Clinical Trials Register

Summary
EudraCT Number:	2011-004483-30
Sponsor's Protocol Code Number:	GS-US-236-0115
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:	2012-03-02
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2011-004483-30

A.3

Full title of the trial

A Phase 3b Randomized, Open Label Study to Evaluate Switching from Regimens Consisting of a Ritonavir-boosted Protease Inhibitor (PI/r) plus Emtricitabine/Tenofovir Fixed-Dose Combination (FTC/TDF) to the Elvitegravir/Cobicistat/ Emtricitabine/Tenofovir Disoproxil Fumarate Single-Tablet Regimen (EVG/COBI/FTC/TDF) in Virologically Suppressed, HIV-1 Infected Patients.

Studio di fase 3, in aperto, randomizzato per valutare il passaggio da regimi costituiti da un inibitore della proteasi (PI/r) associato a una combinazione a dose fissa di emtricitabina/tenofovir (FTC/TDF) a un regime monocompressa di elvitegravir/cobicistat/emtricitabina/tenofovir disoproxil fumarato (EVG/COBI/FTC/TDF) in pazienti infetti da HIV-1 virologicamente soppressi.

A.3.1

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

This open label trial will recruit patients with HIV who are already receiving anti-HIV treatment which includes ritonavir and emtricitabine/tenofovir disoproxil fumurate (Truvada). Patients will remain on the same anti-HIV drugs as prior to the study (ritonavir and Truvada)or switch to receive an investigational single tablet regimen (EVG/COBI/FTC/TDF).

Studio in aperto in pazienti con HIV gia' in trattamento con ritonavir ed emitricitabina/tenofovir disoproxil fumarato (Truvada). I pazienti o continueranno la stessa terapia che seguivano prima dello studio (Ritonavir e Truvada) o passeranno al trattamento con farmaco sperimentale in una sola compressa, a base di elvitegravir/cobicitat/emtricitabina/tenofovir.

A.4.1

Sponsor's protocol code number

GS-US-236-0115

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	GILEAD SCIENCE INC.
B.1.3.4	Country	United States
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	Gilead Sciences 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	Gilead Sciences International Ltd
B.5.2	Functional name of contact point	Clinical Trials Mailbox
B.5.3	Address:
B.5.3.1	Street Address	Flowers Building, Granta Park
B.5.3.2	Town/ city	Great Abington, Cambridge
B.5.3.3	Post code	CB21 6GT
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	+44 01223 897 300
B.5.5	Fax number	+44 01223 897 284
B.5.6	E-mail	clinical.trials@gilead.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	EVG/COBI/FTC/TDF
D.3.2	Product code	NA
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	Elvitegravir
D.3.9.1	CAS number	697761-98-1
D.3.9.2	Current sponsor code	GS-9370
D.3.9.3	Other descriptive name	NA
D.3.9.4	EV Substance Code	NA
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	150
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Cobicistat
D.3.9.1	CAS number	1004316-88-4
D.3.9.2	Current sponsor code	GS-9350
D.3.9.3	Other descriptive name	NA
D.3.9.4	EV Substance Code	NA
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	150
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	EMTRICITABINE
D.3.9.1	CAS number	143491-57-0
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	NA
D.3.9.4	EV Substance Code	SUB01882MIG
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.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TENOFOVIR DISOPROXIL FUMARATE
D.3.9.1	CAS number	202138-50-9
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	NA
D.3.9.4	EV Substance Code	SUB12607MIG
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	300
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	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	TRUVADA*30CPR RIV 200MG/245MG
D.2.1.1.2	Name of the Marketing Authorisation holder	GILEAD SCIENCES Srl
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	EMTRICITABINE
D.3.9.1	CAS number	143491-57-0
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	NA
D.3.9.4	EV Substance Code	SUB01882MIG
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.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TENOFOVIR DISOPROXIL FUMARATE
D.3.9.1	CAS number	202138-50-9
D.3.9.4	EV Substance Code	SUB12607MIG
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	300
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.2.1.2	Country which granted the Marketing Authorisation	Italy
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
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	RITONAVIR
D.3.9.1	CAS number	155213-67-5
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	NA
D.3.9.4	EV Substance Code	SUB10342MIG
D.3.10	Strength
D.3.10.3	Concentration number	NA
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	Yes
D.3.11.13.1	Other medicinal product type	trattamento PI non definito nel protocollo

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

Human Immunodeficiency Virus (HIV-1) Infections

Infezione da virus dell'immunodeficienza umana (HIV-1)

E.1.1.1

Medical condition in easily understood language

HIV-1 infection

Infezione da HIV-1

E.1.1.2

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	PT
E.1.2	Classification code	10020161
E.1.2	Term	HIV infection
E.1.2	System Organ Class	10021881 - Infections and infestations

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	SOC
E.1.2	Classification code	10021881
E.1.2	Term	Infections and infestations
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 evaluate the non-inferiority of EVG/COBI/FTC/TDF relative to regimens consisting of a ritonavir-boosted protease inhibitor (PI/r) plus FTC/TDF in maintaining HIV-1 RNA < 50 copies/mL at Week 48 (Snapshot Analysis) in virologically suppressed, HIV-1 infected subjects.

Valutare la non inferiorità di EVG/COBI/FTC/TDF rispetto ai regimi costituiti da un inibitore della proteasi potenziato con ritonavir (PI/r) combinato con FTC/TDF nel mantenere livelli di HIV-1 RNA<50copie/ml alla Settimana 48 (analisi snapshot) nei soggetti infetti da HIV-1 virologicamente soppressi.

E.2.2

Secondary objectives of the trial

- To evaluate the change in CD4 cell count. - To evaluate the safety and tolerability of the regimens.

- Valutare le variazioni nella conta delle cellule CD4. - Valutare la sicurezza e la tollerabilità dei regimi.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Age ≥ 18 years. - Be on a stable antiretroviral regimen consisting of a ritonavir boosted PI plus FTC/TDF continuously for ≥ 6 consecutive months preceding the screening visit. - Documented undetectable plasma HIV-1 RNA levels (according to the local assay being used) for ≥ 6 months preceding the screening visit (measured at least twice). - Be on the first or second antiretroviral drug regimen; if on the second regimen, must not have had HIV-1 RNA above detectable levels (according to the local assay being used) at the time of change in antiretroviral drugs nor ever experienced two consecutive HIV-1 RNA above detectable levels(according to the local assay being used) after first achieving a confirmed HIV-1 RNA below detectable levels. - Documented historical genotype prior to starting initial antiretroviral therapy showing no known resistance to TDF or FTC, including, but not limited to the presence of reverse transcriptase resistance mutants K65R, M184V/I, or 3 or more thymidine analog-associated mutations (M41L, D67N, K70R, L210W, T215Y/F, K219Q/E/N/R). - No previous use of any approved or experimental integrase strand transfer inhibitor (INSTI) for any length of time. - HIV RNA < 50 copies/mL at the screening visit. - Estimated glomerular filtration rate ≥ 90 mL/min according to the Cockcroft-Gault formula at the screening visit.

-Età ≥ 18anni. - Assumere una terapia antiretrovirale stabile costituita da un PI potenziato con ritonavir in combinazione con FTC/TDF in modo continuativo da ≥ 6 mesi consecuitivi precedenti la visita di screening. -Livello plasmatico di HIV-1 RNA non rilevabile documentato (in base all'analisi locale utilizzata) per ≥ 6 mesi precedenti la visita di screening (valore misurato almeno due volte). -Primo o secondo regime con farmaco antiretrovirale; se si tratta del secondo regime, non devono avere presentato RNA di HIV-1 rilevabile (in accordo all'analisi locale effettuata) al momento del cambiamento di farmaco antiretrovirale né devono avere sperimentato due occorrenze consecutive di RNA di HIV rilevabile (in accordo all'analisi locale effettuata) dopo avere ottenuto un livello di RNA non rilevabile. -Genotipo storico documentato prima di inizare la prima terapia antiretrovirale che dimostri l'assenza di resistenza a TDF o FTC incluse, in modo non limitativo, le mutazioni di resistenza alla transcriptasi inversa K65R, M184V/I, o 3 o più mutazioni associate agli analoghi della timidina (M41L, D67N, K70R, L210W, T215Y/F, K219Q/E/N/R). - Non devono aver fatto alcun utlizzo in precedenza, per periodi di qualsiasi durata, di un inibitore dell'attività di strand transfer dell'integrasi (INSTI) approvato o sperimentale. - HIV RNA <50 copie/ml alla visita di screening. -Velocità di filtrazione glomerulare stimata (eGFR) ≥ 90ml/min con la formula di Cockcroft-Gault (C-G) alla visita di screening.

E.4

Principal exclusion criteria

- A new AIDS-defining condition diagnosed within the 30 days prior to screening (except CD4 cell count and/or percentage criteria). - Females who are breastfeeding. - Positive serum pregnancy test (female of childbearing potential). - Receiving drug treatment for Hepatitis C, or subjects who are anticipated to receive treatment for Hepatitis C during the course of the study. -Experiencing decompensated cirrhosis (e.g., ascites, encephalopathy, etc.). - Have an implanted defibrillator or pacemaker. - Current alcohol or substance abuse judged by the Investigator to potentially interfere with subject compliance. - A history of malignancy within the past 5 years (prior to screening) or ongoing malignancy other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma. Subjects with cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of Baseline and must not be anticipated to require systemic therapy during the study. - Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Baseline, except for intramuscular penicillin for the treatment of syphilis. - Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids during the study. - Subjects receiving ongoing therapy with any of the medications in the table listed in the Study Protocol, including drugs not to be used with EVG, COBI, FTC, TDF; or subjects with any known allergies to the excipients of EVG/COBI/FTC/TDF tablets, or Truvada tablets. - No anticipated need to initiate drugs during the study that are contraindicated. - Receiving other investigational drugs. - Participation in any other clinical trial without prior approval from the sponsor is prohibited while participating in this trial. - Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements.

- Nuova diagnosi di AIDS entro i 30 giorni prima dello screening (ad eccezione della conta delle cellule CD4 e/o criteri percentuali). - Donne durante l'allattamento. - Positività al test sierico di gravidanza (donne in età fertile). - Pazienti che assumono farmaci per il trattamento dell'epatite C, o che si prevede possano ricevere un trattamento per l'epatite C durante il corso dello studio. - Storia di cirrosi scompensata (ad esempio: ascite, encefalopatia, ecc.). - Soggetti cui è stato impiantato un defibrillatore o pacemaker. -Soggetti che fanno abuso di alcool o di sostanze che lo sperimentatore valuta come potenziali interferenti con l'aderenza al protocollo. -Storia di tumore maligno diagnosticato negli ultimi 5 anni (prima dello screening) o di neoplasie in corso diverse da sarcoma cutaneo di Kaposi (KS), carcinoma a cellule basali, o resecato, carcinoma squamoso cutaneo non invasivo. Soggetti con KS cutaneo sono elegibili, ma non devono aver ricevuto alcuna terapia sistemica per il KS 30 giorni prima del basale e non possono essere sottoposti a terapia sistemica durante lo studio. -Infezioni gravi, attive (diverse da HIV-1) che richiedono una terapia antibiotica parenterale o antifungina nei 30 giorni precedenti al basale, ad eccezione delle somministrazioni intramuscolari di penicillina per il trattamento della sifilide. -Soggetti che sono stati trattati con terapie immunosoppressive o agenti chemioterapici entro 3 mesi dallo screening dello studio o atti a ricevere questi farmaci o steroidi sistemici durante lo studio (ad es, corticosteroidi, immunoglobuline, e altre terapie a base di citochine). -Soggetti che sono in terapia con uno qualsiasi dei farmaci elencati nel protocollo alla sezione 4.3, inclusi i farmaci che non possono essere utilizzati con EVG, COBI, FTC, TDF, oppure soggetti con eventuali allergie note agli eccipienti delle compresse di EVG/COBI/FTC/TDF o compresse di Truvada. -Nessuna necessità prevista di assumere farmaci controindicati durante lo studio. -Soggetti in trattamento con altri farmaci sperimentali. -Partecipazione ad altre sperimentazioni cliniche senza l'approvazione preventiva da parte dello sponsor. -Altre condizioni cliniche o precedenti terapie che, a giudizio dello sperimentatore, rendono il soggetto inadatto allo studio o non in grado di rispettare la posologia.

E.5 End points

E.5.1

Primary end point(s)

The primary efficacy endpoint is the proportion of subjects who have HIV-1 RNA < 50 copies/mL as defined by the FDA snapshot analysis.

L'endpoint primario è valutare l'efficacia in termini di valori di HIV-1 RNA < 50 copie/ml definito dall'analisi istantanea della FDA.

E.5.1.1

Timepoint(s) of evaluation of this end point

48 weeks

48 settimane

E.5.2

Secondary end point(s)

1. The safety and tolerability of each treatment arm by assessing adverse events and clinical laboratory tests (haematology, chemistry and urinalysis). 2. The change from baseline in CD4 cell count in each treatment arm.

1. Valutare l'efficacia e la sicurezza di entrambi i bracci di trattamento, sulla base della valutazione degli eventi avversi e degli esami clinici di laboratorio (ematologia, chimica e urinanalisi). 2. Stabilire la variazione nella conta delle cellule CD4 al basale in ogni braccio di trattamento.

E.5.2.1

Timepoint(s) of evaluation of this end point

1. The safety and tolerability of each treatment arm over 48 weeks, namely at baseline, 4, 8, 12, 24, 36 and 48 weeks. 2. The change from baseline in CD4 cell count in each treatment arm at 48 weeks.

1. efficacia e sicurezza di entrambi i bracci di trattamento, al basale, a 4, 8, 12, 24, 36 e 48 settimane. 2. Variazione rispetto al basale della conta delle cellule CD4 in entrambi i bracci di trattamento alla settimana 48.

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

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)

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

Canada

Puerto Rico

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:

378

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

250

F.4.2.2

In the whole clinical trial

420

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)

After a patient has completed/terminated their study partecipation, long term care for the partecipant will remain the responsibility of their primary treating physician.

Dopo che i pazienti avranno completato/terminato la loro partecipazione allo studio, la terapia a lungo termine sarà sotto la responsabilità del loro medico curante.

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

2012-02-22

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-12-15

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2014-12-16

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials