Clinical Trials Register

Summary
EudraCT Number:	2011-004885-14
Sponsor's Protocol Code Number:	AI452-017
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:	2012-08-29
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

2011-004885-14

A.3

Full title of the trial

A Phase 3, Randomized, Double-Blind, Controlled Study Evaluating the
Efficacy and Safety of Peginterferon Lambda-1a, with and without
Daclatasvir, Compared to Peginterferon Alfa-2a, Each in Combination with
Ribavirin, in the Treatment of Naìve Genotype 2 and 3 Chronic Hepatitis C
Subjects

Studio di fase III, Randomizzato, in doppio cieco, controllato di valutazione dell'efficacia e sicurezza di Peginterferone Lambda-1a, con e senza Daclatasvir, a confronto con Peginterferone alfa-2a ognuno in combinazione con Ribavirina, in soggetti affetti da Epatite-C Cronica Genotipo 2 e 3 naìve al trattamento.

A.3.1

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

Safety and Efficacy Study of Pegylated Interferon Lambda with and without
Daclatasvir, compared to Pegylated Interferon Alfa, plus Ribavirin in
Subjects with Hepatitis C Genotype 2 and 3

Studio sulla Sicurezza ed Efficacia di Interferone Lambda Peghilato, con e senza Daclatasvir, a confronto con Interferone Alfa Peghilato, piu' Ribavirina in soggetti con Epatite-C genotipo 2 e 3.

A.4.1

Sponsor's protocol code number

AI452-017

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	BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
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	Bristol-Myers Squibb International Corporation
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	Bristol-Myers Squibb International Corporation
B.5.2	Functional name of contact point	EU Study Start-Up Unit
B.5.3	Address:
B.5.3.1	Street Address	Parc de l'Alliance - Avenue de Finlande, 8
B.5.3.2	Town/ city	Braine-l'Alleud
B.5.3.3	Post code	1420
B.5.3.4	Country	Belgium
B.5.6	E-mail	clinical.trials@bms.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	Pegylated Interferon Lambda
D.3.2	Product code	BMS-914143 / PEG-rIL-29 / PEG IFN-λ1
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PEGINTERFERON LAMBDA-1a
D.3.9.1	CAS number	914617-98-4
D.3.9.2	Current sponsor code	BMS-914143 / PEG IFN-λ1
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	180
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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	Yes
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	HCV NS5A Replication Co-Factor Inhibitor
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	Comparator
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	Ribasphere
D.2.1.1.2	Name of the Marketing Authorisation holder	Three Rivers Pharmaceuticals, LLC
D.2.1.2	Country which granted the Marketing Authorisation	United States
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	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	RIBAVIRIN
D.3.9.1	CAS number	36791-04-5
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	Comparator
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	Pegasys
D.2.1.1.2	Name of the Marketing Authorisation holder	Roche Registration Limited
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.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PEGINTERFERON ALFA-2A
D.3.9.1	CAS number	198153-51-4
D.3.9.4	EV Substance Code	SUB16452MIG
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	360
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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	Yes
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use

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

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	15.0
E.1.2	Level	HLT
E.1.2	Classification code	10057212
E.1.2	Term	Hepatitis viral infections
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 is to evaluate, in treatment-naive subjects with
chronic HCV GT-2 or -3 infection:
• SVR12 following 24 weeks of treatment with Lambda/RBV and the
SVR12 following 24 weeks of treatment with alfa-2a/RBV
• SVR12 following 12 weeks of treatment with Lambda/RBV/DCV and
the SVR12 following 24 weeks of treatment with alfa-2a/RBV

L’obiettivo primario di questo studio è valutare nei soggetti naïve al trattamento affetti da epatite C cronica con genotipo 2 o 3:
• La SVR12 a seguito di 24 settimane di trattamento con Lambda/RBV e la SVR12 a seguito di 24 settimane di trattamento con alfa-2a/RBV
• La SVR12 a seguito di 12 settimane di trattamento con Lambda/RBV/DCV e la SVR12 a seguito di 24 settimane di trattamento con alfa-2a/RBV

E.2.2

Secondary objectives of the trial

• Evaluate the safety of 24 weeks of treatment with Lambda/RBV and 12
weeks of treatment with Lambda/RBV/DCV compared to 24 weeks of
treatment with alfa-2a/RBV in reducing treatment emergent cytopenic
abnormalities
• Evaluate the following on-treatment IFN-associated symptoms
following 24 weeks of treatment with Lambda/RBV and 12 weeks of
treatment with Lambda/RBV/DCV compared to 24 weeks of treatment
with alfa-2a/RBV:
− Flu-like symptoms
− Musculoskeletal symptoms
• Evaluate SVR24 by treatment group
• Evaluate, by treatment group, safety as measured by the frequency of
dose reductions, discontinuations due to adverse events (AEs), and
serious adverse events (SAEs)
• Evaluate SVR12, by treatment group, in subjects with GT-3 chronic
HCV infection
• Evaluate on-treatment IFN-associated constitutional symptoms

valutare:
•la risp virologica rapid (RVR) per gruppo di trattam
•la sicurezza di 24 sett di trattam con Lambda/RBV e 12 settimane di trattam con Lambda/RBV/DCV a confronto con 24 settimane di trattamento con alfa-2a/RBV nel ridurre le anomalie citopeniche causate dal trattamento
•i seguenti sintomi associati agli interferoni durante il trattam,dopo 24 settimane di trattamento con Lambda/RBV e 12 settimane di trattam con Lambda/RBV/DCV a confronto con 24 settimane di trattam con alfa-2a/RBV: sintomi simil-influenzali, sintomi muscoloscheletrici
•la SVR24 per gruppo di trattam
•la sicurezza, per gruppo di trattamento, misurata come la frequenza di riduzioni di dose, discontinuazioni dovute ad eventi avversi, ed eventi avversi seri (SAE)
•la SVR12 per gruppo di trattam, in sogg GT-3 con infezione cronica da HCV
•sintomi costituzionali durante il trattamento associati agli interfero

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Chronic hepatitis C, Genotype 2 or 3
• Naïve to prior anti-HCV therapy

•Epatite C Cronica, genotipo 2 o 3
•Naive a precedenti terapie anti-HCV

E.4

Principal exclusion criteria

• Infected with HCV other than Genotype 2 or 3
• Positive HBsAg, or HIV-1/HIV-2 antibody
• Evidence of liver disease other than HCV
• Active substance abuse
• Evidence of decompensated cirrhosis

•Infezione da HCV di genotipo diverso dal 2 o 3
•Positività per HbsAg, o anticorpi HIV-1/HIV-2
•Evidenza di malattia epatica diversa dall’HCV
•Uso attivo di sostanze da abuso
•Evidenza di cirrosi decompensata

E.5 End points

E.5.1

Primary end point(s)

The primary efficacy endpoint is the proportion of chronically infected
genotype 2 and 3 subjects who achieve SVR12.

L’endpoint primario di efficacia è la proporzione di soggetti con infezione cronica da HCV genotipo 2 e 3 che ottengono la SVR12

E.5.1.1

Timepoint(s) of evaluation of this end point

Post-treatment week 12

Settimana 12 post-trattamento

E.5.2

Secondary end point(s)

• Proportion of subjects with RVR
• Proportion of subjects with treatment emergent cytopenic
abnormalities
• Proportion of subjects with on-treatment interferon-associated flu-like
symptoms
• Proportion of subjects with on-treatment musculoskeletal symptoms
• Proportion of subjects with SVR24 by treatment group
• Proportion of subjects with on-treatment SAEs
• Proportion of subjects with dose reductions
• Proportion of subjects who discontinue due to AEs
• Proportion of subjects with SVR12 in subjects with GT-3 chronic HCV
infection
• Proportion of subjects with on-treatment constitutional symptoms

• Proporzione di soggetti con RVR
• Proporzione di soggetti con anomalie citopeniche dovute al trattamento
• Proporzione di soggetti con sindrome simil-influenzale associata all’interferone durante il trattamento
• Proporzione di soggetti con sintomi muscoloscheletrici durante il trattamento
• Proporzione di soggetti con SVR per gruppo di trattamento
• Proporzione di soggetti con SAE durante il trattamento
• Proporzione di soggetti con riduzioni di dose
• Proporzione di soggetti che discontinuano a causa di eventi avversi
• Proporzione di soggetti con SVR12 in soggetti con infezione cronica da HCV GT3
• Proporzione di soggetti con sintomi copstituzionali durante il trattamento

E.5.2.1

Timepoint(s) of evaluation of this end point

From Day 1 through 24 weeks post end treatment

Dal Giorno 1 fino a 24 settimane post-trattamento

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

Yes

E.6.11

Pharmacogenomic

Yes

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Outcomes Research Assessments, Resistance and Immunogenicity

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

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

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)

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

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

Argentina

Australia

Brazil

Canada

Chile

Hong Kong

India

Japan

Korea, Republic of

Mexico

New Zealand

Puerto Rico

Russian Federation

Singapore

Taiwan

United States

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

The end of the study is defined as LPLV. The last visit is defined as the
last post-treatment follow-up subject visit.
After the treatment and follow-up period, subjects treated with Lambda
may be asked to enroll in a separate follow-up observational study to
assess long-term virologic response and HCV-related complications.

Definita come LPLV. L’ultima visita è defcome l’ultima visita del FU post trattam. Successiv al periodo di trattam e di FU, i sogg tratt con Lambda potrebbero ess invitati a partecip in uno studio osservaz di FU separato

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

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:

1125

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

125

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

351

F.4.2.2

In the whole clinical trial

1250

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)

At the end of the study, BMS will not continue to supply study drug to
subjects/investigators unless BMS chooses to extend the study. The
investigator should ensure that the subject receives appropriate
standard of care to treat the condition under study.

Alla fine dello studio, BMS non continuerà a fornire farmaco in studio ai soggetti/sperimentatori, a meno che BMS decida di estendere lo studio. Lo sperimentatore dovrebbe assicurare che i soggetti ricevano l’appropriato standard of care per trattare la condizione in studio

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

2012-07-10

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-06-12

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2014-09-24

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Clinical trials