Clinical Trials Register

Summary
EudraCT Number:	2011-000836-27
Sponsor's Protocol Code Number:	AI444-026
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:	2011-09-23
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

2011-000836-27

A.3

Full title of the trial

An Open-Label Re-treatment Study with Peg-Interferon Alfa-2a, Ribavirin and BMS-790052 With or Without BMS-650032 for Subjects With Chronic Hepatitis C

Estudio abierto del retratamiento con peg-interferón alfa-2a, ribavirina y BMS 790052, con o sin BMS-650032, en sujetos con hepatitis C crónica

A.3.1

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

Study with PegInterferon Alfa-2a, Ribavirin and BMS-790052 with or without BMS-650032 for participants in some HCV trials

Estudio con PegInterferon Alfa-2a, Ribavirina y BMS-790052 con o sin BMS-650032 para participantes en algunos estudios de VHC

A.4.1

Sponsor's protocol code number

AI444-026

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	HCV NS5A Replication Co-Factor Inhibitor
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.3.9.2	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	30
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	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	HCV NS3 Protease Inhibitor
D.3.2	Product code	BMS-650032
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.3.9.2	Current sponsor code	BMS-650032
D.3.9.3	Other descriptive name	HCV NS3 Protease 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	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

HEPATITIS C VIRUS

Virus Hepatitis C

E.1.1.1

Medical condition in easily understood language

HEPATITIS C VIRUS

Virus Hepatitis C

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	14.0
E.1.2	Level	LLT
E.1.2	Classification code	10019752
E.1.2	Term	Hepatitis C virus (HCV)
E.1.2	System Organ Class	10022891 - Investigations

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 efficacy, as determined by the proportion of subjects with SVR24 for HCV genotype 1.

la eficacia, en su determinación mediante el porcentaje de sujetos con VHC de genotipo 1 con RVM24

E.2.2

Secondary objectives of the trial

? To assess efficacy, as determined by the proportion of subjects with SVR24 for HCV genotype 2, 3, and 4;
? To assess safety, as measured by the frequency of SAEs and discontinuations due to AEs for HCV genotypes 1 and 4 and separately for HCV genotypes 2 and 3;
? To assess efficacy, as determined by the proportion of subjects who achieve HCV RNA < LOQ (detectable or undetectable) at weeks: 1, 2, 4, 6, 8 and 12; Weeks 4 and 12 [VR (4&12)], EOT, or follow-up Week 12 for each HCV genotype;
? To assess efficacy, as determined by the proportion of subjects who achieve HCV RNA undetectable at weeks: 1, 2, 4, 6, 8 and 12; Weeks 4 and 12 (eRVR), EOT, or follow-up Week 12 (SVR12) for each HCV genotype;
? To describe drug-resistant variants associated with virologic failure for each HCV genotype.

See Protocol section 1.3.3 for additional exploratory objectives.

?Evaluar eficacia,en su determinación mediante porcentaje d sujetos con VHC d genotipo 2,3 y 4 con RVM24 ?Evaluar seguridad,en su determinación mediante la frecuencia d acontecimientos adversos graves y d abandonos por acontecimientos adversos en genotipos 1 y 4 y separadamente en genotipos 2 y 3 del VHC ?Evaluar eficacia,en su determinación mediante porcentaje d sujetos que alcancen un ARN del VHC < LDC(detectable o no detectable)en las Semanas:1, 2, 4, 6, 8 y 12; Semanas 4 y 12[RV (4 y 12)],FDT o en la Semana 12 de seguimiento en cada genotipo VHC ?Evaluar la eficacia,en su determinación mediante el porcentaje d sujetos que alcancen un ARN del VHC no detectable en las Semanas:1,2,4 ,6,8 y 12;Semanas 4 y 12 (RVRp),FDT o en Semana 12 del seguimiento(RVM12)en cada genotipo VHC ?Describir las variantes resistentes a la medicación asociadas al fracaso virológico en cada genotipo del VHC Vease sección protocol 1.3.3 para objetivos exploratorios adicionales

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

? Prior participation in any BMS-790052, BMS-650032, BMS-791325 trial and assigned to control arm (peginterferon?/ribavirin + placebo) during the trial.
? HCV genotype 1, 2, 3, or 4 (mixed genotypes are not permitted)
? HCV RNA viral load detectable

Haber participado en cualquier ensayo clínico con BMS-790052, BMS-650032 o BMS-791325, y haber sido asignados al grupo de control (pegIFN?/RBV + placebo) durante el ensayo ?Genotipos 1, 2, 3 o 4 del VHC (genotipos mixtos no estan permitidos) ?ARN del VHC detectable en la selección

E.4

Principal exclusion criteria

? Discontinuation from prior BMS HCV clinical trial due to a peginterferon/ribavirin-related event
? Any anti-HCV therapy following initial treatment with BMS-650032, BMS-790052 or BMS-791325;
? Positive for Hepatitis B infection (HBsAg) or HIV-1/HIV-2 antibody at screening;
? Evidence of medical condition associated with chronic liver disease other than HCV;
? Evidence of decompensated cirrhosis based on radiologic criteria or biopsy

?Abandono del estudio previo por acontecimiento adverso relacionado con pegIFN?/RBV; ?Sujetos que han recibido cualquier tratamiento para el VHC tras su tratamiento inicial con BMS-650032, BMS 790052 o BMS-791325; ?Positividad para HBsAg o anticuerpos frente a VIH-1/VIH-2 en la selección ?Evidencia de un proceso médico asociado a hepatopatía crónica distinto del VHC ?Evidencia de cirrosis descompensada basada en criterios radiológicos o resultados biópsicos

E.5 End points

E.5.1

Primary end point(s)

Proportion of subjects with SVR24 (undetectable HCV RNA at follow-up week 24) for all subjects infected with genotype 1.

Proporción de sujetos con RVM24, definida por un ARN del VHC no detectable en la Semana 24 de seguimiento, en todos los sujetos infectados por VHC de genotipo 1

E.5.1.1

Timepoint(s) of evaluation of this end point

Follow-up Week 24

Semana 24 de seguimiento

E.5.2

Secondary end point(s)

1) Proportion of subjects with SVR24 in genotype 2,3 &4
2) Safety measured by frequency of SAEs and discontinuations due to AEs
3)Efficacy based on HCV RNA values
4) Frequency of genotypic substitutions associated with virologic failure

1)Proporción de sujetos con RVM24 con genotipo 2,3 y4 2)Valoraciones de seguridad segun la frecuencia de SAE y discontinuaciones debido a acontecimientos adversos 3) Eficacia basaad en los valores de RNA 4) Frecuencia de sustitucio de genotipo asociado a con fallo virologico

E.5.2.1

Timepoint(s) of evaluation of this end point

1) Follow-up Week 24
2) Yearly and End of Trial
3) Weeks 1, 2, 4, 6, 8, 12, 24, followup week 12
4) End of Trial

1)Semana 24 de seguimiento 2) Frecuencia anual y final de estudio 3) Semanas 1,2,4,6,8,12,24, seguimiento semana24 4) Fin de estudio

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

Yes

E.6.11

Pharmacogenomic

Yes

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

HCV Resistance Testing; Exploratory Biomarker Assessments

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

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.8.3

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

Canada

Denmark

Egypt

France

Germany

Ireland

Israel

Italy

Mexico

Puerto Rico

Spain

Sweden

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

The last visit is defined as the follow-up week 48 visit. The end of the study is defined by when the last subject has completed the follow-up week 48 visit, was lost to follow-up, or discontinues from the study.

La visita final se define como la visita de seguimiento en semana 48. El final del estudio se define como la fecha en la que el ultimo paciente ha completado la visita de seguimiento de semana 48, se pierde su seguimiento o discontinua del estudio

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:

317

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

169

F.4.2.2

In the whole clinical trial

330

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 subjects/investigators unless the sponsor chooses to extend the study. The investigator should ensure that the subject receives appropriate standard of care to treat the condition under study.

Al final del estudio, el promotor no continuará proporcionando la medicación del estudio a los sujetos/investigadores a no ser que el promotor decida extender el estudio. El investigador debe asegurarse que el sujeto recibe el tratamiento estandar adecuado para el tratamiento de al 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

2011-11-18

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-11-11

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2014-09-23

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