Clinical Trials Register

Summary
EudraCT Number:	2015-000640-42
Sponsor's Protocol Code Number:	1199.222
National Competent Authority:	France - ANSM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2015-08-05
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

France - ANSM

A.2

EudraCT number

2015-000640-42

A.3

Full title of the trial

A twelve week, open-label, randomised, parallel-group study evaluating safety, tolerability and pharmacokinetics (PK) of oral nintedanib in combination with oral pirfenidone, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF)

Étude randomisée, réalisée en ouvert sur des groupes parallèles, comparant l’innocuité, la tolérance et la pharmacocinétique (PK) du nintedanib associé à la pirfénidone administrés par voie orale à celles du nintedanib administré seul, pendant 12 semaines de traitement chez des patients atteints de fibrose pulmonaire idiopathique (FPI)

A.3.1

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

Safety, tolerability and PK of nintedanib in combination with pirfenidone in IPF

Innocuité, tolérance et pharmacocinétique (devenir du médicament après son administration dans le corps) du traitement combiné nintedanib et pirfénidone chez les patients atteints de fibrose pulmonaire idiopathique

A.3.2

Name or abbreviated title of the trial where available

Safety, tolerability and PK of nintedanib in combination with pirfenidone in IPF

Innocuité, tolérance et PK du nintedanib combiné avec la pirfénidone dans la PFI

A.4.1

Sponsor's protocol code number

1199.222

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	Boehringer Ingelheim France
B.1.3.4	Country	France
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	Boehringer Ingelheim France
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Boehringer Ingelheim
B.5.2	Functional name of contact point	QRPE PSC CT Information Disclosure
B.5.3	Address:
B.5.3.1	Street Address	Binger Strasse 173
B.5.3.2	Town/ city	Ingelheim am Rhein
B.5.3.3	Post code	55216
B.5.3.4	Country	Germany
B.5.4	Telephone number	+18002430127
B.5.5	Fax number	+18008217119
B.5.6	E-mail	clintriage.rdg@boehringer-ingelheim.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	Yes
D.2.1.1.1	Trade name	Ofev
D.2.1.1.2	Name of the Marketing Authorisation holder	Boehringer Ingelheim International GmbH
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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/3/13/1123
D.3 Description of the IMP
D.3.1	Product name	Ofev 100 mg capsule
D.3.2	Product code	nintedanib
D.3.4	Pharmaceutical form	Capsule, soft
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	nintedanib
D.3.9.1	CAS number	656247-17-5
D.3.9.3	Other descriptive name	NINTEDANIB
D.3.9.4	EV Substance Code	SUB120728
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	100
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	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	Ofev
D.2.1.1.2	Name of the Marketing Authorisation holder	Boehringer Ingelheim International GmbH
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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/3/13/1123
D.3 Description of the IMP
D.3.1	Product name	Ofev 150 mg capsule
D.3.2	Product code	nintedanib
D.3.4	Pharmaceutical form	Capsule, soft
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	nintedanib
D.3.9.1	CAS number	656247-17-5
D.3.9.3	Other descriptive name	NINTEDANIB
D.3.9.4	EV Substance Code	SUB120728
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.3.11 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.2.1.1.1	Trade name	Esbriet
D.2.1.1.2	Name of the Marketing Authorisation holder	Roche Registration Limited
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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/3/04/241
D.3 Description of the IMP
D.3.1	Product name	pirfenidone
D.3.2	Product code	pirfenidone
D.3.4	Pharmaceutical form	Capsule, hard
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	PIRFENIDONE
D.3.9.1	CAS number	53179-13-8
D.3.9.2	Current sponsor code	PIRFENIDONE
D.3.9.3	Other descriptive name	PIRFENIDONE
D.3.9.4	EV Substance Code	SUB09907MIG
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	267
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

Idiopathic Pulmonary Fibrosis

Fibrose Pulmonaire Idiopathique

E.1.1.1

Medical condition in easily understood language

Idiopathic pulmonary fibrosis
N/A

Fibrose Pulmoniare Idiopathique
N/A

E.1.1.2

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	18.0
E.1.2	Level	PT
E.1.2	Classification code	10021240
E.1.2	Term	Idiopathic pulmonary fibrosis
E.1.2	System Organ Class	10038738 - Respiratory, thoracic and mediastinal disorders

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

The main objective of the trial will be to assess safety and tolerability of combined treatment with nintedanib and pirfenidone

L’objectif principal de l’étude est d’évaluer l’innocuité et la tolérance du traitement combiné par le nintedanib et la pirfénidone.

E.2.2

Secondary objectives of the trial

A secondary objective is to assess the exposure, based on pharmacokinetic trough concentration values, to nintedanib either given alone or in combination with pirfenidone and to assess the assess the exposure of pirfenidone when combined with nintedanib

L’objectif secondaire est d’évaluer l’exposition au nintedanib en se basant sur les concentrations minimales de celui-ci, administré seul ou en association avec la pirfénidone et d’évaluer l’exposition à la pirfénidone en association avec le nintedanib.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

-Written informed consent consistent with ICH-GCP and local laws, signed prior to any study procedures being performed (including any required washout)
-Male or female patients aged greater than or equal to 40 years at visit 1
-Idiopathic Pulmonary Fibrosis (IPF) diagnosis, based upon the ATS/ERS/JRS/ALAT 2011 guideline and confirmed by the investigator based on chest high resolution computed tomography (HRCT) scan performed within 12 months of visit 1
-FVC greater than or equal to 50% of predicted normal at visit 1

1. Consentement éclairé signé conformément aux directives BPC-ICH et à la législation locale avant la participation à l'étude y compris toute période de wash-out requise.
2. Patient de sexe masculin ou féminin, âgés de 40 ans au moins lors de la visite 1.
3. Diagnostic de FPI selon les directives de l’ATS/ERS/JRS/ALAT 2011 et confirmé par un examen tomodensitométrique à haute résolution du thorax (HRCT), réalisé dans les 12 mois précédant la visite 1.
4. FVC ≥ 50% de la valeur normale théorique à la visite 1.

E.4

Principal exclusion criteria

-ALT, AST > 1.5 fold upper limit of normal (ULN) at visit 1
-Total bilirubin > 1.5 fold ULN at visit 1
-Relevant airways obstruction (i.e. pre-bronchodilator FEV1/FVC <0.7) at visit 1
-History of myocardial infarction within 6 months of visit 1 or unstable angina within 1 month of visit 1
-Bleeding Risk: Known genetic predisposition to bleeding, Patients who require fibrinolysis, full-dose therapeutic anticoagulation (e.g. vitamin K antagonists, dabigatran, heparin, hirudin etc) or high dose antiplatelet therapy, History of haemorrhagic central nervous system event within 12 months prior to visit 1, History of haemoptysis or haematuria, active gastro-intestinal bleeding or ulcers and/or major injury or surgery within 3 months prior to visit 1, International normalised ratio (INR) > 2 at visit 1, Prothrombin time and partial thromboplastin time (PTT) > 150% of
institutional ULN at visit 1
-Planned major surgery during the trial participation, including lung transplantation,major abdominal or major intestinal surgery.
-History of thrombotic event (including stroke and transient ischemic attack) within 12
months of visit 1
-History of end-stage renal disease requiring dialysis
-Treatment with NAC, prednisone >15 mg daily or >30 mg every 2 days OR equivalent
dose of other oral corticosteroids and/or fluvoxamine within 2 weeks of visit 2
-Treatment with azathioprine, cyclophosphamide, cyclosporine as well as any other
investigational drug within 8 weeks of visit 2
-Previous treatment with pirfenidone
-Permanent discontinuation of nintedanib in the past due to AEs considered drug-related
-Known hypersensitivity to nintedanib, pirfenidone, peanut or soya or to any of the
excipients
-A disease or condition which in the opinion of the investigator may interfere with testing procedures or put the patient at risk when participating in this trial
-Alcohol or drug abuse which in the opinion of the treating physician would interfere with treatment
-Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
-Women of childbearing potential not willing or able to use highly effective methods of
birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year
when used consistently and correctly5 for 28 days prior to and 3 months after nintedanib administration
-Patients not able to understand and follow study procedures including completion of selfadministered questionnaires without help
-Patients who require dose reduction and/or temporary interruption during the run-in
period with nintedanib 150 mg bid

1. ALT, AST > 1,5 fois la limite supérieure de la normale (LSN) à la visite 1
2. Bilirubine totale > 1,5 fois la LSN à la visite 1.
3. Obstruction importante des voies aériennes (c-à-d rapport VEMS/CV < 0,7 avant l’administration d’un bronchodilatateur) à la visite 1.
4. Antécédents d’infarctus du myocarde au cours des 6 mois précédant la visite 1 ou d’angor instable au cours du mois précédant la visite 1.
5. Risque hémorragique :
• Prédisposition génétique connue aux hémorragies
• Patients requérant une fibrinolyse, un traitement anticoagulant à dose thérapeutique complète (par ex. Antivitamines K, dabigatran, héparine, hirudine, etc.) ou un traitement anti-agrégant plaquettaire à forte dose.
• Antécédents d’événement hémorragique du système nerveux central au cours des 12 mois précédant la visite 1.
• Antécédents d’hémoptysie ou d’hématurie, d’hémorragie ou d’ulcères gastro-intestinaux actifs et/ou de lésion majeure ou d’intervention chirurgicale majeure au cours des 3 mois précédant la visite 1.
• Ratio normalisé international (INR) > 2 à la visite 1
• Temps de prothrombine (PT) et le temps partiel de thromboplastine (PTT)> 150% de la LSN institutionnelle à la visite 1.
6. Intervention chirurgicale majeure3 prévue pendant la participation à l’étude : transplantation pulmonaire, chirurgie abdominale majeure ou chirurgie intestinale majeure.
7. Antécédents d’événement thrombotique (accident vasculaire cérébral ou accident ischémique transitoire compris) au cours des 12 mois précédant la visite 1.
8. Antécédents d’insuffisance rénale de phase terminale nécessitant une dialyse.
9. Traitement par la n-acétylcystéine, la prednisone >15 mg par jour ou > 30 mg tous les 2 jours OU par une dose équivalente d’autres corticoïdes oraux et/ou par la fluvoxamine au cours des deux semaines précédant la visite 2.
10. Traitement par l’azathioprine, le cyclophosphamide, la cyclosporine ou par tout autre médicament en cours d’expérimentation au cours des huit semaines précédant la visite 2.
11. Traitement précédent par la pirfénidone.
12. Arrêt définitif du nintedanib dans le passé en raison d’EI jugés imputables au traitement.
13. Hypersensibilité connue au nintedanib, à la pirfénidone, aux arachides ou au soja ou à l’un de leurs excipients.
14. Maladie ou état qui, selon l’investigateur, est susceptible d’interférer avec les procédures de l’étude ou d’exposer le patient à un risque du fait de sa participation à l’étude.
15. Consommation excessive d’alcool ou toxicomanie qui, selon le médecin traitant, pourraient interférer avec le traitement.
16. Femmes enceintes, allaitant ou qui envisageant une grossesse pendant l’essai.
17. Femmes en âge de procréer refusant ou incapables d’utiliser une méthode contraceptive ayant fait ses preuves conformément à l’ICH M3 (R2), donnant un faible taux d’échec, inférieur à 1% par an, en étant utilisée constamment et correctement5 pendant 28 jours avant et 3 mois après l’administration du nintedanib.
18. Patients incapables de comprendre et de respecter les procédures de l’étude, y compris de répondre sans aide aux questionnaires auto-administrés.
19. Patients nécessitant une diminution de la dose et/ou une interruption temporaire pendant la période initiale avec administration du nintedanib 150 mg bid.

E.5 End points

E.5.1

Primary end point(s)

1: The primary endpoint is the percentage of patients with on-treatment gastrointestinal (GI) AEs (SOC GI disorders) from baseline to week 12

Le critère de jugement principal est le pourcentage de patients présentant des EI gastro-intestinaux sous traitement entre l’évaluation initiale et la semaine 12.

E.5.1.1

Timepoint(s) of evaluation of this end point

1: 12 weeks

12 semaines

E.5.2

Secondary end point(s)

1: Pre-dose plasma concentrations at steady state (Cpre,ss) of nintedanib at baseline, weeks
2 and 4

2: Pre-dose plasma concentrations at steady state (Cpre,ss) of pirfenidone at weeks 2 and 4.

1: Concentrations plasmatiques du nintedanib avant la dose, à l’état d’équilibre (Cpre,ss), à l’examen initial et aux semaines 2 et 4.
2: Concentrations plasmatiques de la pirfénidone avant la dose, l’état d’équilibre (Cpre,ss), aux semaines 2 et 4.

E.5.2.1

Timepoint(s) of evaluation of this end point

1: baseline, week 2 and week 4

2: week 2 and week 4

1: à l'inclusion, semaine 2 et semaine 4

2: semaine 2 et semaine 4

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

E.6.6

Pharmacokinetic

Yes

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)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Canada

France

Germany

Italy

Netherlands

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

LVLS: dernière visite du dernier patient

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:

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

F.4.2.2

In the whole clinical trial

135

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 treated according to clinical practice

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

2015-08-25

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-08-26

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2017-01-31

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Clinical trials