Clinical Trials Register

Summary
EudraCT Number:	2013-002726-23
Sponsor's Protocol Code Number:	TMC435HPC3016
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2013-10-24
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2013-002726-23

A.3

Full title of the trial

Phase 2, Open-Label Study to Investigate the Pharmacokinetics, Efficacy, Safety, and Tolerability of the Combination of Simeprevir (TMC435), Daclatasvir (BMS-790052) and Ribavirin (RBV) in Patients with Recurrent Chronic Hepatitis C Genotype 1b Infection after Orthotopic Liver Transplantation

Studio in aperto di fase 2 per studiare la farmacocinetica, l'efficacia, la sicurezza e la tollerabilità dell'associazione di simeprevir (TMC435), daclatasvir (BMS-790052) e ribavirina (RBV) in pazienti con infezione cronica ricorrente da epatite C di genotipo 1b dopo un trapianto di fegato ortotopico

A.3.1

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

A Study of Pharmacokinetics, Efficacy, Safety, Tolerability, of the Combination of Simeprevir (TMC435), Daclatasvir (BMS-790052), and Ribavirin (RBV) in Patients with Recurrent Chronic Hepatitis C Genotype 1b Infection after Orthotopic Liver Transplantation

Studio per studiare la farmacocinetica, l'efficacia, la sicurezza e la tollerabilità dell'associazione di simeprevir (TMC435), daclatasvir (BMS-790052) e ribavirina (RBV) in pazienti con infezione cronica ricorrente da epatite C di genotipo 1b dopo un trapianto di fegato ortotopico

A.4.1

Sponsor's protocol code number

TMC435HPC3016

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 R&D, Ireland
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 R&D, Ireland
B.4.2	Country	Ireland
B.4.1	Name of organisation providing support	JANSSEN CILAG SPA
B.4.2	Country	Italy
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	+31 715242166
B.5.5	Fax number	+31 715242110
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	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	JNJ-38733214-AAA - capsule, hard (G028) - 150mg
D.3.2	Product code	TMC435 (or R494617)
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	Simeprevir
D.3.9.2	Current sponsor code	TMC435
D.3.9.3	Other descriptive name	JNJ-38733214-AAA
D.3.9.4	EV Substance Code	SUB26723
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	150
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	Daclatasvir
D.3.2	Product code	BMS-790052 / DCV
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	DACLATASVIR
D.3.9.4	EV Substance Code	SUB34092
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: 3
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	Copegus 200 mg film-coated tablets
D.2.1.1.2	Name of the Marketing Authorisation holder	Roche Products Limited
D.2.1.2	Country which granted the Marketing Authorisation	Netherlands
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	Copegus 200 mg film-coated tablets
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	ribavirin
D.3.9.3	Other descriptive name	RIBAVIRIN
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.IMP: 4
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	JNJ-38733214-AAA - capsule, hard (G019) - 150mg
D.3.2	Product code	TMC435 (or R494617)
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	Simeprevir
D.3.9.2	Current sponsor code	TMC435
D.3.9.3	Other descriptive name	JNJ-38733214-AAA
D.3.9.4	EV Substance Code	SUB26723
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	150
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 (HCV) genotype-1b Infection

Infezione da epatite C di genotipo 1b

E.1.1.1

Medical condition in easily understood language

Hepatitis C Virus (HCV) genotype-1 Infection

Infezione da epatite C di genotipo 1b

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	PT
E.1.2	Classification code	10019744
E.1.2	Term	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

The primary objectives are:
- To evaluate the effect of steady-state simeprevir and daclatasvir on the steady-state pharmacokinetics of cyclosporine and tacrolimus when administered as a regimen containing simeprevir (150 mg qd), daclatasvir (60 mg qd) and RBV (1000 to 1200 mg per day) in post-OLT subjects with recurrent HCV genotype 1b infection
- To evaluate the efficacy of a 24-week treatment regimen containing simeprevir, daclatasvir, and RBV with respect to the proportion of HCV genotype 1b infected post-OLT subjects achieving sustained virologic response 12 weeks after EOT (SVR12)

Gli obiettivi primari sono i seguenti:
- Valutare l'effetto di simeprevir e daclatasvir allo steady-state sulla farmacocinetica allo steady-state di ciclosporina e tacrolimus quando si somministra un regime contenente simeprevir (150 mg una volta al giorno), daclatasvir (60 mg una volta al giorno) e RBV (1000-1200 mg al giorno) in soggetti che hanno subito un trapianto di fegato ortotopico con infezione ricorrente da HCV di genotipo 1b.
- Valutare l'efficacia di un regime di trattamento di 24 settimane contenente simeprevir, daclatasvir e RBV rispetto alla percentuale di soggetti con trapianto di fegato ortotopico e infezione da HCV di genotipo 1b che ottengono una risposta virologica duratura 12 settimane dopo la fine del trattamento (SVR12).

E.2.2

Secondary objectives of the trial

The secondary objectives are:
- To evaluate the pharmacokinetic profile of simeprevir and daclatasvir during a 24-week treatment regimen containing simeprevir, daclatasvir and RBV in post-OLT subjects with recurrent HCV genotype 1b infection
- To determine the need for dose adjustment of cyclosporine and tacrolimus during a 24-week treatment regimen containing simeprevir, daclatasvir and RBV in post-OLT subjects with recurrent HCV genotype 1b infection
- To evaluate the efficacy of a 24-week treatment regimen containing simeprevir, daclatasvir, and RBV with respect to the proportion of HCV genotype 1b infected post-OLT subjects achieving sustained virologic response 4 and 24 weeks after EOT (SVR4 and SVR24, respectively)
- To evaluate safety and tolerability of a 24-week treatment regimen containing simeprevir, daclatasvir and RBV in post-OLT subjects with recurrent HCV genotype 1b infection

Gli obiettivi secondari sono i seguenti:
Valutare il profilo farmacocinetico di simeprevir e daclatasvir durante un regime di trattamento di 24 settimane contenente simeprevir, daclatasvir e RBV in soggetti con trapianto di fegato ortotopico e infezione ricorrente da HCV di genotipo 1b.
Stabilire la necessità di un aggiustamento della dose di ciclosporina e tacrolimus durante un regime di trattamento di 24 settimane contenente simeprevir, daclatasvir e RBV in soggetti con trapianto di fegato ortotopico e infezione ricorrente da HCV di genotipo 1b.
Valutare l'efficacia di un regime di trattamento di 24 settimane contenente simeprevir, daclatasvir e RBV rispetto alla percentuale di soggetti con trapianto di fegato ortotopico e infezione da HCV di genotipo 1b che ottengono una risposta virologica duratura 4 e 24 settimane dopo la fine del trattamento (rispettivamente SVR4 e SVR24).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Liver transplant between 6 months and 10 years prior to the screening visit
-Hepatitis C virus (HCV) genotype 1 subtype b infection
- Screening HCV ribose nucleic acid level greater than 10,000 IU per milliliter
- HCV treatment-naïve participants must not have received post-OLT treatment with any approved or investigational drug for the treatment of HCV
- Receiving stable immunosuppressant therapy (ie, no change in dose in the last month) with cyclosporine or tacrolimus for more than 3 months prior to the screening visit

- Trapianto di fegato avvenuto tra 6 mesi e 10 anni prima della visita di screening
- Infezione da virus dell’epatite C (HCV) di genotipo 1 sottotipo b
- Concentrazione di acido ribonucleico dell’HCV maggiore di 10.000 IU per millilitro allo screening
- Partecipanti naive al trattamento per l’HCV che non siano stati trattati dopo il trapianto di fegato ortotopico con qualsiasi farmaco approvato o sperimentale per l’HCV
- Assunzione di una terapia immunosoppressiva stabile (ossia senza variazioni della dose nell'ultimo mese) con ciclosporina o tacrolimus da oltre 3 mesi prima della visita di screening

E.4

Principal exclusion criteria

- Evidence of acute or chronic hepatic decompensation after the liver transplantation (including ascites, bleeding varices or hepatic encephalopathy)
- Any liver disease of non-HCV etiology, including current evidence of graft rejection except the presence of liver steatosis
- Any other clinically significant disease that in the opinion of the investigator would be exacerbated by the known effects of ribavarin
- Coinfection with HCV of another genotype than genotype 1b, HIV type 1 or 2 (positive HIV-1 or HIV-2 antibodies test at screening), and hepatitis B virus (hepatitis B surface antigen positive)
- Multi-organ transplant that included heart, lung, pancreas, or kidney

- Evidenza di scompenso epatico acuto o cronico dopo il trapianto di fegato (compresi ascite, sanguinamento di varici o encefalopatia epatica)
- Qualsiasi epatopatia di eziologia diversa dall’HCV, inclusa attuale evidenza di rigetto dell’organo trapiantato, ad eccezione della presenza di steatosi epatica
- Qualsiasi altra malattia clinicamente significativa che, secondo lo sperimentatore, verrebbe esacerbata dagli effetti noti della ribavirina
- Coinfezione da HCV di un genotipo diverso dal genotipo 1b, da virus dell’HIV di tipo 1 o 2 (test degli anticorpi HIV-1 o HIV-2 positivo allo screening) o da virus dell’epatite B (antigene di superficie dell’epatite B positivo)
- Trapianto multiorgano comprendente cuore, polmone, pancreas o rene

E.5 End points

E.5.1

Primary end point(s)

1 - Number of participants with a sustained virologic response (SVR)12 Weeks after the end of treatment
2 - Maximum Observed Plasma Concentration (Cmax) of cyclosporine and tacrolimus
3 - Area Under the Plasma Concentration-Time Curve From Time Zero to Time at Last Observed Quantifiable Concentration (AUC[last]) of cyclosporine and tacrolimus

1 - Numero di partecipanti con risposta virologica duratura (SVR) 12 settimane dopo la fine del trattamento
2- Massima concentrazione plasmatica osservata (Cmax) di ciclosporina e tacrolimus
3- Area sotto la curva concentrazione plasmatica-tempo dal tempo zero al tempo all’ultima concentrazione quantificabile osservata (AUC[last]) di ciclosporina e tacrolimus

E.5.1.1

Timepoint(s) of evaluation of this end point

1 - Week 36
2 - Baseline, Week 2, 4, 8, 12
3 - Baseline, Week 2, 4, 8, 12

1- Settimana 36
2- Basale, Settimana 2, 4, 8, 12
3- Basale, Settimana 2, 4, 8, 12

E.5.2

Secondary end point(s)

1 - Maximum Observed Plasma Concentration (Cmax) of simprenavir and daclatasvir
2 - Time to Reach Maximum Observed Plasma Concentration (Tmax) of simprenavir and daclatasvir
3 - Predose (trough) concentration (C0h) of simprenavir and daclatasvir
4 - Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of simprenavir and daclatasvir
5 - Number of participants with dose adjustment of cyclosporine and tacrolimus during treament with
regimen simeprevir, daclatasvir and RBV
6 - Number of patients with a sustained virological response SVR4 after the end of treatment
7 - Number of participants with a sustained virologic response SVR24 after the end of treatment
8 - Number of participants with adverse events
9 - Number of participants with Undetectable HCV RNA (less than 25 IU/milliliter undetectable) and HCV RNA less than 25 IU/milliliter detectable
10 - Number of participants with HCV RNA level less than 100 IU/milliliter
11 - Number of participants with ontreatment failure after treatment with regimen simeprevir, daclatasvir and
RBV
12 - Number of participants with viral relapse after treatment with regimen simeprevir, daclatasvir and RBV
13 - Number of participants with HCV NS3/4A and NS5A sequences

1 - Massima concentrazione plasmatica osservata (Cmax) di simprenavir e daclatasvir
2- Tempo al raggiungimento della massima concentrazione plasmatica osservata (Tmax) di simprenavir e daclatasvir
3- Concentrazione pre-dose (valle) (C0h) di simprenavir e daclatasvir
4- Area sotto la curva dal tempo zero alla fine dell’intervallo di somministrazione (AUCtau) di simprenavir e daclatasvir
5- Numero di partecipanti con aggiustamento della dose di ciclosporina e tacrolimus durante il trattamento con il regime simeprevir, daclatasvir e RBV
6- Numero di pazienti con risposta virologica duratura SVR4 dopo la fine del trattamento
7- Numero di partecipanti con risposta virologica duratura SVR24 dopo la fine del trattamento
8- Numero di partecipanti con eventi avversi
9- Numero di partecipanti con RNA HCV non rilevabile (meno di 25 IU/millilitro non rilevabili) e RNA HCV inferiore a 25 IU/millilitro non rilevabili
10- Numero di partecipanti con concentrazione di RNA HCV inferiore a 100 IU/millilitro
11- Numero di partecipanti con fallimento durante il trattamento dopo il trattamento con il regime simeprevir, daclatasvir e RBV
12- Numero di partecipanti con recidiva virale dopo il trattamento con il regime simeprevir, daclatasvir e RBV
13- Numero di partecipanti con sequenze dell’HCV NS3/4A e NS5A

E.5.2.1

Timepoint(s) of evaluation of this end point

1 - Baseline, Week 2, 4, 8, 12
2 - Baseline, Week 2, 4, 8, 12
3 - Baseline, Week 2, 4, 8, 12
4 - Baseline, Week 2, 4, 8, 12
5 - Part 1: Days 10 to 14
6 - Week 28
7 - Week 48
8 - Up to Week 48
9 - Weeks 2, 4, 12 and 24
10 - Week 4
11 - Screening, baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24
12 - Screening, baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24
13 - Screening, baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24

1 - Basale, Settimana 2, 4, 8, 12
2- Basale, Settimana 2, 4, 8, 12
3- Basale, Settimana 2, 4, 8, 12
4- Basale, Settimana 2, 4, 8, 12
5- Parte 1: Giorni da 10 a 14
6- Settimana 28
7- Settimana 48
8- Fino alla Settimana 48
9- Settimane 2, 4, 12 e 24
10- Settimana 4
11- Screening, basale, Settimane 1, 2, 4, 8, 12, 16, 20, 24
12- Screening, basale, Settimane 1, 2, 4, 8, 12, 16, 20, 24
13- Screening, basale, Settimane 1, 2, 4, 8, 12, 16, 20, 24

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

Yes

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

- tolerability
- HCV NS3/4A and NS5A sequences determination

-tollerabilità
-determinazione sequenza HCV NS3/4A e NS5A

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

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)

Information not present in EudraCT

E.8.2.2

Placebo

Information not present in EudraCT

E.8.2.3

Other

Information not present in EudraCT

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

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

Last visit of the last subject

Ultima visita ultimo soggetto

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:

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

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)

expected normal treatment of that condition

normale trattamento per la patologia

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

2014-02-03

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-11-20

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

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IMP with orphan designation in the indication
Orphan Designation Number:
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