Clinical Trials Register

Summary
EudraCT Number:	2017-001559-30
Sponsor's Protocol Code Number:	SMKV-013-CP4
National Competent Authority:	France - ANSM
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2017-08-31
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

France - ANSM

A.2

EudraCT number

2017-001559-30

A.3

Full title of the trial

Efficacy of long-term parenteral nutrition with SmofKabiven® E concomitant to chemo- and/or immunotherapy: A prospective, randomised, controlled, open, multicentre, two-stage, adaptive clinical trial in metastatic non-small cell lung cancer

Efficacité de la nutrition parentérale à long terme avec le SmofKabiven® E en complément d’une chimiothérapie et/ou une immunothérapie : essai clinique prospectif, randomisé, contrôlé, ouvert, multicentrique, en deux étapes, adaptatif, dans le cancer du poumon non à petites cellules métastatique

A.3.1

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

Effects of SmofKabiven® E, a nutrition solution given into the vein, in lung cancer patients

Effet du SmofKabiven® E, solution nutrition donnée dans la veine, chez les patients atteints d'un cancer du poumon

A.3.2

Name or abbreviated title of the trial where available

SmofKabiven® E long-term Parenteral Nutrition in Oncology

A.4.1

Sponsor's protocol code number

SMKV-013-CP4

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	Fresenius Kabi Deutschland GmbH
B.1.3.4	Country	Germany
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	Fresenius Kabi Deutschland GmbH
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Fresenius Kabi Deutschland GmbH
B.5.2	Functional name of contact point	Divisional Medical Clinical Affairs
B.5.3	Address:
B.5.3.1	Street Address	Else-Kröner-Straße 1
B.5.3.2	Town/ city	Bad Homburg
B.5.3.3	Post code	61352
B.5.3.4	Country	Germany
B.5.4	Telephone number	+496172 668 4598

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	SmofKabiven E
D.2.1.1.2	Name of the Marketing Authorisation holder	Fresenius Kabi France
D.2.1.2	Country which granted the Marketing Authorisation	France
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Emulsion for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Parenteral use (Noncurrent)
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	parenteral nutrition solution for infusion containing glucose, lipids and amino acids with electrolytes
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	Soluvit
D.2.1.1.2	Name of the Marketing Authorisation holder	Fresenius Kabi France
D.2.1.2	Country which granted the Marketing Authorisation	France
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Lyophilisate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Parenteral use (Noncurrent)
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	Vitamins for infusion
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	Vitalipid Adult
D.2.1.1.2	Name of the Marketing Authorisation holder	Fresenius Kabi France
D.2.1.2	Country which granted the Marketing Authorisation	France
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Emulsion for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Parenteral use (Noncurrent)
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	vitamin emulsion for injection
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.2.1.1.1	Trade name	Suppliven
D.2.1.1.2	Name of the Marketing Authorisation holder	Fresenius Kabi France
D.2.1.2	Country which granted the Marketing Authorisation	France
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Solution for injection/infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Parenteral use (Noncurrent)
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	trace mineral solution for infusion

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

Metastatic Non-Small Cell Lung Cancer

Cancer du poumon non à petites cellules métastatique

E.1.1.1

Medical condition in easily understood language

Lung cancer

Cancer du poumon

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	10059515
E.1.2	Term	Non-small cell lung cancer metastatic
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 show superiority in efficacy indicated by change in total body weight, of long-term PN with SmofKabiven E in addition to oral nutrition according to standard of care (test group) over oral nutrition as per standard of care alone (control group) during chemo- and/or immunotherapy.

Le principal objectif de cette étude est de montrer la supériorité de l’efficacité caractérisée par un changement du poids corporel total, de la nutrition parentérale à long terme avec le SmofKabiven® E en complément de la nutrition orale conforme aux recommandations de nutrition (groupe test) par rapport à la nutrition orale
conforme aux recommandations de nutrition seule (groupe contrôle), pendant une chimio-et/ou immunothérapie.

E.2.2

Secondary objectives of the trial

The secondary objectives of the study are to compare the 2 treatment groups with regard to nutritional efficacy, chemo- and/or immunotherapy compliance and side effects, functional outcome, body composition, quality of life, therapy response and survival.

Les objectifs secondaires de l’étude sont de comparer les deux groupes en ce qui concerne l’efficacité nutritionnelle, l’observance et les effets secondaires de la chimiothérapie et/ou immunothérapie, le résultat fonctionnel, la composition corporelle, la qualité de vie, la réponse thérapeutique et la survie.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Metastatic NSCLC patient
2. Adult ≥ 18 years
3. Starting any 1st, 2nd or 3rd line chemotherapy and/or immunotherapy administered via a central venous catheter (including implanted ports)
4. Moderate malnutrition defined by ≥ 5 % weight loss in the last month or ≥ 10% in the last 6 months
5. An energy gap of ≥ 40 % between the target energy intake (30 ± 5 kcal/kg/day) and the actual energy intake at screening
6. Functional digestive tract allowing oral intake
7. Signed informed consent from patient or legal representative

1. Patient atteints d’un cancer du poumon non à petites cellules métastatique
2. Patient adulte âgé d’au moins 18 ans
3. Débutant une chimiothérapie et/ou une immunothérapie de 1ère, 2e ou 3e ligne administrée via un cathéter veineux central (y compris ports implantés)
4. Malnutrition modérée, définie par une perte de poids ≥ 5 % au cours du dernier mois ou ≥ 10 % au cours des six derniers mois
5. Écart énergétique ≥ 40 % entre les apports énergétiques cibles (30 ± 5 kcal/kg/jour) et les apports énergétiques réels au moment du recrutement
6. Tractus digestif fonctionnel permettant une alimentation orale
7. Consentement éclairé signé par le patient ou son représentant légal

E.4

Principal exclusion criteria

1. PN administered during the preceding month (the sole administration of intravenous glucose is allowed)
2. More than 1600 kcal/day required as PN
3. Tube feeding at screening
4. Severe malnutrition defined by ≥ 10 % weight loss in the last month or ≥ 15 % weight loss in the last 6 months
5. Body mass index (BMI) > 30 kg/m2
6. Performance status > 3 Eastern Cooperative Oncology Group (ECOG) score
7. Life expectancy < 3 months
8. Active bloodstream infection demonstrated by positive blood culture at screening
9. Hypersensitivity to fish-, egg, soya- or peanut protein or to any of the active substances or excipients in SmofKabiven E
10. Severe blood coagulation disorders
11. Congenital errors of amino acid metabolism
12. Pathologically elevated serum levels of any of the included electrolytes
13. General contraindications to infusion therapy: acute pulmonary oedema, hyperhydration, decompensated cardiac insufficiency
14. Hemophagocytotic syndrome
15. Severe hyperlipidemia (serum triglycerides > 353 mg/dL)
16. Severe liver insufficiency: liver enzymes (aspartate aminotransferase [AST], alanine aminotransferase [ALT], gamma glutamyl transferase [GGT]) or conjugated bilirubin exceeding 3 x upper limit of normal range, or International Normalised Ratio (INR) > 2
17. Severe renal dysfunction (estimated glomerular filtration rate [eGFR] < 30 ml/min/1.73m2) and patients on renal replacement therapy
18. Uncontrolled hyperglycaemia
19. Unstable conditions (e.g., embolism, metabolic acidosis, hypotonic dehydration)
20. Pregnancy or lactation
21. Contraindications to any of the study assessment methods including computer tomography and indirect calorimetry
22. Participation in a clinical study with an investigational drug or investigational medical device within one month prior to start of study or during study
23. Prior inclusion in the present study

1. Nutrition parentérale administrée au cours du mois précédent (uniquement l’administration par voie intraveineuse de glucose est autorisée)
2. Plus de 1600 kcal/jour nécessaires par nutrition parentérale
3. Alimentation par sonde au moment du recrutement
4. Malnutrition sévère, définie par une perte de poids ≥ 10 % au cours du dernier mois ou ≥ 15 % au cours des six derniers mois
5. Indice de masse corporelle (IMC) > 30 kg/m2
6. Statut de performances ECOG (Eastern Cooperative Oncology Group) > 3
7. Espérance de vie < 3 mois
8. Infection active du sang démontrée par une hémoculture positive au moment du recrutement
9. Hypersensibilité aux protéines de poisson, d’œuf, de soja ou d’arachide ou à l’un des ingrédients actifs ou des excipients du SmofKabiven E
10. Troubles graves de la coagulation sanguine
11. Troubles congénitaux du métabolisme des acides aminés
12. Concentrations sériques pathologiquement élevées de l’un des électrolytes contenus dans la solution
13. Contre-indications générales à un traitement par perfusion : œdème pulmonaire aigu, hyperhydratation, insuffisance cardiaque décompensée
14. Syndrome hémophagocytaire
15. Hyperlipidémie sévère (triglycérides sériques > 353 mg/dl)
16. Insuffisance hépatique sévère : Enzymes hépatiques (aspartate aminotransférase [AST], alanine aminotransférase [ALT], gamma-glutamyl transférase [GGT]) ou bilirubine conjuguée dépassant 3 x la limite supérieure de la normale ou rapport international normalisé (INR, International Normalised Ratio) > 2
17. Insuffisance rénale sévère (taux de filtration glomérulaire estimé [eGFR] < 30 ml/min/1,73 m2) et patients sous dialyse
18. Hyperglycémie non contrôlée
19. États cliniques instables (par ex. embolie, acidose métabolique, déshydratation hypotonique)
20. Grossesse ou allaitement
21. Contre-indications à l’une des méthodes d’évaluation de l’étude, notamment tomodensitométrie et calorimétrie indirecte
22. Participation à une étude clinique portant sur un médicament ou un dispositif médical expérimental au cours du mois précédant le début de l’étude ou pendant l’étude
23. Inclusion antérieure dans la présente étude

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint is the change in total body weight (kg) at the end of treatment after 9 ± 1 weeks of study treatment compared to baseline.

Le critère d’évaluation principal est la modification du poids corporel total (kg) en fin de traitement, après 9 ± 1 semaines de traitement à l'étude, comparé à sa valeur initiale.

E.5.1.1

Timepoint(s) of evaluation of this end point

Measure at Baseline Visit, Interim visits and Final Visit at 9 +/- 1 weeks after Baseline Visit

Mesure à la visite initiale, aux visites intermédiaires et à la visite final à 9 +/- 1 semaine après la visite initiale

E.5.2

Secondary end point(s)

Nutritional status
Body composition
Functional Outcome (Karnofsky, ECOG performance status, Handgrip strength)
Chemotherapy compliance
Chemotherapy side effects and Fatigue determined based on records in the BFI questionnaire.
Other endpoints: 3 months, 6 months overall survival and progression-free survival, Partial and complete response rates (as per RECIST v 1.1), Unplanned Hospitalization, Quality of Life (Functional Assessment of Cancer Therapy-General (FACT-G) score)

Status nutritionnel
Composition corporelle
Résultat fonctionnel (Statuts de performances de Karnofsky et ECOG, force de préhension)
Observance de la chimiothérapie et/ou de l’immunothérapie
Effets indésirables de la chimiothérapie et/ou de l’immunothérapie et fatigue déterminée par le questionnaire BFI
Autres critères: Survie globale et survie sans progression après 3 et 6 mois, taux de réponse partielle et complète (conformément aux critères RECIST v. 1.1), hospitalisation non planifiée, qualité de vie (score FACT-G)

E.5.2.1

Timepoint(s) of evaluation of this end point

Nutritional status: measured at Baseline, Interim and final visits
Body composition: measured at Baseline and final visits
Functional Outcome: measured at Baseline, Interim and final visits
Chemotherapy compliance: measured at Baseline, Interim, final and Follow-up 1 visits
Chemotherapy side effects and BFI questionnaire: measured at Baseline, Interim and final visits
Other endpoints:
• 3 months, 6 months overall survival and progression-free survival, Partial and complete response rates (as per RECIST v 1.1), Unplanned Hospitalization measured at final and follow-up visits
• Quality of Life (Functional Assessment of Cancer Therapy-General (FACT-G) score) at baseline and follow-up visits

Status nutritionnel: visites initiale, intermédiaires et finale
Composition corporelle: visites initiale et finale
Résultat fonctionnel: visites initiale, intermédiaires et finale
Observance de la chimiothérapie et/ou de l’immunothérapie: visites initiale, intermédiaires, finale et de suivi n°1
Effets indésirables de la chimiothérapie et/ou de l’immunothérapie et fatigue déterminée par le questionnaire BFI: visites initiale, intermédiaires et finale
Autres critères:
- Survie globale et survie sans progression après 3 et 6 mois, taux de réponse partielle et complète (conformément aux critères RECIST v. 1.1), hospitalisation non planifiée: visites finale et de suivi
- qualité de vie (score FACT-G): visite initiale et de suivi

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

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)

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

Yes

E.8.1.7.1

Other trial design description

multicentre, two-stage, adaptive clinical trial

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

Oral nutrition as per standard of care

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

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

End of the trial is defined as the last visit of the last patient.

La fin d'étude est définie comme étant la 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

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

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

162

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)

None

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

2017-08-30

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-09-13

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2019-04-05

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