Clinical Trials Register

Summary
EudraCT Number:	2011-004963-56
Sponsor's Protocol Code Number:	GS-US-236-0121
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

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2011-004963-56

A.3

Full title of the trial

A Phase 3b Randomized, Open Label Study to Evaluate Switching from Regimens Consisting of a Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) plus Emtricitabine (FTC) and Tenofovir DF (TDF) to the Eviltegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Single-Tablet Regimen (EVG/COBI/FTC/TDF) in Virologically Suppressed, HIV 1 Infected Patients.

Studio di fase 3b, randomizzato, in aperto per valutare il passaggio da regimi costituiti da un inibitore non-nucleosidico della transcriptasi inversa (NNRTI) piu' Emtricitabina (FTC) e Tenofovir DF (TDF) a un regime mono-compressa Elvitegravir/Cobicistat/Emtricitabina/Tenofovir Disoproxil Fumarato (EVG/COBI/FTC/TDF) in pazienti con infezione da HIV-1 virologicamente soppressi.

A.3.1

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

Open label trial in patients with HIV who are already receiving anti-HIV treatment which includes a Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) and emtricitabine/tenofovir disoproxil fumurate (Truvada). Patients will remain on the same anti-HIV drugs as prior to the study or switch to receive an investigational single tablet regimen (EVG/COBI/FTC/TDF) which contains to experimental drugs(EVG and COBI)

Studio clinico in aperto in pazienti con HIV gia' in trattamento antiretrovirale con inibitori della transcrittasi inversa non nucleosidici (NNRTI) ed emtricitabina/tenofovir disoproxil fumarato (Truvada). I pazienti rimarranno in trattamento con la stessa terapia precedente allo studio o passeranno all'assunzione di un regime di trattamento in un unica compressa(EVG/COBI/FTC/TDF) che contiene due medicinali sperimentali (EVG e COBI).

A.4.1

Sponsor's protocol code number

GS-US-236-0121

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	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	NA
D.3.2	Product code	EVG/COBI/FTC/TDF
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	Eviltegravir
D.3.9.1	CAS number	697761-98-1
D.3.9.2	Current sponsor code	GS-9137
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.3.9.4	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.3.9.4	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	NA
D.3.9.1	CAS number	NA
D.3.9.2	Current sponsor code	NNRTI
D.3.9.3	Other descriptive name	NA
D.3.9.4	EV Substance Code	NA
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	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

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 NNRTI plus FTC/TDF in mantaining HIV-1 RNA <50copies/ml at Week 48 (Snapshot Analysis) in virologically suppressed, HIV-1 infected subjects.

Valutare la non-inferiorità di EVG/COBI/FTC/TDF relativamente a regimi costituiti da un NNRTI più FTC/TDF per il mantenimento di HIV-1 RNA <50copie/ml alla Settimana 48 (analisi snapshot) in pazienti con infezione 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 eventuali variazioni della conta della cellule CD4. -Valutare la sicurezza e la tollerabilità dei regimi.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

-Be stable on the current formulation(s) of their first antiretroviral (ARV) regimen consisting of a NNRTI plus FTC/TDF for ≥ 6 consecutive months preceding the screening visit. This includes subjects that began their first regimen with individual drug components and subsequently simplified to include a fixed-dose combination formulation of the same drugs. Examples include NNRTI + FTC + TDF simplified to NNRTI + FTC/TDF or NNRTI + FTC/TDF simplified to NNRTI/FTC/TDF; -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) and never 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; -No previous use of any approved or experimental integrase strand transfer inhibitor (INSTI) for any length of time; -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); -HIV RNA <50 copies/ml at the screening visit; -Estimated glomerular filtration rate ≥ 90ml/min according to the Cockcroft-Gault at the screening visit.

-Stabilità dimostrata alla(e) formulazione(i) attuale(i) del primo regime antiretrovirale (ARV) costituito da un NNRTI più FTC/TDF da ≥6 mesi consecutivi precedenti alla visita di Screening. Questo comprende i soggetti che hanno iniziato il loro primo regime con singoli componenti del farmaco, successivamente semplificato con l’inclusione di una formulazione di combinazione a dose fissa degli stessi farmaci. Esempi comprendono NNRTI + FTC + TDF semplificato a NNRTI + FTC/TDF o NNRTI + FTC/TDF semplificato a NNRTI/FTC/TDF; -Livelli non rilevabili (soppressi) documentati di HIV-1 RNA nel plasma (in base ad analisi locale) per ≥6 mesi consecutivi prima della visita di Screening (misurati almeno due volte) senza mai rivelare per due volte consecutive un HIV-1 RNA al di sopra dei livelli rilevabili (in base ad analisi locale) dopo la prima conferma di HIV-1 RNA al di sotto dei livelli rilevabili; -Nessun uso precedente di un inibitore qualsiasi dell’integrasi dell’HIV (INSTI) approvato o sperimentale, per una qualsiasi durata di tempo; -Genotipo storico documentato prima di iniziare la terapia antiretrovirale che non mostri alcuna resistenza nota a TDF o FTC, compresa, a titolo meramente esemplificativo, la presenza di mutazioni della transcriptasi inversa K65R, M184V/I, o di 3 o più mutazioni associate ad analoghi della timidina (M41L, D67N, K70R, L210W, T215Y/F, K219Q/E/N/R); -HIV RNA < 50 copie/ml alla visita di Screening; -Velocità di filtrazione glomerulare stimata (eGFR) ≥90 ml/min calcolata in base alla 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.

-Nuova diagnosi di AIDS nei 30 giorni prima dell'ingresso in studio (ad eccezione della conta delle cellule CD4 o criteri percentuali); -Donne in allattamento; -Test sierologico positivo di gravidanza (donne potenzialmente fertili); -Pazienti in trattamento affetti da epatite C o soggetti che riceveranno un trattamento per l'epatite C; -Soggetti con cirrosi scompensata (es. ascite, encefalopatia); -Soggetti con impianto di pacemaker o defibrillatore; -Soggetti che fanno uso abituale di alcool o abuso di sostanze che a giudizio dello sperimentatore possano interferire con l'aderenza allo studio.

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 di efficacia primario è la percentuale di soggetti che raggiungono un HIV-1 RNA <50 copie/ml alla settimana 48 così come definito dall'analisi snapshot della FDA.

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 48

48 settimane

E.5.2

Secondary end point(s)

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

-Valutare la sicurezza e l'efficacia in entrambi i bracci di trattamento sulla base degli eventi avversi e degli esami clinici di laboratorio (ematologia, chimica ed urinanalisi). -Variazioni nella conta delle cellule CD4 dalla visita basale nei bracci di trattamento.

E.5.2.1

Timepoint(s) of evaluation of this end point

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

-La sicurezza e la tollerabilità di ogni braccio di trattamento saranno valutate al basale, alle settimana 4,8,12,24,36 e 48; -La variazione rispetto al basale delle cellule CD4 in ciascun braccio di trattamento sarà valutata 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

Australia

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

195

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

Dopo il termine della partecipazione allo studio, la terapia a lungo termine per i partecipanti sarà 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

2012-04-20

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-02-14

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2014-10-23

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