Clinical Trials Register

Summary
EudraCT Number:	2015-003370-33
Sponsor's Protocol Code Number:	M15-684
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:	2018-02-21
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

2015-003370-33

A.3

Full title of the trial

An Open-Label, Single Arm Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Treatment-Naïve Adults With Genotype 1b Hepatitis C Virus (HCV) Without Cirrhosis (GARNET).

Sperimentazione in aperto,a braccio singolo per valutare la sicurezza ed l’efficacia di Ombitasvir/Paritaprevir/Ritonavir e Dasabuvir in soggetti adulti con infezione da virus dell’Epatite C (HCV) di Genotipo 1b, non cirrotici e naïve rispetto al trattamento (GARNET).

A.3.1

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

A Study to Evaluate Ombitasvir/ Paritaprevir / Ritonavir and Dasabuvir in Treatment-Naïve Hepatitis C Virus Genotype 1b-Infected Adults.

Sperimentazione per valutare Ombitasvir/ Paritaprevir/Ritonavir e Dasabuvir in soggetti adulti con infezione da virus dell’Epatite C (HCV) di Genotipo 1b naïve rispetto al trattamento.

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

M15-684

A.5.4

Other Identifiers

Name:

N.A.

Number:

N.A.

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	ABBVIE DEUTSCHLAND GMBH & CO. KG
B.1.3.4	Country	Germany
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	AbbVie Inc.
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	AbbVie Ltd.
B.5.2	Functional name of contact point	EU Clinical Trials Helpdesk
B.5.3	Address:
B.5.3.1	Street Address	AbbVie House, Vanwall Business Park, Vanwall Road
B.5.3.2	Town/ city	Maidenhead, Berkshire
B.5.3.3	Post code	SL64UB
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	0044 1628 561090
B.5.5	Fax number	0044 1628 461153
B.5.6	E-mail	eu-clinical-trials@abbvie.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	Ombitasvir Paritaprevir Ritonavir
D.2.1.1.2	Name of the Marketing Authorisation holder	AbbVie Ltd.
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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	Ombitasvir Paritaprevir Ritonavir
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	Ombitasvir
D.3.9.1	CAS number	1456607-70-7
D.3.9.2	Current sponsor code	ABT-267
D.3.9.3	Other descriptive name	Ombitasvir
D.3.9.4	EV Substance Code	SUB131058
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	12.5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	RITONAVIR
D.3.9.1	CAS number	155213-67-5
D.3.9.2	Current sponsor code	Ritonavir
D.3.9.3	Other descriptive name	RITONAVIR
D.3.9.4	EV Substance Code	SUB10342MIG
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	50
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Paritaprevir
D.3.9.1	CAS number	1456607-71-8
D.3.9.2	Current sponsor code	ABT-450
D.3.9.3	Other descriptive name	Paritaprevir
D.3.9.4	EV Substance Code	SUB166312
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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	Dasabuvir
D.2.1.1.2	Name of the Marketing Authorisation holder	AbbVie Ltd
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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	abt-333 dasabuvir
D.3.2	Product code	abt-333 dasabuvir
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	Dasabuvir
D.3.9.1	CAS number	1456607-55-8
D.3.9.2	Current sponsor code	ABT-333; Dasabuvir
D.3.9.3	Other descriptive name	ABT-333; Dasabuvir
D.3.9.4	EV Substance Code	SUB131059
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	250
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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 Infection

Infezione da virus dell’Epatite C

E.1.1.1

Medical condition in easily understood language

Hepatitis C Infection

Infezione da virus dell’Epatite 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	20.1
E.1.2	Level	PT
E.1.2	Classification code	10008912
E.1.2	Term	Chronic 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 objective of this study is to assess the efficacy (the percentage of subjects achieving a 12-week sustained virologic response, SVR12 [HCV ribonucleic acid {RNA} < lower limit of quantification {LLOQ} 12 weeks following treatment]) of coformulated ombitasvir/paritaprevir/ritonavir and dasabuvir for 8 weeks in treatment-naïve adults with HCV genotype 1b infection without cirrhosis.

L’obiettivo primario di questa sperimentazione è quello di valutare l’efficacia (percentuale di soggetti che raggiunge una risposta virologica sostenuta dopo 12 settimane, SVR12 [acido ribonucleico {RNA} dell’HCV < limite inferiore di quantificazione {LLOQ} 12 settimane dopo il trattamento]) della co-formulazione ombitasvir/paritaprevir/ritonavir e dasabuvir somministrati per 8 settimane in soggetti adulti affetti da infezione da HCV di genotipo 1b , non cirrotici e naïve rispetto al trattamento.

E.2.2

Secondary objectives of the trial

Secondary objectives are to assess the percentage of subjects with virologic failure during treatment, the percentage of subjects with virologic relapse post-treatment, and the percentage of female subjects
with SVR12 and the percentage of subjects with low baseline viral load (HCV RNA < 6,000,000 IU/mL) with SVR12 in previously untreated adults with genotype 1b HCV infection.

Gli obiettivi secondari sono la valutazione della percentuale di soggetti con fallimento durante il trattamento, la percentuale di soggetti con recidiva virologica post-trattamento e la percentuale di soggetti di sesso femminile che ottengono SVR12 e la percentuale di soggetti con una bassa carica virale al baseline (HCV RNA < 6.000.000 UI/mL) che ottengono SVR12 , in una popolazione di soggetti adulti con infezione da HCV di genotipo 1b che non abbiano mai ricevuto in precedenza trattamento anti-HCV.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male or female at least 18 years of age at time of Screening.
2. HCV infection at Screening defined as: Positive for anti-HCV antibody (Ab) at Screening and HCV RNA > 1,000 IU/mL at Screening.
3. Screening laboratory result indicating HCV genotype 1b infection only.
4. Subject has never received commercial or investigational anti-HCV agents for hepatitis C infection (treatment-naïve subject).
5. Absence of cirrhosis, as documented by meeting one of the following criteria (per local standard practice):
• A liver biopsy within 12 months prior to or during screening demonstrating the absence of cirrhosis, e.g., a METAVIR Score of 3 or less, Ishak score of 4 or less;
• A FibroScan performed within 3 months prior to or during screening with a score of < 12.5 kPa; or
• A screening FibroTest score of ≤ 0.72 and Aspartate Aminotransferase to Platelet Ratio Index (APRI) ≤ 2 (Subjects with a screening FibroTest
result that is ≤ 0.72 and an APRI > 2, or a FibroTest result that is > 0.72 and an APRI ≤ 2 must have a FibroScan or liver biopsy performed during screening to document absence of cirrhosis. These subjects will be allowed to enroll only with approval of the AbbVie Scientific Director).
If more than one method is used to determine the presence or absence of cirrhosis, the results of a liver biopsy will take precedence over FibroScan and FibroTest and the results of FibroScan will take
precedence over FibroTest.

1. Soggetti di ambo i sessi e di età pari o superiore a 18 anni al momento dello Screening.
2.Infezione da HCV allo Screening definito in base a: Positività aglianticorpi (Ab) anti-HCV allo Screening e livelli di HCV RNA > 1.000 UI/mL allo Screening.
3.HCV esclusivamente di genotipo 1b confermato da analisi di laboratorio allo screening.
4.Soggetti che non abbiano mai ricevuto alcun agente anti-HCV, commercializzato o sperimentale, per l’infezione da epatite C (soggetti naïve al trattamento).
5.Assenza di cirrosi, documentata da uno dei seguenti criteri (secondo pratica standard locale):
•Biopsia epatica nei 12 mesi precedenti lo screening o durante lo screening che dimostra l’assenza di cirrosi, ad esempio punteggio METAVIR pari o inferiore a 3, punteggio Ishak pari o inferiore a 4;
•Esame FibroScan eseguito nei 3 mesi precedenti lo screening o durante lo screening, con punteggio < 12,5 kPa; oppure
•Punteggio FibroTest allo screening ≤ 0,72 e indice di rapporto tra aspartato aminotransferasi e piastrine (APRI) ≤ 2 (Nel caso di soggetti che allo screening abbiano un risultato FibroTest ≤ 0,72 e indice APRI > 2, oppure
risultato FibroTest > 0,72 e indice APRI ≤ 2 sarà necessario eseguire un esame FibroScan o una biopsia epatica durante lo screening al fine di documentare l’assenza di cirrosi. Tali soggetti potranno essere arruolati solo previa approvazione del Direttore Scientifico di AbbVie.
Qualora venga utilizzata più di una metodica per rilevare presenza o assenza di cirrosi, i risultati della biopsia epatica prevarranno sul risultato di FibroScan e FibroTest, ed il risultato del FibroScan prevarrà sul risultato del FibroTest.

E.4

Principal exclusion criteria

1. Evidence of HCV genotype or subtype other than GT1b during screening, including the presence of GT1b with another genotype or GT1
subtype.
2. Positive test result for Hepatitis B surface antigen (HbsAg) or confirmed positive anti-HIV antibody (HIV Ab) (test).
3. Any current or past clinical evidence of cirrhosis such as ascites or esophageal varices or prior biopsy showing cirrhosis.
4. Screening laboratory analyses showing any of the following abnormal laboratory results:
• Calculated creatinine clearance (using Cockcroft-Gault method) < 30 mL/min
• Albumin < 3.5 g/dL
• Hemoglobin < 10 g/dL
• Platelets < 120,000 cells per mm3
• Total bilirubin ≥ 3.0 mg/dL
• International normalized ratio (INR) > 1.5. Subjects with a known
inherited blood disorder and INR > 1.5 may be enrolled with permission
of the AbbVie Scientific Director.
5. Clinically significant abnormalities or co-morbidities, other than HCV infection that make the subject an unsuitable candidate for this study or to receive ombitasvir/paritaprevir/ritonavir or dasabuvir in the opinion of the investigator.

1.Evidenza durante lo screening di genotipo o sottogenotipo HCV diverso dal genotipo 1b, compresa la presenza concomitante di genotipo 1b e di un altro genotipo o di un altro sottotipo del genotipo 1.
2.Positività all’antigene di superficie per l’Epatite B (HbsAg) o agli anticorpi per il virus dell’immunodeficienza umana(test HIV ab).
3.Qualsiasi evidenza clinica in atto o pregressa di cirrosi, come ascite, varici esofagee, oppure riscontro di cirrosi a una pregressa biopsia.
4.Analisi di laboratorio allo screening che dimostrino una qualsiasi delle seguenti alterazioni dei parametri di laboratorio:
•Clearance della creatinina (calcolata mediante metodo Cockcroft-Gault) < 30 mL/min
•Albumina < 3,5 g/dL
•Emoglobina < 10 g/dL
•Piastrine < 120.000 cellule per mm3
•Bilirubina totale ≥ 3.0 mg/dL
•INR (International normalized ratio) > 1,5. I soggetti con nota patologia ematica ereditaria e con valori INR > 1,5 potranno essere arruolati previa autorizzazione del Direttore Scientifico di AbbVie.
5.Anomalie clinicamente significative o comorbidità, diverse dall’infezione da HCV, che a giudizio dello sperimentatore rendono il soggetto non idoneo a partecipare a questa sperimentazione o a ricevere il trattamento con ombitasvir/paritaprevir/ritonavir o dasabuvir.

E.5 End points

E.5.1

Primary end point(s)

The primary efficacy endpoint is number and percentage of ITT subjects with SVR12 (HCV RNA < LLOQ 12 weeks after the last dose of study drugs).

L’endpoint primario di efficacia è rappresentato dal numero e dalla percentuale di soggetti della popolazione ITT che abbiano ottenuto SVR12 (HCV RNA < LLOQ 12 settimane dopo l’ultima dose dei medicinali sperimentali).

E.5.1.1

Timepoint(s) of evaluation of this end point

12 weeks after the last subject last dose.

12 settimane dopo l’ultima dose dei medicinali sperimentali dell’ultimo soggetto.

E.5.2

Secondary end point(s)

1. The percentage of subjects with on-treatment virologic failure, defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase of at least 1 log10 IU/mL from nadir during treatment, failure to suppress during treatment (all on-treatment values of HCV RNA ≥ LLOQ) among subjects with at least 6 weeks (active study drug duration ≥ 36 days) of treatment;
2. The percentage of subjects with post-treatment relapse, defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last dose of study drug (up to and including the SVR12 assessment time point) among subjects completing treatment and with HCV RNA < LLOQ at the end of treatment.
3. The percentage of female subjects with SVR12.
4. The percentage of subjects with baseline HCV RNA < 6,000,000 IU/mL with SVR12.

1. La percentuale di soggetti con fallimento virologico in corso di trattamento, definito come conferma di livelli di HCV RNA ≥ LLOQ successivamente a riscontri di HCV RNA < LLOQ in corso di trattamento, oppure aumento confermato di almeno 1 log10 UI/mL rispetto al nadir durante il trattamento, mancata soppressione in corso di trattamento (tutti i valori di HCV RNA ≥ LLOQ durante il trattamento) nei soggetti che abbiano ricevuto il trattamento per almeno 6 settimane (durata del trattamento attivo con il medicinale sperimentale ≥ 36 giorni);
2. La percentuale di soggetti con recidiva post-trattamento, definita come livelli confermati di HCV RNA ≥ LLOQ nell’intervallo compreso fra la conclusione del trattamento e 12 settimane dopo l’ultima dose del medicinale sperimentale (fino alla valutazione di SVR12, compresa) nei soggetti che hanno portato a termine il trattamento e che presentano livelli di HCV RNA < LLOQ alla fine del trattamento.
3.La percentuale di soggetti di sesso femminile che ottengono SVR12.
4.La percentuale di soggetti con livelli basali di HCV RNA < 6.000.000 UI/mL che ottengono SVR12.

E.5.2.1

Timepoint(s) of evaluation of this end point

12 settimane dopo l’ultima dose dei medicinali sperimentali dell’ultimo soggetto.

12 weeks after the last subject last dose.

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

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)

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

Information not present in EudraCT

E.8.1.4

Double blind

Information not present in EudraCT

E.8.1.5

Parallel group

Information not present in EudraCT

E.8.1.6

Cross over

Information not present in EudraCT

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.8.2.4

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

Australia

Canada

France

Germany

Israel

Italy

Spain

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

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:

120

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

F.4.2.2

In the whole clinical trial

160

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)

No treatment planned for subjects that complete the 24 Week post treatment period.

Nessun programma di trattamento è previsto per i soggetti che completano il periodo di 24 settimane dopo il trattamento.

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

2015-12-02

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-11-20

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2016-12-01

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