Clinical Trials Register

Summary
EudraCT Number:	2016-000435-41
Sponsor's Protocol Code Number:	GOIRC-01-2016
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:	2020-12-17
Trial 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

2016-000435-41

A.3

Full title of the trial

Phase II, Open Label, Randomized, Biomarker Study of Immune-mediated Mechanism of Action of Neoadjuvant Subcutaneous (SC) Trastuzumab in Patients with Operable or Locally Advanced/Inflammatory HER2-positive Breast Cancer (ImmunHER)

Studio randomizzato di fase 2 per la analisi dei meccanismi immunologici della chemioterapia neoadiuvante, contenente Trastuzumab in formulazione sottocutanea, in pazienti affette da carcinoma mammario HER2-positivo operabile o localmente avanzato. Protocollo ImmunHER.

A.3.1

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

”Studio randomizzato di fase 2 per la analisi dei meccanismi immunologici della chemioterapia neoadiuvante contenente Trastuzumab, in formulazione sottocutanea, in pazienti affetti da carcinoma mammario HER2-positivo operabile o localmente avanzato”

A.3.2

Name or abbreviated title of the trial where available

ImmunHER protocol

Protocollo ImmunHER

A.4.1

Sponsor's protocol code number

GOIRC-01-2016

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT03144947

A.5.4

Other Identifiers

Name:

ImmunHER

Number:

GOIRC-01-2016

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	GRUPPO ONCOLOGICO ITALIANO DI RICERCA CLINICA (GOIRC)
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Roche S.p.A.
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	GOIRC Gruppo Oncologico Italiano di Ricerca Clinica
B.5.2	Functional name of contact point	Medical Oncology Unit, University H
B.5.3	Address:
B.5.3.1	Street Address	via Gramsci 14
B.5.3.2	Town/ city	Parma
B.5.3.3	Post code	43126
B.5.3.4	Country	Italy
B.5.4	Telephone number	00390521702316
B.5.5	Fax number	00390521995448
B.5.6	E-mail	amusolino@ao.pr.it

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	HERCEPTIN - 150 MG POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE ENDOVENOSA 1 FLACONCINO USO ENDOVENOSO
D.2.1.1.2	Name of the Marketing Authorisation holder	ROCHE REGISTRATION LIMITED
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.3.1	Product name	Trastuzumab
D.3.2	Product code	[RO0452317]
D.3.4	Pharmaceutical form	Powder for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TRASTUZUMAB
D.3.9.1	CAS number	180288-69-1
D.3.9.2	Current sponsor code	RO0452317
D.3.9.3	Other descriptive name	Immunoglobulin G1, anti-(human p185neu receptor) (human-mouse monoclonal rhuMab HER2 gamma1-chain), disulfide with human-mouse monoclonal rhuMab HER2 light chain, dimer
D.3.9.4	EV Substance Code	PRD4134987
D.3.10	Strength
D.3.10.1	Concentration unit	mg/kg milligram(s)/kilogram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	8
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	Yes
D.3.11.13.1	Other medicinal product type	Anticorpo monoclonale umanizzato
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	HERCEPTIN - 600 MG/5 ML SOLUZIONE INIETTABILE - USO SOTTOCUTANEO - FLACONCINO (VETRO) DA 6 ML - 1 FLACONCINO
D.2.1.1.2	Name of the Marketing Authorisation holder	ROCHE REGISTRATION LIMITED
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.3.1	Product name	Trastuzumab
D.3.2	Product code	[RO0452317]
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	TRASTUZUMAB
D.3.9.1	CAS number	180288-69-1
D.3.9.2	Current sponsor code	RO0452317
D.3.9.3	Other descriptive name	mmunoglobulin G1, anti-(human p185neu receptor) (human-mouse monoclonal rhuMab HER2 gamma1-chain), disulfide with human-mouse monoclonal rhuMab HER2 light chain, dimer
D.3.9.4	EV Substance Code	PRD4135002
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	Yes
D.3.11.13.1	Other medicinal product type	anticorpo monoclonale IgG1 umanizzato
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	PERJETA - 420 MG - CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) - 30 MG/ML - 1 FLACONCINO
D.2.1.1.2	Name of the Marketing Authorisation holder	ROCHE REGISTRATION LIMITED
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.3.1	Product name	Pertuzumab
D.3.2	Product code	[RO04368451]
D.3.4	Pharmaceutical form	Concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PERTUZUMAB
D.3.9.1	CAS number	380610-27-5
D.3.9.2	Current sponsor code	RO04368451
D.3.9.3	Other descriptive name	pertuzumab
D.3.9.4	EV Substance Code	PRD4135006
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
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	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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	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	Yes
D.3.11.13.1	Other medicinal product type	Anticorpo monoclonale

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

HER2-positive Breast Cancer

carcinoma mammario HER2-positivo

E.1.1.1

Medical condition in easily understood language

Breast Cancer

carcinoma mammario

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10006187
E.1.2	Term	Breast cancer
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

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 variations of host immune response parameters to either SC or IV neoadjuvant trastuzumab formulations in primary HER2-positive breast cancer.

Valutare le variazioni dei parametri di risposta immunitaria a ciascuna delle formulazioni (SC o EV) di trastuzumab somministrato in fase neoadiuvante nel carcinoma mammario HER2-positivo.

E.2.2

Secondary objectives of the trial

To evaluate clinical efficacy, safety and tolerability of the combination regimens.

Valutare efficacia clinica, sicurezza e tollerabilità del regime di trattamento in studio.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Previously untreated, infiltrating primary breast cancer with locally advanced, inflammatory, or early stage tumor (either greater than 2 cm in diameter or node positive) with no evidence of metastatic disease.
• HER2 positivity (either immunohistochemistry 3+ or fluorescent in situ hybridization amplification).
• Age 18 or older.
• Eastern Cooperative Oncology Group performance status of 0 to 1.
• Availability of tumor tissue for biologic and molecular examination before starting primary treatment.
• Left ventricular ejection fraction within the institutional range of normal.
• Normal organ and marrow function.
• Adequate contraception methods for women of childbearing potential.
• Prior diagnosis of cancer is allowed as long as patient is free of disease and has been off treatment for the prior malignancy for a minimal interval of 3 years.
• Written informed consent.

• Pazienti affette da carcinoma mammario, non precedentemente trattato, localmente avanzato, infiammatorio o in fase precoce (superiore a 2 cm di diametro o con positività linfonodale) senza evidenza di malattia metastatica.
• Positività per HER2 (3+ con immunoistochimica o amplificazione genica con ibridazione fluorescente in situ).
• Età >= 18 anni.
• Performance status (Eastern Cooperative Oncology Group)< = 1.
• Disponibilità di tessuto tumorale bioptico prima dell’inizio del trattamento per esame biologico e molecolare.
• Frazione di eiezione ventricolare sinistra nella norma.
• Normale funzione di organo e midollare.
• Adeguato metodo contraccettivo per le donne in età fertile .
• Una precedente diagnosi di neoplasia è consentita a patto che la paziente sia libera da malattia e fuori trattamento per un intervallo minimo di 3 anni .
• Consenso informato scritto.

E.4

Principal exclusion criteria

• Either stage I or IV breast cancer.
• Prior trastuzumab or pertuzumab.
• Any prior chemotherapy.
• Treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to enrolment.
• Undergone major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic) <= 4 weeks prior to starting study drug or who have not recovered from side effects of such surgery.
• Breast radiotherapy prior to starting study.
• Known hypersensitivity to the investigational drugs or any of their excipients.
• Evidence of any disease, neurological or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, or puts the patient at high risk for treatment-related complications.
• Moderate/severe hepatic impairment (Child-Pugh B/C).
• Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Concurrent malignancy or malignancy within 3 years prior to study enrollment, with the exception of adequately treated basal cell carcinoma, squamous cell carcinoma or other non-melanomatous skin cancer, or in-situ carcinoma of the uterine cervix.
• Pregnancy or breastfeeding (breast feeding should be discontinued to be enrolled in the study).
• Women of childbearing potential that refusal to adopt adequate contraceptive measures.
• Unwilling or unable to comply with the protocol.

• Stadio di malattia I o IV.
• Precedente terapia con trastuzumab o pertuzumab.
• Precedente chemioterapia o radioterapia.
• Trattamento con qualsiasi altra terapia sperimentale, o partecipazione a un altro trial clinico nei 28 giorni prima della registrazione in studio.
• Intervento di chirurgia maggiore (intra-toracica, intra-addominale o intra-pelvica) <= 4 settimane prima di iniziare il trattamento in studio o non recupero dalle conseguenze post-operatorie di tale intervento chirurgico.
• Ipersensibilità nota ai farmaci in studio o a qualsiasi dei loro eccipienti.
• Evidenza di qualsiasi malattia, disfunzione neurologica o metabolica, o condizione clinica, che controindica l'uso dei farmaci in studio o mette la paziente ad alto rischio di complicanze correlate al trattamento.
• Compromissione epatica moderata/grave (Child-Pugh B/C).
• Condizioni cliniche in fase attiva o non controllate tra le quali, ad esempio, infezione in corso o attiva, insufficienza cardiaca congestizia sintomatica, angina pectoris instabile, aritmia cardiaca, o malattie psichiatriche/situazioni sociali che limiterebbero la conformità ai requisiti dello studio.
• Concomitante tumore maligno insorto entro tre anni prima dell'arruolamento nello studio, ad eccezione del carcinoma basocellulare, del carcinoma a cellule squamose o altro tumore cutaneo non-melanoma, o carcinoma in situ della cervice uterina adeguatamente trattati.
• Gravidanza o allattamento (l’allattamento deve essere interrotto per essere arruolati nello studio).
• Donne in età fertile che rifiutano di adottare adeguate misure contraccettive.
• Pazienti non disposti o non in grado di rispettare le regole del protocollo clinico.

E.5 End points

E.5.1

Primary end point(s)

TIL rate on residual disease after either IV trastuzumab or SC trastuzumab

Percentuale di TIL nel tessuto tumorale residuo dopo terapia neoadiuvante con trastuzumab EV o SC

E.5.1.1

Timepoint(s) of evaluation of this end point

After completion of neoadjuvant treatment

dopo completamento della terapia neoadiuvante

E.5.2

Secondary end point(s)

To evaluate associations between biomarkers (TILs , TLA, and Fc¿R polymorphisms)and between each biomarker with clinical outcome variables ; To evaluate safety and tolerability of each treatment regimen, including pre-operative (neoadjuvant) and post-operative (adjuvant) treatment. Toxicities will be graded according to the NCI CTCAE version 4.0 and reported as cumulative incidence; C. To evaluate HRQOL during study treatment based on FACT-B:
C1. Comparison between mean FACT-B scores assessed at enrolment and mean FACT-B scores assessed before surgery.
C2. Comparison between treatment arms of FACT-B scores assessed at predefined time points and expressed as the area under the curve (AUC).
; To describe prognostic aspects of each treatment regimen based on:
. Comparison of response rates between treatment arms:
• complete pathological response rate
• clinical response rate
• breast conserving surgery rate
; Comparison of median survival times between treatment arms:
• 5-year disease-free survival
• 5-year progression-free survival
• Time to clinical response

Valutazione dell’associazione tra biomarkers immunologici (TIL , TLA, polimorfismi dei geni Fc¿R) e le variabili di outcome clinico.; Valutazione della sicurezza e della tollerabilità di ciascun regime di trattamento, sia in fase pre-operatoria (neoadiuvante) che post-operatoria (adiuvante). Le tossicità saranno classificate secondo i criteri NCI CTCAE versione 4.0 e segnalate come incidenza cumulativa.; Valutazione della qualità di vita (HRQOL) durante il trattamento in studio basata sui questionari FACT-B:
• Confronto tra media dei punteggi FACT-B valutata al momento dell'arruolamento e punteggi medi FACT-B valutati prima dell'intervento chirurgico.
• Confronto tra i bracci di trattamento dei punteggi FACT-B valutati in momenti predefiniti ed espressi come area sotto la curva (AUC).
; • Confronto dei tassi di risposta tra i bracci di trattamento:
• Risposta patologica completa
• Risposta clinica
• Tasso di chirurgia conservativa del seno
; • Confronto dei tempi di sopravvivenza mediana tra i bracci di trattamento:
• Sopravvivenza libera da malattia (DFS) a 5 anni
• Sopravvivenza libera da progressione (PFS) a 5 anni
• Tempo alla risposta clinica

E.5.2.1

Timepoint(s) of evaluation of this end point

at baseline and on residual disease; at each visit and at the endo of study; at baseline, before and after surgery, each 3 months and at the end of study; before surgery, at the end of study treatment; every 6 months up to 5 years

al basale e nel tessuto tumorale residuo dopo terapia neoadiuvante; a ogni visita e a fine studio; al basale, prima della e dopo l'intervento, ogni 3 mesi e a fine studio; prima dell'intervento, alla fine del trattamento; ogni 6 mesi fino a 5 anni

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

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

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

stesso farmaco ma con diversa via di somministrazione

same drug with different administration way

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

stesso farmaco ma con diversa via di somministrazione

same drug with different administration way

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

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.7

Trial has a data monitoring committee

Yes

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 study will be five years after randomization of the last patient or progressive disease relapse experienced in all patients, whichever is earlier.

La fine dello studio sarà di cinque anni dopo la randomizzazione dell'ultimo paziente o recidiva o progressione in tutti i pazienti, se inferiore

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.1.1.1

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:

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

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

F.4.2.2

In the whole clinical trial

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)

Patients will be followed up until 5 years since enrollment, or earlier, in the case of withdrawal of consent, loss to follow-up, death, or study closure. Subjects will be treated as deemed appropriate by the investigator following the end of the study.

I pazienti saranno seguiti entro 5 anni dall’arruolamento. I soggetti saranno trattati come ritenuto opportuno dal ricercatore dopo la fine dello 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

2016-09-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-09-20

P. End of Trial
P.	End of Trial Status	Completed

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Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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