Clinical Trials Register

Summary
EudraCT Number:	2015-004200-38
Sponsor's Protocol Code Number:	64294178HPC2001
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:	2018-02-23
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2015-004200-38

A.3

Full title of the trial

A Phase 2b, Multicenter, Randomized, Open-label Study to Investigate the Efficacy, Safety and Pharmacokinetics of Different Treatment Regimens of AL-335, Odalasvir, and Simeprevir in Treatment-naïve and Treatment-experienced Subjects With Chronic Hepatitis C Virus Genotype 1, 2, 4, 5 and 6 Infection Without Cirrhosis.

Studio di fase 2b, multicentrico, randomizzato, in aperto, volto a valutare l’efficacia, la sicurezza e la farmacocinetica di diversi regimi di trattamento con AL-335, odalasvir e simeprevir in soggetti naive al trattamento e precedentemente sottoposti a trattamento, con infezione da virus dell’epatite C cronica, genotipo 1, 2, 4, 5 e 6, senza cirrosi

A.3.1

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

A Phase 2 study of Different Treatment Combinations of AL-335, odalasvir and simeprevir in subjects with chronic hepatitis C virus infection

Studio di fase 2 di diverse combinazioni di trattamento di AL-335, odalasvir e simeprevir in soggetti con infezione da virus dell’epatite C cronica.

A.3.2

Name or abbreviated title of the trial where available

A Phase 2 study of Different Treatment Combinations of AL-335, odalasvir and simeprevir in subjects

Studio di fase 2 di diverse combinazioni di trattamento di AL-335, odalasvir e simeprevir in soggett

A.4.1

Sponsor's protocol code number

64294178HPC2001

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 R&D LLC
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Janssen-Cilag International NV (Janssen Biologics)
B.5.2	Functional name of contact point	Clinical Registry Group
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	2333 CM
B.5.3.4	Country	Netherlands
B.5.4	Telephone number	0031715242166
B.5.5	Fax number	0031715242110
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 (G034)
D.3.2	Product code	SMV
D.3.4	Pharmaceutical form	Capsule, hard
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	simeprevir
D.3.9.1	CAS number	923604-59-5
D.3.9.2	Current sponsor code	SMV
D.3.9.3	Other descriptive name	JNJ-38733214-AAA (G034)
D.3.9.4	EV Substance Code	SUB64783
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	75
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.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ODALASVIR DIHYDRATE
D.3.9.2	Current sponsor code	ND
D.3.9.3	Other descriptive name	JNJ-64289901-ZAT
D.3.9.4	EV Substance Code	SUB181206
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	25
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	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.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	JNJ-64146212-AAA
D.3.9.3	Other descriptive name	AL-335
D.3.9.4	EV Substance Code	SUB181205
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	400
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 virus infection.

Infezione da virus dell' Epatite C Cronica

E.1.1.1

Medical condition in easily understood language

Chronic Hepatitis C

Epatite C Cronica

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	20.0
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

• evaluate efficacy, ie, sustained virologic response 12 weeks after the end of treatment (SVR12), of a combination treatment with AL-335, ODV, and SMV for 6 and 8 weeks in chronic HCV genotype 1, 2, 4, 5 o 6 infected subjects without cirrhosis,

•Valutare l’efficacia, ovvero una risposta virologica sostenuta dopo 12 settimane dalla fine del trattamento (SVR12), di un trattamento combinato con AL-335, ODV e SMV per 6 e 8 settimane in soggetti affetti da HCV cronica di genotipo 1, 2, 4, 5 o 6 senza cirrosi.

E.2.2

Secondary objectives of the trial

• evaluate safety and tolerability, SVR4 and SVR24, on-treatment viral kinetics, of a 6- and 8-week treatment regimen containing AL-335, ODV, and SMV in subjects without cirrhosis
• evaluate incidence of on treatment failure during treatment
• evaluate incidence of viral relapse after treatment
• assess changes from baseline in HCV NS3/4A, NS5A, and NS5B sequence in subjects not achieving SVR,
• evaluate effect of presence or absence of baseline HCV NS3/4A polymorphisms (including Q80K), NS5A polymorphisms and/or NS5B polymorphisms on treatment outcome
• evaluate concordance between SVR4, SVR12, and SVR24,
• evaluate PK of AL-335, ODV, SMV and their metabolites in plasma,
• evaluate relationship between population-derived exposure parameters of AL-335, ODV, and SMV with SVR12 and safety.
• explore impact of HCV and its treatment with AL-335+ODV+SMV and AL-335+ODV on the Fatigue Severity Scale total score and 5-level EuroQol 5-Dimension Visual Analog Scale score.

• valutare sicurezza e tollerabilità, SVR4 e SVR24, su cinetiche di trattamento virale, di regime di trattamento di 6 e 8 settimane contenente AL-335, ODV, e SMV in soggetti senza cirrosi • valutare l'incidenza di fallimento del trattamento in corso di trattamento • valutare l'incidenza di recidiva virale dopo il trattamento • valutare i cambiamenti rispetto al basale nella sequenza NS3 / 4A,'NS5A, e NS5B dell’HCV in soggetti che non raggiungono SVR, •Valutare gli effetti della presenza o assenza di polimorfismi di NS3/4A (incluso Q80K), polimorfismi NS5A e/o polimorfismi NS5B dell’HCV al basale sull’esito del trattamento • valutare concordanza tra SVR4, SVR12, e SVR24, • valutare la PK di AL-335, ODV, e SMV e loro metaboliti nel plasma. • Valutare la relazione tra i parametri di esposizione derivati dalla popolazione di AL-335 (e relativi metaboliti), ODV e SMV con la SVR12 e la sicurezza.
• esplorare l'impatto di HCV e il suo trattamento con AL-335 + ODV + SMV mediante punteggi

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

nd-Fri Mar 18 00:00:00 CET 2016-nd-nd
• exploratory host DNA research related to SMV, ODV, AL-335 (and metabolites), or HCV infection.
• rich serial PK substudy, performed at selected study sites, rich serial PK blood sampling for the measurement of plasma concentrations of AL-
335 (and its metabolites ALS-022227 and ALS-022399), SMV, and ODV will be performed in 20 subjects.
• sparse PK substudy, performed at selected sites, sparse PK sampling for AL-335 (and metabolites), SMV, and ODV will be performed for a subset of approximately 20 subjects who are not participating in the rich serial PK substudy.

nd-Fri Mar 18 00:00:00 CET 2016-nd-la ricerca esplorativa di DNA ospite relativa al SMV, ODV, AL-335 (e metaboliti), o infezione da HCV
• la ricerca esplorativa di DNA ospite relativa al SMV, ODV, AL-335 (e metaboliti), o infezione da HCV
• nel sottostudio PK seriale completa, eseguito nei siti di studio selezionati, il prelievo di sangue PK seriale completa per la misura delle concentrazioni plasmatiche di AL-335 (e dei suoi metaboliti ALS-022227 e ALS-022399), SMV, e ODV sarà eseguito in 20 soggetti.
• nel sottostudio di PK sparsa, eseguito nei siti selezionati, la raccolta campioni PK sparsa per AL-335 (e metaboliti), SMV, e ODV verrà eseguita per un sottoinsieme di circa 20 soggetti che non partecipano al sottostudio PK seriale completa

E.3

Principal inclusion criteria

• Documented chronic HCV infection: diagnosis of HCV infection >6 months before the first screening assessment, either by detectable HCV RNA, an HCV positive antibody test or presence of histological changes consistent with chronic hepatitis in a liver biopsy
• All subjects must have HCV genotype 1, 2, 4, 5 or 6 infection, determined at screening
• HCV RNA plasma levels >10,000 IU/mL
• HCV treatment-naïve

• Documentata infezione cronica da HCV: diagnosi di infezione da HCV > 6 mesi prima della prima valutazione di screening, sia di HCV rilevabile RNA, test degli anticorpi positivo HCV o la presenza di alterazioni istologiche coerente con epatite cronica in una biopsia epatica
• Tutti i soggetti devono essere affetti da HCV di genotipo 1, 2, 4, 5 o 6 determinata al momento dello screening
• livelli di HCV RNA nel plasma > 10.000 UI / mL
• HCV naive al trattamento

E.4

Principal exclusion criteria

• Co-infection with multiple HCV genotypes
• Co-infection with HIV
• Presence of cirrhosis
• Prior exposure to an HCV DAA, either in combination with PegIFN or IFN-free
• Any evidence of liver disease of non-HCV etiology
• Evidence of hepatic decompensation (history or current clinical evidence of ascites, bleeding varices or hepatic encephalopathy)
• Subjects with HCV genotype 3 infection.

• Coinfezione da HCV con genotipi multipli
• Coinfezione da virus dell’immunodeficienza umana (HIV)
• Presenza di cirrosi
• Precedente esposizione a un DAA per l’HCV, sia in combinazione con PegIFN sia senza IFN
• Qualsiasi evidenza di malattia epatica di eziologia non-HCV
• Evidenza di scompenso epatico (anamnesi o corrente evidenza clinica di ascite, varici sanguinanti o encefalopatia epatica).
• Infezione da HCV di genotipo 3

E.5 End points

E.5.1

Primary end point(s)

Percentage of Chronic HCV Infected Subjects who Achieve Sustained Virologic Response 12 weeks After the end of Treatment (EOT) (SVR12)

Percentuale di soggetti con infezione cronica da HCV che raggiungono Risposta virologica sostenuta dopo 12 settimane dalla fine del trattamento (EOT) (SVR12)

E.5.1.1

Timepoint(s) of evaluation of this end point

12 weeks after the EOT (Week 6 or 8)

12 settimane dopo la fine del trattamento EOT (settimana 6 o 8)

E.5.2

Secondary end point(s)

• Percentage of Subjects with Sustained Virologic Response at 4 (SVR4) and 24 (SVR24) Weeks After EOT • Percentage of Subjects With Viral Relapse During Follow-up up to 24 Weeks After EOT • Percentage of Subjects With On-treatment Failure • Percentage of Subjects With on-treatment Virologic Response • Time to Achieve Undetectable HCV RNA <LLOQ HCV RNA • Effect of Presence or Absence of Baseline NS5A, NS5B or NS3/4A Genes Polymorphisms on Treatment Outcome • Changes from Baseline in Amino Acid Sequence in the HCV NS3/4A, NS5A and NS5B Genes in Subjects, who did not Achieve SVR • Change from Baseline Over Time in 5-level EuroQol 5 Dimension (EQ5D5L) Visual Analog Scale (VAS) Score • Change from Baseline Over Time in Fatigue Severity Scale (FSS) Total Score • Percentage of Subjects with Clinically Significant Positive or Negative Change from Baseline in FSS Total and EQ5D5L VAS at Week 4, EOT (Week 6 or 8), Follow up Week 4, 12 and 24 • Duration of Clinically Significant Positive or Negative Response from Baseline in FSS Total and EQ5D5L VAS at Week 4, EOT (Week 6 or 8), Follow up Week 4, 12 and 24 • Predose (trough) Plasma Concentration (C0h) • Area Under the Curve From Time Zero to 24 Hours Postdose (AUC 24) • Number of Subjects with Adverse Events (AEs)

•La percentuale di soggetti con SVR4 e SVR24. •La percentuale di soggetti con recidiva virale durante il follow-up fino a 24 settimane dopo EOT •La percentuale di soggetti con fallimento al trattamento. •La percentuale di soggetti con risposta virologica al trattamento: •Tempo per raggiungere HCV RNA <LLOQ HCV RNA non rilevabili. •Effetto della presenza o assenza al basale dei polimorfismi NS3/4A, NS5A o NS5B sull’esito del trattamento. •Cambiamenti dal basale nella sequenza aminoacidica delle regioni NS3/4A, NS5A e NS5B dell’HCV nei soggetti che non raggiungono la SVR. •Variazione dal basale nel corso tempo del punteggio della scala visiva analogica (VAS) del questionario sulla qualità della vita EuroQol a 5 livelli e 5 dimensioni (EQ5D5L) •Variazione dal basale nel corso tempo del punteggio totale della scala di gravità della fatica (FSS) •percentuale di soggetti con variazione clinicamente significativa Positiva o negativa rispetto al basale nel punteggio totale della FSS e EQ5D5L VAS alla settimana 4, EOT (Settimana 6 o 8), Follow-up Settimana 4, 12 e 24 •Durata della risposta clinicamente significativa positiva o negativa rispetto al basale della FSS totale e EQ5D5L VAS alla settimana 4, EOT (Settimana 6 o 8), follow-up Settimana 4, 12 e 24 •predose (minimo) della concentrazione plasmatica (C0h) •Area sotto la curva dal tempo zero a 24 ore dopo la dose (AUC 24) •Numero di soggetti con eventi avversi (EA)

E.5.2.1

Timepoint(s) of evaluation of this end point

Each secondary end point respectively: • 4 and 24 weeks after EOT • Up to Week 24 of follow-up • Up to 6 or 8 weeks depending upon the Treatment received • Up to 6 or 8 weeks • Up to 24 weeks of follow-up • Baseline • Baseline up to 24 weeks of follow-up • Baseline up to 24 weeks of follow-up • Baseline up to 24 weeks of follow-up • Week 4, EOT, follow up Week 4, 12 and 24 • Week 4, EOT, follow up Week 4, 12 and 24 • Baseline (Day 1) up to EOT • Baseline (Day 1) up to EOT • Screening (Day 1) up to Week 38 (= Week 24 of Follow-up)

Ogni endpoint secondario, rispettivamente: • 4 e 24 settimane dopo EOT • fino alla settimana 24 di follow-up • Fino a 6 o 8 settimane a seconda del trattamento ricevuto • Fino a 6 o 8 settimane • Fino a 24 settimane di follow-up • Baseline • Baseline fino a 24 settimane di follow-up • Baseline fino a 24 settimane di follow-up • Baseline fino a 24 settimane di follow-up • Settimana 4, EOT, follow-up Settimana 4, 12 e 24 • Settimana 4, EOT, follow-up Settimana 4, 12 e 24 • Baseline (1 ° giorno) fino a EOT • Baseline (1 ° giorno) fino a EOT • Screening (1 ° giorno) fino alla settimana 38 (= settimana 24 di follow-up

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

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

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)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

dati storici

historical data

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

Information not present in EudraCT

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

Belgium

Canada

France

Germany

Italy

Poland

Singapore

Spain

Sweden

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

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

Number of subjects for this age range:

F.1.1.1

In Utero

Information not present in EudraCT

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

Information not present in EudraCT

F.1.1.3

Newborns (0-27 days)

Information not present in EudraCT

F.1.1.4

Infants and toddlers (28 days-23 months)

Information not present in EudraCT

F.1.1.5

Children (2-11years)

Information not present in EudraCT

F.1.1.6

Adolescents (12-17 years)

Information not present in EudraCT

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

285

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

Yes

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

201

F.4.2.2

In the whole clinical trial

300

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)

For subjects who do not achieve (SVR), sponsor will provide investigator with available sequencing data at baseline and at time of failure. Where possible, subjects may be allowed to enroll in a subsequent study (re-treatment with the selected dosing regimen) if subject meets relevant entry criteria. If not possible, sponsor will reimburse treatment with standard of care in respective country.

Per i soggetti che non raggiungono (SVR), lo sponsor fornirà all’investigator i dati di sequenziamento disponibili al basale e al momento del fallimento. Ove possibile, i soggetti potranno essere autorizzati a partecipare ad un successivo studio (ri-trattamento con il regime di dosaggio selezionato) qualora il soggetto rientra nei criteri di inclusione rilevanti. Se non è possibile, lo sponsor rimborserà il trattamento con terapia standard del rispettivo paese.

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

2016-10-18

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-06-28

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

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IMP with orphan designation in the indication
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