Clinical Trials Register

Summary
EudraCT Number:	2012-002515-25
Sponsor's Protocol Code Number:	LLC-TEL-2012-1
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2012-06-22
Trial 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

2012-002515-25

A.3

Full title of the trial

Pharmacokinetic interactions between Telaprevir and not powered Atazanavir with ritonavir in co-infected patients with HIV and HCV genotype 1 in treatment for chronic liver disease by HCV

Interacciones farmacocinéticas entre Telaprevir y Atazanavir no potenciado con ritonavir en pacientes coinfectados por el VIH y el VHC genotipo 1 en tratamiento para la hepatopatía crónica por el VHC.

A.3.1

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

Study about pharmacokinetic interactions between Telaprevir and Atazanavir in co-infected patients with HIV and hepatitis C wiht chronic liver disease due to hepatitis C.

Estudio farmacocinético de la interacción entre Telaprevir y Atazanavir en pacientes co-infectados por VIH y hepatitis C con enfermedad hepatica crónica por hepatitis C

A.4.1

Sponsor's protocol code number

LLC-TEL-2012-1

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	Luis López Cortes - FISEVI
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	Luis López Cortés - FISEVI
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	Unidad de Investigación Clínica y Ensayos Clínicos. Hospital Universitario Virgen del Rocío
B.5.2	Functional name of contact point	Clara M. Rosso Fernández
B.5.3	Address:
B.5.3.1	Street Address	Avda. Manuel Siurot S/N
B.5.3.2	Town/ city	Sevilla
B.5.3.3	Post code	41013
B.5.3.4	Country	Spain
B.5.4	Telephone number	0034955013414
B.5.5	Fax number	0034954232992
B.5.6	E-mail	claram.rosso.sspa@juntadeandalucia.es

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
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	Incivo
D.3.2	Product code	Telaprevir
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	It is a NS3-4A protease inhibitor reduces the amount of hepatitis C virus
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	2250
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	Yes
D.2.1.1.1	Trade name	Reyataz
D.2.1.1.2	Name of the Marketing Authorisation holder	Bristol-Myers Squibb
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	Reyataz
D.3.4	Pharmaceutical form	Capsule, hard
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	ATAZANAVIR
D.3.9.1	CAS number	229975-97-7
D.3.9.3	Other descriptive name	ATAZANAVIR
D.3.9.4	EV Substance Code	SUB20595
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	200 to 300
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

HIV–HCV co-infected patients

Pacientes coinfectados por VIH y VHC genotipo 1

E.1.1.1

Medical condition in easily understood language

HIV and hepatitis C con-infection

Pacientes infectados con VIH y hepatitis C

E.1.1.2

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	PT
E.1.2	Classification code	10020161
E.1.2	Term	HIV infection
E.1.2	System Organ Class	10021881 - Infections and infestations

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	10065949
E.1.2	Term	HCV coinfection
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 changes in plasma pharmacokinetic parameters (Cmax, Cmin, AUC0-8, t 12, and Cl) of Telaprevir 750 mg/8h administered with Atazanavir 200 mg/8h not powered, taking as reference the observed pharmacokinetic parameters when given with Atazanavir/ritonavir 300/ 100 mg per day or Raltegravir.

Evaluar los cambios en los parámetros farmacocinéticos plasmáticos (Cmax, Cmin, AUC0-8, t 1/2, y Cl) de Telaprevir 750 mg/8h administrado junto con Atazanavir 200 mg/12 h no potenciado, tomando como referencia los parámetros farmacocinéticos observados cuando se administra con Atazanavir/ritonavir 300 /100 mg día o Raltegravir.

E.2.2

Secondary objectives of the trial

To assess changes in plasma pharmacokinetic parameters of Atazanavir 200mg/12h with regard to his administration as 300/100 mg per day and if the concentrations achieved with this dose are suitable when administered together with Telaprevir 750 mg/8h

Evaluar los cambios en los parámetros farmacocinéticos plasmáticos de Atazanavir 200 mg/12h respecto a su administración como 300/100 mg día y si las concentraciones alcanzadas con esta pauta son adecuadas cuando se administra junto con Telaprevir 750 mg/8h.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. HIV–HCV co-infected patients over 18 years old under treatment with Pegylated Interferon, Ribavirine and Telaprevir according to the advices of Agencia Española del Medicamento y Productos Sanitarios.

2. Signed informed consent.

1. Pacientes mayores de 18 años coinfectados por VIH y VHC genotipo 1 en tratamiento con Interferón-α pegilado, Ribavirina y Telaprevir según las recomendaciones de la Agencia Española del Medicamento y Productos Sanitarios.

2. Consentimiento informado del paciente

E.4

Principal exclusion criteria

1. The usual exclusion criteria in clinical practice to start treatment with these drugs (Pegylated interferon, Ribavirine, Telaprevir and Atazanavir) according to national and international recommendations.

2. Concomitant medication or medicinal products that can interfere the pharmacokinetics of Telaprevir or Atazanavir.

3. Medical history of bad absorption or diarrhea (>3 stools) that could alter the absorption of these drugs.

1. Los criterios de exclusión habituales en la práctica clínica para iniciar tratamiento con estos fármacos (Interferón-α pegilado, Ribavirina, Telaprevir y Atazanavir) según las recomendaciones nacionales e internacionales.

2. Uso concomitante de fármacos o productos medicinales que pudieran alteran la farmacocinética de Telaprevir o Atazanavir.

3. Historia clínica que sugiera malabsorción o presencia de diarrea (>3 deposiciones/día) que pudiera interferir con la absorción de los fármacos en estudio.

E.5 End points

E.5.1

Primary end point(s)

To assess changes pharmacokinetic parameters (Cmax, Cmin, AUC0-8, t 12, and Cl) of Telaprevir 750 mg/8h administered with Atazanavir 200 mg/8h not powered.

Evaluar parámetros farmacocinéticos plasmáticos (Cmax, Cmin, AUC0-8, t1/2, y Cl) de Telaprevir administrado como 750 mg/8h administrado junto con Atazanavir no potenciado (200 mg/12 h).

E.5.1.1

Timepoint(s) of evaluation of this end point

Blood samples will be taken before Telaprevir and antiretroviral therapy and 1,2,3,4,6,7,8,10 and 12 hours after the dose of Telaprevir and antiretroviral therapy.

Se obtendrán muestras de sangre inmediatamente antes y tras 1, 2, 3, 4, 6, 7, 8, 10 y 12 horas tras la toma de Telaprevir y terapia antirretroviral.

E.5.2

Secondary end point(s)

To assess pharmacokinetic parameters of Atazanavir 200mg/12h with regard to his administration as 300/100 mg per day.

Evaluar los parámetros farmacocinéticos de Atazanavir administrado como 200 mg/12h respecto a su administración como 300/100 mg/día.

E.5.2.1

Timepoint(s) of evaluation of this end point

Between 7-10 days after the change of treatment, blood samples will be taken before and after 1, 2, 3, 5, 6, 7, 8, 10, 12 hours after the dose of Telaprevir and Atazanavir.

Entre 7 y 10 días después del cambio de tratamiento, se tomarán muestras de sangre inmediatamente antes y tras 1, 2, 3, 5, 6, 7, 8, 10, 12 horas tras la toma observada de Telaprevir y de Atazanavir.

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

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

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

Yes

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

Yes

E.7.1.3.1

Other trial type description

pharmacokinetic

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

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

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

Yes

E.8.4

The trial involves multiple sites in the 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

LVLS

UVUP (ultima visita, último paciente incluido)

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

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)

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.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

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)

It is no different from normal treatment of this condition

No difiere de los cuidados habituales para esta patología

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

2012-09-10

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-06-27

P. End of Trial
P.	End of Trial Status	Ongoing

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