Clinical Trials Register

Summary
EudraCT Number:	2011-003067-30
Sponsor's Protocol Code Number:	AI444-043
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:	2011-12-16
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

2011-003067-30

A.3

Full title of the trial

A Phase 3, Open Label Study of Safety and Efficacy with BMS-790052 plus Peg-Interferon Alfa 2a and Ribavirin in Previously Untreated HCV Patients Coinfected with Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV).

Studio in aperto di fase 3, per valutare la sicurezza e l'efficacia del farmaco BMS-790052 in combinazione con Peginterferone Alfa-2a e Ribavirina in soggetti affetti da epatite C (HCV) naive al trattamento coinfettati con il virus dell'immunodeficienza umana (HIV) e il virus dell'epatite C.

A.3.1

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

Safety and Efficacy study of BMS-790052 plus Peg-Interferon Alfa 2a and Ribavirin in untreated Hepatitis C Patients Coinfected with HIV Virus

Studio di sicurezza ed efficacia del farmaco BMS-790052 in combinazione con Peginterferone Alfa-2a e Ribavirina in soggetti affetti da epatite C (HCV) mai trattati precedentemente coinfettati con il virus dell'immunodeficienza umana (HIV)

A.4.1

Sponsor's protocol code number

AI444-043

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	Italy
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	HCV NS5A Replication Co-Factor
D.3.2	Product code	BMS-790052
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.3.9.2	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	30
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	HCV NS5A Replication Co-Factor
D.3.2	Product code	BMS-790052
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.3.9.2	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	Copegus
D.2.1.1.2	Name of the Marketing Authorisation holder	Roches Laboratories Inc
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.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 / HIV-1 co-infection

Soggetti affetti da epatite C (HCV) naive al trattamento coinfettati con il virus dell'immunodeficienza umana (HIV) e il virus dell’epatite C

E.1.1.1

Medical condition in easily understood language

Chronic Hepatitis C / HIV-1 co-infection

Soggetti affetti da epatite C (HCV) naive al trattamento coinfettati con il virus dell'immunodeficienza umana (HIV) e il 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	14.1
E.1.2	Level	LLT
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

To assess efficacy, as determined by the proportion of subjects with SVR12, defined as HCV RNA < Limit of quantification (LOQ) detectable or undetectable, at post-treatment Week 12.

Valutare l’efficacia, determinata dalla proporzione dei soggetti con una risposta virologica sostenuta a 12 settimane (SVR12), definita come HCV RNA < LOQ (determinabile o non determinabile) al follow-up della settimana 12.

E.2.2

Secondary objectives of the trial

• To assess the proportion of subjects with genotype 1 infection who achieve : -HCV RNA < LOQ (detectable or undetectable) -HCV RNA undetectable at weeks: 1, 2, 4, 6, 8, and 12; both Weeks 4 and 12; EOT, posttreatment Week 24 (SVR24); and post-treatment Week 48 (SVR48) for subjects who achieve VR (4&12) • To assess safety, as measured by the frequency of SAEs and discontinuations due to AEs • To assess the proportion of subjects who are receiving HAART and who maintain their HIV RNA < 40 copies/mL and the proportion of subjects who experience confirmed HIV RNA ≥ 400 copies/mL at end of treatment for subjects who are receiving HAART • To assess the relationship between efficacy and the rs12979860 single nucleotide polymorphisms (SNP) in the IL28B gene

Proporz di sogg HCV genotipo 1 che otterranno:
1.valore HCV RNA<LOQ(determ. o non determ.)
2.valore di HCV RNA non determ. alle settim: 1,2,4,6,8 e 12; ad entrambe le settim 4 e 12; EOT, settim 24 post-trattamento (SVR24); settim 48 post-trattamento (SVR48) per i soggetti che otterranno la risposta virologica alle settimane di trattamento 4 e 12 [VR (4&12)].
-Sicurezza, misurata dalla frequenza degli EA seri e le discontinuaz dal trattamento dovute ad EA.
-Efficacia, determinata dalla proporz dei soggetti che stanno ricevendo terapia HAART e che mantengono il valore di HIV RNA<40 copie/mL e l’efficacia, determinata dalla proporz dei soggetti che stanno ricevendo terapia HAART per i quali sia confermato il valore di HIV RNA magg o uguale a 400 copie/mL alla fine del trattam
-Relazione tra l’efficacia e il polimorfismo a singolo nucleotide (SNP) del rs12979860 nel gene IL28B.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

•Males and females, 18 to 70 years of age; •HCV Genotype 1a or 1b; •HCV-Treatment naive; •HCV RNA > 10,000 IU/mL at screening; •HIV-1 infection;(approximately 250 subjects receiving HAART, up to 50 subjects not receiving HAART); •For subjects receiving HAART, HIV RNA must be below < 40 copies/mL at screening and must be < 400 copies/ml for at least 6 months prior to screening.

• Maschi e femmine con un’età compresa tra 18 e 70 anni;
• Soggetti affetti da HCV cronico di genotipo 1a o 1b;
• Soggetti naive al trattamento anti-HCV;
• Soggetti con un HCV RNA > 10.000 IU/mL alla visita di screening;
• Soggetti affetti da virus HIV-1 (circa 250 soggetti riceventi HAART e circa 50 non riceventi HAART;
• Per i soggetti riceventi HAART, l’HIV RNA deve essere < 40 copie/mL alla visita di screening e < 400 copie/mL per almeno 6 mesi prima della visita di screening.

E.4

Principal exclusion criteria

•Subjects (receiving HAART) who had first initiated anti-retroviral therapy within the last 6 months of Day 1; •Subjects (receiving HAART) who have changed their anti-retroviral regimen within the last 3 months prior to Day 1 (other than prohibited HAART regimens (see section 3.4.1), which may be substituted at least one month prior to Day 1); •Use of prohibited HAART;regimens (see section 3.4.1) within one month of Day 1 and throughout the treatment period of the trial; •Laboratory values: neutrophil count < 1500 cells/μL (<1200 cells/ μL for blacks), platelet count < 90,000 cells/μL, hemoglobin < 11 g/dL for females, hemoglobin < 12 g/dL for males; •Total bilirubin ≥ 34 μmol/L (or ≥ 2 mg/dL) unless subject has a documented history of Gilbert's disease or antiretroviral regimen contains atazanavir.

• Soggetti riceventi HAART che hanno iniziato la prima terapia antivirale entro 6 mesi precedenti il Giorno 1;
• Soggetti riceventi HAART che hanno sostituito la loro terapia antivirale entro 3 mesi precedenti il Giorno 1 (tranne la sostituzione con le terapie diverse da i regimi HAART proibiti, per cui si chiede di fare riferimento alla sezione 3.4.1 del protocollo, che possono essere sostituite almeno un mese prima dal Giorno 1);
• L’uso di regimi HAART proibiti (fare riferimento alla sezione 3.4.1 del protocollo) entro un mese dal Giorno 1 e durante il periodo di trattamento dello studio;
• Valori di laboratorio: conta dei neutrofili < 1500 cells/microL (< 1200 cells/microL per soggetti di colore), conta piastrinica < 90.000 cells/microL, emoglobina < 11 g/dL per soggetti donne, emoglobina < 12 g/dL per soggetti uomini;
• Bilirubina totale ≥ 34 micromol/mL (o ≥ 2 mg/dL) a meno che sia documentato che il soggetto abbia una storia di malattia di Gilbert o che assuma atazanavir come terapia antiretrovirale.

E.5 End points

E.5.1

Primary end point(s)

Proportion of subjects with SVR12, defined as HCV RNA < LOQ (detectable or undetectable) at post-treatment Week 12

La proporzione dei soggetti con una risposta virologica sostenuta a 12 settimane (SVR12), definita come HCV RNA < LOQ (determinabile o non determinabile) al follow-up della settimana 12

E.5.1.1

Timepoint(s) of evaluation of this end point

Follow-up Week 12

Follow-up alla settimana 12

E.5.2

Secondary end point(s)

1. To assess the proportion of subjects with Genotype 1 infection who achieve HCV RNA < LOQ (detectable or undetectable) at weeks: 1, 2, 4, 6, 8, and 12; both Weeks 4 and 12; EOT, post-treatment Week 24 (SVR24); and post-treatment Week 48 (SVR48) for subjects who achieve VR (4&12). 2. To assess the proportion of subjects with Genotype 1 infection who achieve HCV RNA undetectable at weeks: 1, 2, 4, 6, 8 and 12; both Weeks 4 and 12; EOT, post-treatment Week 12; post-treatment Week 24; and post-treatment Week 48 for subjects who achieve VR (4&12). 3. To assess safety, as measured by the frequency of SAEs and discontinuations due to AEs; 4. To assess the proportion of subjects who are receiving HAART and who maintain their HIV RNA < 40 copies/mL and the proportion of subjects who experience confirmed HIV RNA ≥ 400 copies/mL at end of treatment for subjects who are receiving HAART; 5. Proportion of subjects with SVR12 at post treatment Week 12 by the rs12979860 in the IL28B gene.

- Valutare la proporzione dei soggetti HCV di genotipo 1 che otterranno il valore di HCV RNA < LOQ (determinabile o non determinabile) alle settimane: 1, 2, 4, 6, 8 e 12; ad entrambe le settimane 4 e 12; EOT, settimana 24 post-trattamento (SVR24); settimana 48 post-trattamento (SVR48) per i soggetti che otterranno la risposta virologica alle settimane di trattamento 4 e 12 [VR (4&12)]; - Valutare la proporzione dei soggetti HCV di genotipo 1 che otterranno il valore di HCV RNA non determinabile alle settimane: 1, 2, 4, 6, 8 e 12; ad entrambe le settimane 4 e 12; EOT, settimana 12 post-trattamento; settimana 24 post-trattamento; settimana 48 post-trattamento (SVR48) per i soggetti che otterranno la risposta virologica alle settimane di trattamento 4 e 12 [VR (4&12)]; - La frequenza degli Eventi Avversi Seri e le discontinuazioni dal trattamento dovute ad Eventi Avversi fino alla fine del trattamento (per un massimo di 48 settimane) più 30 giorni; - La proporzione dei soggetti con un valore SVR12 alla settimana 12 post-trattamento con rs12979860 SNP nel gene IL28B; - La proporzione dei soggetti che stanno ricevendo terapia HAART e che mantengono il valore di HIV RNA < 40 copie/mL e la proporzione dei soggetti che stanno ricevendo terapia HAART per i quali sia confermato il valore di HIV RNA maggiore o uguale a 400 copie/mL alla fine del trattamento (per un massimo di 48 settimane).

E.5.2.1

Timepoint(s) of evaluation of this end point

1. On-treatment Weeks 1, 2, 4, 6, 8, 12, EOT, post-treatment Week 24 and post-treatment Week 48 for subjects who achieve VR (4 & 12). 2. On-treatment Weeks 1, 2, 4, 6, 8, 12, EOT, post-treatment Weeks 12, 24 and post-treatment Week 48 for subjects who achieve VR (4 &12). 3. Throughout treatment period 4. End of treatment 5. Post-treatment Week 12

1. Alle settimane di trattamento 1, 2, 4, 6, 8, 12, EOT, settimana 24 post-trattamento; settimana 48 post-trattamento per i soggetti che otterranno la risposta virologica alle settimane di trattamento 4 e 12 [VR (4&12)]
2. Alle settimane di trattamento 1, 2, 4, 6, 8, 12, EOT, settimana 12 post-trattamento; settimana 24 post-trattamento; settimana 48 post-trattamento per i soggetti che otterranno la risposta virologica alle settimane di trattamento 4 e 12 [VR (4&12)]
3. Durante il periodo di trattamento
4. Alla fine del trattamento
5. Alla settimana 12 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

Yes

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

HCV and HIV Resistance Testing; Exploratory Biomarker Assessments

Mutazioni di resistenza per HIV e HCV; Valutazioni di Biomarker esplorativo

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

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

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

Puerto Rico

Russian Federation

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

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

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:

475

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

158

F.4.2.2

In the whole clinical trial

500

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

Al termine dello studio, lo Sponsor non continuerà a fornire il farmaco in studio ai soggetti/investigatori a meno che lo Sponsor decida di estendere la sperimentazione. Lo sperimentatore dovrà assicurare che il soggetto riceva un adeguato trattamento per 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

2012-01-22

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-11-15

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2014-09-10

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