Clinical Trials Register

Summary
EudraCT Number:	2012-001580-68
Sponsor's Protocol Code Number:	RoCHOP
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2013-06-25
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

2012-001580-68

A.3

Full title of the trial

Phase 3 Multi-Center Randomized Study to Compare Efficacy and Safety of Romidepsin¬ CHOP (Ro-CHOP) versus CHOP in subjects with Previously Untreated Peripheral T-Cell Lymphoma.

Studio randomizzato multicentrico di fase III: confronto in termini di efficacia e sicurezza della Romidepsina in combinazione con il regime CHOP (Ro-CHOP) vs CHOP da solo nel trattamento di linfomi T periferici in pazienti non precedentemente trattati.

A.3.1

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

Multi-Center Randomized Study to Compare Efficacy and Safety of Romidepsin¬ CHOP (Ro-CHOP) versus CHOP in subjects with Previously Untreated Peripheral T-Cell Lymphoma.

A.3.2

Name or abbreviated title of the trial where available

RoCHOP

A.4.1

Sponsor's protocol code number

RoCHOP

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	LYSARC
B.1.3.4	Country	France
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	Celgene
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	LYSARC
B.5.2	Functional name of contact point	Stéphanie PICARD
B.5.3	Address:
B.5.3.1	Street Address	LYSARC - CH Lyon Sud -Secteur Sainte Eugénie - Pavillon 6D
B.5.3.2	Town/ city	Pierre Bénite Cedex
B.5.3.3	Post code	69495
B.5.3.4	Country	France
B.5.4	Telephone number	330472 66 93 33
B.5.5	Fax number	330426 07 40 13
B.5.6	E-mail	stephanie.picard@lysarc.org

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	Istodax
D.2.1.1.2	Name of the Marketing Authorisation holder	Celgene
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	Yes
D.2.5.1	Orphan drug designation number	EU/3/05/328
D.3 Description of the IMP
D.3.1	Product name	romidepsin
D.3.2	Product code	FK228
D.3.4	Pharmaceutical form	Powder and solvent 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	ROMIDEPSIN
D.3.9.1	CAS number	128517-07-7
D.3.9.4	EV Substance Code	SUB26362
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	5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	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

Peripheral T-Cell Lymphoma

Linfoma a cellule T periferico

E.1.1.1

Medical condition in easily understood language

Lymphoma

Linfoma

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	14.1
E.1.2	Level	PT
E.1.2	Classification code	10034623
E.1.2	Term	Peripheral T-cell lymphoma unspecified
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

The primary objective of the study is to compare efficacy of romidepsin when administered with CHOP versus CHOP alone in subjects with previously untreated peripheral T-cell lymphoma (PTCL)

: L’obiettivo primario dello studio è confrontare l’efficacia della Romidepsina somministrata in combinazione con CHOP vs CHOP da solo, in soggetti affetti da linfoma T periferico (PTCL)

E.2.2

Secondary objectives of the trial

The secondary objectives are to compare Ro-CHOP and CHOP alone in terms of:
• Overall survival
• Overall Response Rate (ORR [PR+CR+CRu]) (according to the Response criteria for malignant lymphoma 1999)
• Duration of response
• Time to progression
• Time to treatment failure
• Safety
• Quality of Life (QoL)
• Response rates by PTCL histological subtypes
• Response rate by standard prognostic parameters

il confronto tra Ro-CHOP e CHOP da solo in termini di:

• Sopravvivenza globale (OS)
• Tassi di risposta globale (ORR [PR+CR+CRu] (secondo i criteri di risposta per linfoma maligno 1999).
• Durata della risposta
• Tempo alla progressione
• Tempo all’insuccesso
• Sicurezza
• Qualità della vita (QoL)
• Tassi di risposta in base ai sottotipi istologici PTCL
• Tasso di risposta in base ai parametri prognostici standard

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Patients must satisfy all following criteria to be enrolled in the study:
1. Males and females of 18 years of age to 80 years of age.
2. Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted.
3. Able to adhere to the study visit schedule and other protocol requirements.
4. Patients with histologically proven peripheral T-cell lymphoma (PTCL), not previously treated; the following subtypes as defined by the WHO classification (2008;2011) may be included, whatever the Ann Arbor stage (l-lV):
a. Nodal types:
i. PTCL, not otherwise specified
ii. Angioimmunoblastic T-cell lymphoma
iii. Anaplastic large cell lymphoma, ALK-negative type

b. Extra-nodal types:
i. Enteropathy-associated T-cell lymphoma
ii. Hepato-splenic T-cell lymphoma
iii. Subcutaneous panniculitis-like T-cell lymphoma
iv. Primary cutaneous gamma-delta T-cell lymphoma
v. Primary cutaneous CD8+ aggresive epidermotropic lymphoma
vi. Primary cutaneous CD4+ small/medium T-cell lymphoma
c. Other non classifiable peripheral T-cell lymphoma
5. ECOG performance status 0, 1 or 2
6. Negative pregnancy test for females of childbearing potential (FCBP)
7. Female patients of child bearing potential must use an effective method of birth control (i.e. hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide or abstinence) during treatment period and 1 month thereafter; Males must use an effective method of birth control during treatment period and 3 months thereafter.
8. Life expectancy of ≥ 90 days (3 months).

1. Età compresa tra 18 e 80 anni
2. Firma del consenso informato (spontaneamente e in piena coscienza) prima che vengano condotte valutazioni e procedure relative allo studio.
3. In grado di aderire al programma di visite e altri requisiti del protocollo
4. Pazienti non precedentemente trattati con diagnosi istologica di linfoma T periferico (PTCL); i seguenti sottotipi, come definito dalla classificazione WHO (2008;2011) possono essere inclusi, qualunque sia lo stadio di Ann Arbor (I-IV):
a. Forme nodali
i. PTCL, non diversamente specificato
ii. Linfoma angioimmunoblastico a cellule T
iii. Linfoma a grandi cellule anaplastico, tipo ALK-negativo
b. Forme extranodali
i. Linfoma T associato ad enteropatia
ii. Linfoma epato-splenico a cellule T
iii. Linfoma a cellule T sottocutaneo tipo pannicolite
iv. Linfoma cutaneo primario a cellule T delta
v. Linfoma cutaneo primario CD8+ aggressivo epidermotropico
vi. Linfoma cutaneo primario a cellule T medio-piccole CD4+
c. Altri linfomi periferici a cellule T non classificabili
5. ECOG performance status 0, 1 o 2
6. Test di gravidanza negativo per le donne in età fertile
7. Le donne in età fertile devono utilizzare un metodo efficace di controllo delle nascite (ad esempio contraccettivi ormonali, dispositivo intrauterino, diaframma con spermicida, preservativo con spermicida o astinenza) durante il periodo di trattamento e nel 1° mese successivo; i pazienti di sesso maschile devono usare un efficace metodo di controllo delle nascite durante il periodo di trattamento e nei 3 mesi successivi.
8. Aspettativa di vita ≥ 90 giorni (3 mesi)

E.4

Principal exclusion criteria

The presence of any of the following will exclude a patient from enrollment:
1. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from participating in the study.
2. Any condition that confounds the ability to interpret data from the study.
3. Other types of lymphomas, e.g. B-cell lymphoma.
4. The following types of T cell lymphomas:
a. Adult T-cell lymphoma/leukemia (HTLV-1 related T-cell lymphoma)
b. Extranodal T-cell/NK-cell lymphoma, nasal type
c. Anaplastic large cell lymphoma, ALK-positive type
d. Cutaneous T cell lymphoma (mycosis fungoides, Sézary syndrome)
e. Primary cutaneous CD30+ T-cell lymphoproliferative disorder
f. Primary cutaneous anaplastic T-cell lymphoma
5. Previous treatment for PTCL with immunotherapy or chemotherapy except for short-term corticosteroids (duration of <=8 days) before randomization.
6. Previous radiotherapy for PTCL except if localized to one lymph node area.
7. Patients planned for autologous or allogeneic transplant as consolidation in first line.
8. Central nervous system-meningeal involvement
9. Contraindication to any drug contained in the chemotherapy regimen.
10. Subjects with HIV positivity.
11. Subjects with active hepatitis B or C. Chronic carriers of hepatitis B without HBV DNA positive blood are eligible. Subjects with non-active hepatitis C (with normal transaminases) are eligible.
12. Any of the following laboratory abnormalities, except if secondary to the lymphoma:
a. Absolute neutrophil count (ANC) < 1,500 cells/mm3 (1.5 x 109/L),
b. Platelet count < 100,000/mm3 (100 x 109/L), or < 75,000/mm3 if bone marrow is involved,
c. Serum SGOT/AST or SGPT/ALT ≥ 3.0 x upper limit of normal (ULN),
d. Serum total bilirubin > 2 x ULN, except in case of hemolytic anemia,
e. K+ and Mg2+ levels < LLN, except if corrected per protocol guidance before beginning the romidepsin infusion.
13. Serum creatinine > 2.0 x ULN
14. Prior history of malignancies other than lymphoma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast or untreated prostatic cancer without any plan for a treatment) unless the patient has been free of the disease for ≥ 3 years
15. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing the informed consent form
16. Any known cardiac abnormalities such as:
a. Patients with congenital long QT syndrome,
b. Corrected QT interval > 480 msec (using the Fridericia formula),
c. Myocardial infarction within 6 months of cycle 1 day 1,
d. History of or concomitant significant cardiovascular disease,
e. Ejection fraction <45% by MUGA scan or by echocardiogram.
17. Concomitant use of drugs that may cause a significant prolongation of the QTc.
18. Patients who have received more than 200 mg/m2 doxorubicin.
19. Concomitant use of strong CYP3A4 inhibitors (see Appendix)
20. Concomitant use of therapeutic warfarin due to a potential drug interaction. Use of a low dose of warfarin or another anticoagulant to maintain patency of venous access port and cannulas is permitted.
21. Clinically significant active infection.
22. Use of any standard or experimental anti-cancer drug therapy within 28 days of the initiation (Day 1) of study drug.
23. Pregnant or lactating females or women of childbearing potential not willing to use an adequate method of birth control for the duration of the study.

1. Qualsiasi condizione medica significativa, alterazione di laboratorio o malattia psichiatrica, che potrebbe impedire al paziente di partecipare allo studio
2. Qualsiasi condizione che confonde la capacità di interpretare i dati dello studio
3. Altre tipologie di linfoma, quali ad esempio Linfoma a cellule B
4. I seguenti tipi di linfoma T:
a. Linfoma a cellule T dell'adulto/Leucemia (HTLV-1 related T-cell lymphoma)
b. Linfoma extranodale a cellule NK/T di tipo nasale
c. Linfoma anaplastico a grandi cellule, tipo ALK-positivo
d. Linfoma cutaneo a cellule T (micosi fungoide, sindrome di Sézary)
e. Disordine linfoproliferativo primario della cute a cellule T CD30+
f. Linfoma cutaneo primario anaplastico a cellule T
5. Precedente trattamento per PTCL con immunoterapia o chemioterapia fatta eccezione per i corticosteroidi nel breve periodo (durata ≤ 8 giorni) prima della randomizzazione
6. Precedente radioterapia per PTCL tranne se localizzata a una sola stazione linfonodale
7. Pazienti programmati per il trapianto autologo o allogenico come consolidamento in prima linea
8. Coinvolgimento meningeo del sistema nervoso centrale
9. Controindicazione a qualsiasi farmaco contenuto nel regime chemioterapico
10. Sierologia positiva per HIV
11. Soggetti con epatite B o C attiva. I portatori cronici di epatite B senza positività HBV DNA nel sangue sono elegibili. I soggetti con epatite C non attiva (con transaminasi normali) sono elegibili
12. Una qualsiasi delle seguenti anomalie di laboratorio, salvo se secondaria rispetto al linfoma:
a. Conta assoluta dei neutrofili (ANC) < 1,500 cellulle/mm³ (1.5 x 109/L),
b. Conta delle piastrine <100,000/ mm³ (100 x 109/L), o <75.000/ mm³, se il midollo osseo è coinvolto,
c. SGOT/AST o SGPT/ALT ≥ 3.0 x limite superiore di normalità (ULN),
d. Bilirubina totale > 2 x ULN, salvo in caso di anemia emolitica
e. Livelli di K+ e Mg2+ < LLN, tranne se corretto per indicazione del protocollo prima di iniziare l'infusione di Romidepsina
13. Creatinina serica > 2.0 x ULN
14. Precedente storia di tumori diversi dal linfoma (ad eccezione del carcinoma della pelle a cellule basali o a cellule squamose o carcinoma della cervice o del seno in situ o tumore alla prostata non trattato, senza alcun piano di trattamento) a meno che il paziente sia stato libero da malattia per un periodo di tempo superiore o pari a 3 anni.
15. Qualsiasi condizione medica grave, alterazione di laboratorio o malattia psichiatrica, che possa impedire al paziente di firmare il modulo di consenso informato
16. Eventuali anomalie cardiache note quali:
a. Pazienti con sindrome congenita del QT lungo
b. Intervallo QT corretto > 480msec (utilizzando la formula di Fridericia)
c. Infarto miocardico nei 6 mesi precedenti al ciclo 1 giorno 1
d. Storia di concomitante significativa malattia cardiovascolare
e. Frazione di eiezione <45% misurata con MUGA scan o ecocardiogramma;
17. L'uso concomitante di farmaci che possono provocare un significativo prolungamento del QTc
18. Pazienti che hanno ricevuto più di 200 mg/m2 di Doxorubicina
19. Uso concomitante di potenti inibitori del CYP3A4
20. Uso concomitante di Warfarin terapeutico per evitare una potenziale interazione farmacologica. È permesso l’uso di una bassa dose di Warfarin o di un altro anticoagulante per mantenere la pervietà dell’accesso venoso o delle cannule.
21. Infezione attiva clinicamente significativa
22. Uso di qualsiasi terapia farmacologica antitumorale standard o sperimentale entro 28 giorni dall’inizio del trattamento (Giorno 1)
23. Donne in gravidanza o in fase di allattamento o donne in età fertile non disposte a utilizzare un adeguato metodo contraccettivo per tutta la durata dello studio.

E.5 End points

E.5.1

Primary end point(s)

Progression-free survival (PFS) assessed according to Response criteria for malignant lymphoma 1999 by a Response adjudication committee.

Sopravvivenza libera da progressione (PFS) stimata secondo i Criteri di risposta per il linfoma maligno del 1999, del Response Adjudication Committee (RAC)

E.5.1.1

Timepoint(s) of evaluation of this end point

Tumor assessment (clinical examination, laboratory tests, pelvis, abdominal, chest and cervical CT scan, bone marrow examination) will be performed at baseline, at mid-treatment after 3 cycles (CT scan only) and 4 weeks after the last treatment dose. To ensure comparability, baseline and on-study methods for response assessment will be performed using identical techniques.
Follow-up assessment, including CT Scan, will be clinical visit every 3 months the first year, then every 4 months the 2nd year, and every 6 months thereafter.

Una valutazione del tumore (esame clinico, esami di laboratorio, TC di bacino, addome, torace, cervice, esame del midollo osseo) verrà eseguita al basale, dopo 3 cicli di trattamento (solo una TC) e 4 settimane dopo l'ultima dose di trattamento.
Per garantire la comparabilità, le indagini basali e le rivalutazioni in corso di studio saranno eseguite utilizzando tecniche identiche.
Follow-up di valutazione, tra cui TC, visita clinica ogni 3 mesi il primo anno, poi ogni 4 mesi il secondo anno, e in seguito ogni 6 mesi.

E.5.2

Secondary end point(s)

• Overall survival
• Overall Response Rate (ORR [PR+CR+CRu]) (according to the Response criteria for malignant lymphoma 1999)
• Duration of response
• Time to progression
• Time to treatment failure
• Safety
• Quality of Life (QoL)
• Response rates by PTCL histological subtypes
• Response rate by standard prognostic parameters

• • Sopravvivenza globale (OS)
• Tassi di risposta globale (ORR [PR+CR+CRu] (secondo i criteri di risposta per linfoma maligno 1999).
• Durata della risposta
• Tempo alla progressione
• Tempo all’insuccesso
• Sicurezza
• Qualità della vita (QoL)
• Tassi di risposta in base ai sottotipi istologici PTCL
• Tasso di risposta in base ai parametri prognostici standard

E.5.2.1

Timepoint(s) of evaluation of this end point

• Overall survival: 2 years after the end of treatment
• Overall Response Rate (ORR [PR+CR+CRu]): at the end of treatment
• Duration of response: all duration of the study
• Time to progression: all duration of the study
• Time to treatment failure: all duration of the study
• Safety: all duration of the study
• Quality of Life (QoL) :At randomization, at D1 of cycle 4, at evaluation at the end of treatment, and during follow-up every 3 months the first year, every 4 months the second year and every year during follow-up period until primary analysis
• Response rates by PTCL histological subtypes:at the end of treatment
• Response rate by standard prognostic parameters: at the end of treatment

• • Sopravvivenza globale (OS): 2 anni dopo la fine del trattamento
• Tassi di risposta globale (ORR [PR+CR+CRu] : alla fine del trattamento
• Durata della risposta: tutta la durata dello studio
• Tempo alla progressione: tutta la durata dello studio
• Tempo all’insuccesso: tutta la durata dello studio
• Sicurezza: tutta la durata dello studio
• Qualità della vita (QoL): alla randomizzazione al giorno 1 del ciclo 4, alla valutazione alla fine dello studio, durante il follow up ogni 3 mesi il primo anno, ogni 4 masi il secondo anno e ogni anno durante il follow up fino all’analisi primaria
• Tassi di risposta in base ai sottotipi istologici PTCL: alla fine del trattamento
• Tasso di risposta in base ai parametri prognostici standard: alla fine del 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

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

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)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

association of romidepsin and CHOP versus CHOP alone

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

120

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

Korea, Democratic People's Republic of

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 the trial will be the end of follow up so approximately 6 years after the last patient randomized.

La fine dello studio corrisponderà con la fine del follow up, quindi approssimativamente 6 anni dopo la randomizzazione dell’ultimo paziente.

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

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:

120

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

300

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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

180

F.4.2

For a multinational trial

F.4.2.1

In the EEA

300

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)

no difference

Nessuna differenza

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

2013-09-12

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-12-10

P. End of Trial
P.	End of Trial Status	Ongoing

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