Clinical Trials Register

Summary
EudraCT Number:	2009-016879-29
Sponsor's Protocol Code Number:	IPR/22.D
National Competent Authority:	Sweden - MPA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2012-03-09
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

Sweden - MPA

A.2

EudraCT number

2009-016879-29

A.3

Full title of the trial

NGR015: Randomised double-blind phase III study of NGR-hTNF plus best investigator's choice (BIC) versus placebo plus BIC in previously treated patients with advanced malignant pleural mesothelioma (MPM)

A.3.1

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

Study of efficacy and safety of the compound NGR-hTNF in patient with advanced malignant pleural mesothelioma

A.3.2

Name or abbreviated title of the trial where available

NGR015

A.4.1

Sponsor's protocol code number

IPR/22.D

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	MOLMED
B.1.3.4	Country	Italy
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	MOLMED SPA
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	Innopharma Srl
B.5.2	Functional name of contact point	Clinical Project Manager
B.5.3	Address:
B.5.3.1	Street Address	via Lavoratori Autobianchi 1
B.5.3.2	Town/ city	Desio (MB)
B.5.3.3	Post code	20832
B.5.3.4	Country	Italy
B.5.4	Telephone number	+39362573128
B.5.5	Fax number	+39362544211
B.5.6	E-mail	d.scanniffio@innopharma.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	No
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/3/08/549
D.3 Description of the IMP
D.3.1	Product name	NGR-hTNF
D.3.2	Product code	MM102
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	NA
D.3.9.1	CAS number	NA
D.3.9.2	Current sponsor code	MM102
D.3.9.3	Other descriptive name	NA
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	200
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	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	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	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
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	DOXORUBICIN
D.3.2	Product code	DOXORUBICIN
D.3.4	Pharmaceutical form	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	Doxorubicin
D.3.9.1	CAS number	NA
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	NA
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	2
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	anthracycline
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.2.5	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	gemcitabine
D.3.4	Pharmaceutical form	Powder 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	gemcitabine
D.3.9.1	CAS number	NA
D.3.9.2	Current sponsor code	NA
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	200 to 1000
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	pyrimidine analog
D.IMP: 4
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.2.5	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	vinorelbine
D.3.4	Pharmaceutical form	Capsule, soft
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Vinorelbine
D.3.9.1	CAS number	NA
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	NA
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	10 to 50
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	vinca alKaloid

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Concentrate for solution for infusion
D.8.4	Route of administration of the placebo	Intravenous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Advanced malignant pleural mesothelioma previuosly treated with a pemetrexed based chemotherapy regimen

Avancerat MPM tidigare behandlat med en pemetrexed-baserad kemoterapiregim

E.1.1.1

Medical condition in easily understood language

Patient suffering from pleural cancer (pleural mesothelioma) that have already received chemotherapy (not more than 1 treatment with the "pemetrexed" chemotherapy)

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	10035605
E.1.2	Term	Pleural mesothelioma malignant advanced
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

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

To compare overall survival (OS) in patients randomized to NGR-hTNF plus BIC versus patients randomized to placebo plus BIC

Att jämföra total överlevnad (overall survival, OS) hos patienter randomiserade till NGR-hTNF plus BIC kontra patienter randomiserade till placebo plus BIC

E.2.2

Secondary objectives of the trial

-To compare progression-free survival (PFS)
-To compare disease control rate (DCR, defined as the percentage of patients who have a best response rating of complete or partial response or stable disease, according to MPM-modified RECIST criteria)
-To compare duration of disease control
-To evaluate safety and toxicity profile related to NGR-hTNF
-To assess changes in quality of life (QoL) in the two treatment arms
-To evaluate medical care utilization in the two treatment arms

•Att jämföra progressionsfri överlevnad (progression-free survival, PFS)
•Att jämföra frekvens för sjukdomskontroll (disease control rate, DCR; definierad som procentuell andel patienter som har klassats som bästa respons av komplett eller partiell respons eller stabil sjukdom, enligt MPM-modifierade RECIST-kriterier)
•Att jämföra duration av sjukdomskontroll
•Att utvärdera säkerhets- och toxicitetsprofil för NGR-hTNF
•Att bedöma förändringar i livskvalitet (Quality of Life, QoL) i de två behandlingsarmarna
•Att utvärdera utnyttjandet av medicinsk vård i de två behandlingsarmarna

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

Substudy A: "Substudy for vinorelbine administration" - 20 JAN 2010 version B
Objective: check the safety of the potential combination of NGR-hTNF with Vinorelbine

Substudy B: "Quality of Life Assessment" - 20 JAN 2010 version B
Objective: Assessment of the social wellbeing of the patient

Substudy C: "Medical Resource utilisation" - 20 JAN 2010 version B
Objective: Health Economic analyses

Delstudie A: "Delstudie för administrering av vinorelbin" (För att kunna kontrollera säkerheten av den potentiella kombinationen NGR-hTNF och vinorelbin )
Delstudie B: "Livskvalitet"
Delstudie C: "Utnyttjande av medicinska resurser" (hälsoekonomiska analyser)

E.3

Principal inclusion criteria

1.Age ≥ 18 years
2. Histologically or cytological confirmed malignant pleural mesothelioma of any of the following subtype:
epithelial, sarcomatoid, mixed, or unknown
3. Prior treatment with no more than one sistemic pemetrexed-based chemotherapy regimen administered
for advanced or metastatic disease. Prior use of a biological agent in combination with a pemetrexed based
regimen and prior administration of intrapleural cytotoxic agents are allowed.Patients who have previously received anthracyclines should not receive doxorubicin.
4. ECOG Performance Status 0 - 2
5. Life expectancy of ≥12 weeks
6. Adequate baseline bone marrow, hepatic and renal function, defined as follows:
a. Neutrophils ≥ 1.5 x 109/L; platelets ≥ 100 x 109/L; hemoglobin ≥ 9 g/dL
b. Bilirubin ≤ 1.5 x ULN
c. AST and/or ALT ≤ 2.5 x ULN in absence of liver metastasis or ≤ 5 x ULN in presence of liver metastasis
d. Serum creatinine < 1.5 x ULN
7. Measurable or non-measurable disease according to MPM-modified RECIST criteria
8. Patients may have had prior therapy providing the following conditions are met:
a. Surgery: wash-out period of 14 days
b.Systemic anti-tumor and radiation therapy: wash-out period of 28 days
9. Patients must give written informed consent to participate in the study

1.Ålder ≥ 18 år
2.Histologiskt eller cytologiskt bekräftat malignt pleuralt mesoteliom av någon av följande subtyper: epitelial, sarkomatös, blandad, eller okänd
3.Tidigare behandling med endast en systemisk pemetrexedbaserad kemoterapiregim administrerad för avancerad eller metastatisk sjukdom. Tidigare användning av ett biologiskt medel i kombination med en pemetrexedbaserad regim och tidigare administrering av intrapleurala cytotoxiska medel är tillåten. Patienter som tidigare har erhållit antracykliner ska inte ges doxorubicin.
4.ECOG prestandastatus 0 - 2
5.Sannolik livslängd ≥ 12 veckor
6.Tillfredsställande benmärg, lever- och njurfunktion vid baslinje definierat enligt följande:
a.Neutrofiler ≥ 1,5 x 109/L; trombocyter ≥ 100 x 109/L; hemoglobin ≥ 90 g/L
b.Bilirubin ≤ 1,5 x ULN
c.AST och/eller ALT ≤ 2,5 x ULN i frånvaro av levermetastaser eller ≤ 5 x ULN i närvaro av evermetastaser
d.Serumkreatinin < 1,5 x ULN
7.Mätbar eller icke mätbar sjukdom enligt MPM-modifierade RECIST-kriterier
8.Patienter kan ha fått tidigare behandling under förutsättning att följande villkor uppfylls:
a.Operation: “wash-out”-period på 14 dagar
b.Systemisk antitumör- och strålbehandling: “wash-out”-period på 28 dagar
9.Patienter måste ge skriftligt informerat samtycke till att delta i studien

E.4

Principal exclusion criteria

1. Patients must not receive any other investigational agents while on study
2. Patients with myocardial infarction within the last six months, unstable angina, New York Heart association (NYHA) grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication
3. Uncontrolled hypertension
4. QTc interval (congenital or acquired) > 450 ms
5. History or evidence upon physical examination of CNS disease unless adequately treated (e.g., primary brain tumor, any brain metastasis, seizure not controlled with standard medical therapy, or history of stroke)
6. Patients with active or uncontrolled systemic disease/infections or with serious illness or medical conditions, which is incompatible with the protocol
7. Known hypersensitivity/allergic reaction to human albumin preparations or to any of the excipients
8. Any psychological, familial, sociological or geographical condition potentially tampering compliance with the study protocol
9. Pregnancy or lactation.

1.Patienterna får inte behandlas med några andra undersökande medel under studiens gång
2.Patienter med hjärtinfarkt de senaste sex månaderna, instabil angina, New York Heart Association (NYHA) grad II eller mer uttalad hjärtsvikt, eller allvarlig kardiell arytmi som kräver läkemedelsbehandling
3.Okontrollerad hypertoni
4.QTc-intervall (kongenital eller förvärvad) > 450 ms
5.Anamnes eller tecken vid kroppsundersökning på CNS-sjukdom om inte tillfredsställande behandlat (t.ex. primär hjärntumör, alla hjärnmetastaser, epilepsi som inte kontrolleras med vanlig medicinsk behandling, eller anamnes på stroke)
6.Patienter med aktiv eller okontrollerad systemisk sjukdom/infektioner eller med allvarlig sjukdom eller medicinska tillstånd, vilka är oförenliga med protokollet
7.Känd överkänslighet/allergisk reaktion på humana albuminberedningar eller på någon av beståndsdelarna
8.Alla psykologiska, familjära, sociologiska eller geografiska tillstånd som potentiellt kan hindra följsamhet med studieprotokollet
9.Graviditet eller amning

E.5 End points

E.5.1

Primary end point(s)

To compare overall survival (OS) in patients randomised to NGR-hTNF plus BIC (Best Investigator Choice) versus patients randomised to placebo plus BIC.

Att jämföra total överlevnad (overall survival, OS) hos patienter randomiserade till NGR-hTNF plus BIC (best investigator’s choice, BIC) kontra patienter randomiserade till placebo plus BIC

E.5.1.1

Timepoint(s) of evaluation of this end point

Time from the date of randomization until the date of death due to any cause or the last date the patient was known to be alive.

Tid från och med dagen för randomisering till dödsdagen till någon orsak eller två sista dagen patienten var känd för att vara vid liv.

E.5.2

Secondary end point(s)

- Progression-free survival (PFS)
- Disease control rate (DCR)
- Duration of disease control
- Safety
- Quality of life (QoL)
- Medical Care Utilization (MCU)

- Progressionsfri överlevnad (PFS)
- Frekvensen för sjukdomskontroll (DCR)
- Duration av sjukdomskontroll
- Säkerhet och tolerans
- Livskvalitet
- Utnyttjande av medicinska resurser

E.5.2.1

Timepoint(s) of evaluation of this end point

- Progression-free survival (PFS): time from the date of randomization until disease progression, or death due to any cause

Tid från och med dagen för randomisering till dödsdagen till någon orsak eller två sista dagen patienten var känd för att vara vid liv.

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

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

Yes

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Quality of Life assessment

livskvalitet bedöma

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

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

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)

E.8.2.2

Placebo

Yes

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

Yes

E.8.4

The trial involves multiple sites in the 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

Egypt

United States

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 corresponds to the date of close-out visit in the last centre. In fact, study data will be validated and study documents will be reviewed within close-out visit.

Slutet av studien motsvarar den sista dagen av sista besök i centrum.

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:

390

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

390

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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2012-03-09.

Yes

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

192

F.4.2.2

In the whole clinical trial

390

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 the study partecipation, patient will be treated according to the best choice of the investigator. No reccomandations in regards is mentioned in the protocol

Bästa undersökares val (BIC)

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

2012-04-27

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-04-18

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2017-12-18

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IMP with orphan designation in the indication
Orphan Designation Number:
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