
D.2.1.1.2	Name of the Marketing Authorisation holder	Janssen Cilag International NV
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Film-coated 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.3.9.1	CAS number	402957-28-2
D.3.9.3	Other descriptive name	TELAPREVIR
D.3.9.4	EV Substance Code	SUB31651
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	375
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

Chronic Hepatitis C

Hepatitis C Crónica

E.1.1.1

Medical condition in easily understood language

Chronic Hepatitis C

Hepatitis C Crónica

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 compare rates of SVR12, defined as HCV RNA < LOQ (detectable or undetectable) at follow-up Week 12, for genotype 1 patients treated with either BMS-790052 or TVR in combination with pegIFN?-2a/RBV

Comparar las tasas de RVS12, definida como ARN del VHC < LDC (detectable o indetectable) en la semana 12 de seguimiento, para pacientes de genotipo 1 tratados con BMS-790052 o TVR en combinación con pegIFN-2a/RBV

E.2.2

Secondary objectives of the trial

To compare the proportion of patients with :
? hemoglobin laboratory value < 10 g/dL during the first 12 weeks of treatment;
? rash-related dermatologic ?events of special interest? reported during the first 12 weeks of treatment;
? HCV RNA undetectable at Week 12;
? HCV RNA undetectable at Week 4;
? HCV RNA undetectable at Weeks 4 and 12;
? SVR24, defined as HCV RNA < LOQ (detectable or undetectable) at follow-up Week 24;
? SVR12 by IL28B rs12979860 SNP genotype.

Comparar el porcentaje de pacientes con concentraciones de hemoglobina < 10 g/dl durante las primeras 12 semanas de tratamiento;
Comparar el porcentaje de pacientes con ?acontecimientos de especial interés? (AEI) dermatológicos asociados a exantema notificados durante las primeras 12 semanas de tratamiento;
Comparar el porcentaje de pacientes con ARN del VHC indetectable en la semana 12; Comparar el porcentaje de pacientes con ARN del VHC indetectable en la semana 4; Comparar el porcentaje de pacientes con ARN del VHC indetectable en las semanas 4 y 12;
Comparar el porcentaje de pacientes con RVS24, definida como ARN del VHC < LDC (detectable o indetectable) en la semana 24 de seguimiento;
Comparar el porcentaje de pacientes con RVS12 según el genotipo del SNP rs12979860 en el gen IL28B.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Subjects chronically infected with HCV genotype 1
- HCV RNA viral load ? 10,000 IU/mL
- No prior treatment including but not limited to interferon, ribavirin and direct-acting antivirals
- if no prior history of cirrhosis liver biopsy within 3 years or Fibroscan® within 1 year
- Body Mass Index (BMI) of 18 to 35 kg/m²
- Negative for HIV and Hepatitis B

-Sujetos infectados crónicamente por el genotipo 1 del VHC ;
-ARN del VHC >= 10,000 IU/ml
-No existe ningún tratamiento previo incluido y no limitado al tratamiento con interferón, ribavirina y antivirales de acción directa
-Si no hay antecedentes de cirrosis, la biopsia hepática a menos de 3 años o Fibroscan ® a menos de 1 año
-Índice de Masa Corporal (IMC) de 18 a 35 kg / m²
-Seronegatividad para el VIH y el HBsAg

E.4

Principal exclusion criteria

- Evidence of decompensated liver disease
- Evidence of medical condition contributing to chronic liver disease other than HCV

-Evidencia de enfermedad hepática descompensada
-Evidencia de un trastorno médico que contribuya a la hepatopatía crónica, distinto del VHC

E.5 End points

E.5.1

Primary end point(s)

Proportion of patients with SVR12, defined as HCV RNA less than limit of quantitation at follow-up Week 12 in each group

Porcentaje de pacientes con RVS12, definida como ARN del VHC < LDC en la semana 12 de seguimiento para cada cohorte.

E.5.1.1

Timepoint(s) of evaluation of this end point

Follow-up Week 12

Semana 12 de seguimiento

E.5.2

Secondary end point(s)

Proportion of patients with
1) hemoglobin value less than 10 g/dL
2) rash events
3) HCV RNA undetectable Week 12
4) HCV RNA undetectable Week 4
5) HCV RNA undetectable Weeks 4 and 12
6) SVR24
7) SVR12 based on IL28B genotype

Porcentaje de pacientes con
1) la hemoglobina valor inferior a 10 g / dl
2) ?acontecimientos de especial interés? dermatológicos asociados a exantema
3) ARN del VHC indetectable en la semana 12
4) ARN del VHC indetectable en la semana 4
5) ARN del VHC indetectable en las semanas 4 y 12
6) RVS24
7) RVS12 según el genotipo IL28B

E.5.2.1

Timepoint(s) of evaluation of this end point

1) Up to Week 12
2) Up to Week 12
3) Week 12
4) Week 4
5) Week 4 and 12
6) Follow-up Week 24
7) Follow-up Week 12

1) Hasta la semana 12
2) Hasta la semana 12
3) Semana 12
4) Semana 4
5) Semana 4 y 12
6) Seguimiento en la semana 24
7) Seguimiento en la semana 12

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

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

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

Biomarker Assessments; Virologic Resistance Testing; Serum IP-10 Assessment and Healthcare Resource Utilization Assessment

Evaluaciones de biomarcadores; Pruebas de resistencia virológica, Evaluación de suero IP-10 y Evaluacion de la utilización de recursos sanitarios

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

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

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)

Yes

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

Brazil

Canada

Denmark

France

Germany

Israel

Italy

Poland

Russian Federation

Spain

Switzerland

United Kingdom

United States

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

LPLV

Ultima visita del ultimo paciente

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:

810

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

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

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.4.2

For a multinational trial

F.4.2.1

In the EEA

485

F.4.2.2

In the whole clinical trial

900

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)

At the end of the study, the sponsor will not continue to supply study drug to patients/investigators unless the sponsor chooses to extend the study. The investigator should ensure that the patient receives appropriate standard of care to treat the condition under study.

Al final del estudio, el promotor no seguirá suministrando el medicamento del estudio a los pacientes / investigadores a menos que el promotor decida ampliar el estudio. El investigador debe asegurarse que el paciente reciba la práctica clínica habitual para el tratamiento de la enfermedad en estudio

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

2012-03-21

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-03-14

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

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