Clinical Trials Register

Summary
EudraCT Number:	2011-004928-35
Sponsor's Protocol Code Number:	VX-950HPC3008
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

2011-004928-35

A.3

Full title of the trial

Open-Label, Phase 3b Study to Determine Efficacy and Safety of Telaprevir, Pegylated-Interferon-alfa-2a and Ribavirin in Hepatitis C Virus Treatment-Naïve and Treatment-Experienced Subjects with Genotype 1 Chronic Hepatitis C and Human Immunodeficiency Virus Type 1 (HCV-1/HIV-1) Coinfection

Estudio en fase 3b abierto para determinar la eficacia y la seguridad de telaprevir, interferón-alfa-2a pegilado y ribavirina en sujetos con coinfección por el virus de la hepatitis C crónica de genotipo 1 y el virus de la inmunodeficiencia humana de tipo 1 (VHC-1/VIH-1), con y sin tratamiento previo para el virus de la hepatitis C

A.3.1

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

An Efficacy and Safety Study of Telaprevir in Patients Infected With Both Chronic HCV-1 and HIV-1

Estudio de Eficacia y seguridad de telaprevir en pacientes infectados con VHC-1 Crónica y VHI-1

A.3.2

Name or abbreviated title of the trial where available

INSIGHT

A.4.1

Sponsor's protocol code number

VX-950HPC3008

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	Janssen-Cilag International NV
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	Janssen-Cilag International NV
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	Janssen-Cilag International NV - Clinical Registry Group
B.5.2	Functional name of contact point	Janssen Biologics BV
B.5.3	Address:
B.5.3.1	Street Address	Archimedesweg 29
B.5.3.2	Town/ city	Leiden
B.5.3.3	Post code	2333CM
B.5.3.4	Country	Netherlands
B.5.4	Telephone number	+31071524 21 66
B.5.5	Fax number	+31071524 21 10
B.5.6	E-mail	ClinicalTrialsEU@its.jnj.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	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.3.1	Product name	INCIVO
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 infection

Infeccion Crónica por Hepatitis C

E.1.1.1

Medical condition in easily understood language

Chronic hepatitis C infection

Infeccion Crónica por 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	14.1
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

The primary objective is to assess the antiviral efficacy of telaprevir, Peg-IFN-alfa-2a, and RBV in HCV-1/HIV-1 coinfected subjects as measured by sustained virologic response (SVR12planned). SVR12planned is defined as having an undetectable HCV RNA level 12 weeks after the last planned dose of study medication.

El objetivo principal es evaluar la eficacia antiviral de telaprevir, interferón alfa-2a pegilado (Peg-IFN-alfa-2a) y ribavirina (RBV) en sujetos coinfectados por el VHC-1/VIH-1 determinada por la respuesta virológica sostenida (RVS12prevista). La RVS12prevista se define como una concentración indetectable de ácido ribonucleico (ARN) del VHC 12 semanas después de la última dosis prevista de la medicación del estudio.

E.2.2

Secondary objectives of the trial

Reference is made to section 2.1 (p.35-36) of the Clinical Trial Protocol.

Se hace referencia a la sección 2.1 (p. 39) del Protocolo de ensayo clínico.

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

A substudy of VX-950HPC3008 to evaluate the intensive steady-state pharmacokinetic profile of telaprevir and selected antiretrovirals

Subestudio de VX-950HPC3008 para evaluar el perfil farmacocinético intensivo en estado de equilibrio del telaprevir y de determinados antirretrovirales.

E.3

Principal inclusion criteria

- HCV RNA more than 6 months prior screening or histological diagnosis based on liver biopsy or fibroscan) HCV infection genotype 1 with HCV RNA level > 1,000 IU/mL.
- Confirmed diagnosis of HIV-1 infection >6 months before the screening visit.
- CD4 count >300 cells/mm3 at screening and no value <200 cells/mm3 within 6 months of screening visit.
- HIV-1 RNA undetectable by an ultrasensitive assay at least once within 90 days of the screening visit.
- No HIV RNA values >200 copies/mL within 6 months of the screening visit.
- HIV-1 RNA <50 copies/mL by Roche Taqman HIV-1 RNA v2 at screening.

-ARN del VHC de más de 6 meses antes de la selección o diagnóstico histológico basado en biopsia hepática o fibroscan. Infección por VHC genotipo 1 con ARN del VHC > 1,000 IU/mL.
-Diagnóstico confirmado de infección por VIH-1 más de 6 meses antes de la visita de selección
-Recuento de CD4> 300 células/mm3 en la selección y no tener ningún valor <200 cells/mm3 en los 6 meses anteriores a la selección.
-ARN del VIH-1 indetectables mediante un análisis ultrasensible al menos una vez en los 90 días previos a la visita de selección
-No valores de ARN del VIH > 200 copias/ml en los 6 meses previos a la visita de selección.
- ARN VIH-1 <50 copias / mL por Roche TaqMan ARN VIH-1 v2 en l a selección

E.4

Principal exclusion criteria

- Anticipated need to switch HAART regimens from screening through the Telaprevir treatment period
- Infection or co-infection with HCV other than genotype 1
- Contraindication to the administration of Peg-IFN-alfa or RBV
- Hepatitis B virus (HBV) co-infection
- Acute or active condition of HIV-associated opportunistic infection within 6 months of screening
- Pre-existing psychiatric condition
- Evidence of hepatic decompensation.

-Necesidad prevista de cambiar los regímenes de TARGA desde la selección y durante todo el periodo de tratamiento con Telaprevir.
-La infección o coinfección con VHC de genotipo distinto a genotipo 1.
-Contraindicacion a la administración del Peg-IFN-alfa o RBV
-Coinfección con Hepatitis B (VHB).
-Infección oportunista relacionada con el VIH aguda o activa en los 6 meses previos a la selección
-condición psiquiátrica pre-existente.
- La evidencia de descompensación hepática.

E.5 End points

E.5.1

Primary end point(s)

Proportion of patients achieving undetectable plasma HCV ribonucleic acid (RNA) levels

Proporción de pacientes que alcanzaron los niveles indectables en plasma de ácido ribonucleico (ARN) del VHC

E.5.1.1

Timepoint(s) of evaluation of this end point

12 weeks after the last planned dose of study drug

12 semanas después de la última dosis del fármaco prevista del estudio

E.5.2

Secondary end point(s)

- Proportion of patients achieving undetectable plasma HCV ribonucleic acid (RNA) levels
- Proportion of patients achieving undetectable plasma HCV ribonucleic acid (RNA) levels
- Proportion of patients achieving undetectable plasma HCV ribonucleic acid (RNA) levels
- Proportion of patients achieving undetectable plasma HCV ribonucleic acid (RNA) levels
- Proportion of patients achieving undetectable plasma HCV ribonucleic acid (RNA) levels
- Proportion of patients achieving undetectable plasma HCV ribonucleic acid (RNA) levels
- Proportion of patients having confirmed detectable HCV ribonucleic acid (RNA levels)
- Proportion of patients having an increase > 1 log in HCV RNA level from the lowest level reached, or a value of HCV RNA > 100 IU/mL in subjects whose HCV RNA has previously become < 25 IU/mL during treatment
- Evaluate safety and tolerability of telaprevir in combination with Peg-IFN-alfa-2a and RBV and permitted HIV ARVs as assessed by AEs

- Proporción de pacientes que alcanzaron los niveles indetectables en plasma de ácido ribonucleico (ARN) de VHC
- Proporción de pacientes que alcanzaron los niveles indetectables en plasma de ácido ribonucleico (ARN) de VHC
- Proporción de pacientes que alcanzaron los niveles indetectables en plasma de ácido ribonucleico (ARN) de VHC
- Proporción de pacientes que alcanzaron los niveles indetectables en plasma de ácido ribonucleico (ARN) de VHC
- Proporción de pacientes que alcanzaron los niveles indetectables en plasma de ácido ribonucleico (ARN) de VHC
-Proporción de pacientes que han confirmado ácido ribonucleico del VHC (niveles de ARN) detectable.
-Proporción de pacientes que han tenido un aumento > 1 log en el nivel de ARN del VHC desde el nivel más bajo alcanzado, o un valor de ARN del VHC> 100 UI /ml en pacientes cuyo valor de ARN del VHC había alcanzado previamente < 25 IU/mL durante el tratamiento.

-Evaluar la seguridad y la tolerabilidad de telaprevir en combinación con Peg-IFN-alfa-2a and RBV y los ARV de VIH permitidos mediante la valoración de los EAs.

E.5.2.1

Timepoint(s) of evaluation of this end point

- 24 weeks after last planned dose of study drug
- week 4 of study drug
- week 12 of study drug
- week 4 and week 12 of study drug
- actual end of study drug (week 24, week 48 or early discontinuation)
- planned end of study drug (week 24 or week 48)
- follow-up period after previous undetectable HCV RNA levels at actual end of study drugs (week 24 or 48 or early discontinuation)
- from day 1 till week 24 or 48
- from time signed and dated ICF until follow-up visit 4 weeks after intake last medication

- 24 semanas después de la última dosis del fármaco del estudio previsto
- 4 semanas del fármaco en estudio
- 12 semanas del fármaco en estudio
- 4 semanas y 12 semanas del fármaco en estudio
- Final real del fármaco del estudio (semana 24, la semana 48 o la interrupción temprana)
- Finalización prevista del fármaco del estudio (semana 24 o 48 semanas)
- El período de seguimiento después de anteriores niveles indetectables de ARN del VHC en el final real de los fármacos del estudio (semana 24 o 48 o la interrupción temprana)
- Desde el día 1 hasta la semana 24 o 48
- desde el momento en que se ha firmado y fechado el consentimiento informado hasta la visita de seguimiento 4 semanas después de la útima toma de medicación.

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

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

Yes

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)

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.8.3

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

Australia

Brazil

France

Poland

Russian Federation

Spain

Sweden

United Kingdom

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

LSLV

Ultima visita del último 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:

146

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

F.4.2.2

In the whole clinical trial

150

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)

not different from normal treatment of the 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

2012-03-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-03-07

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

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