Clinical Trials Register

Summary
EudraCT Number:	2016-005008-24
Sponsor's Protocol Code Number:	GEM-KyCyDex
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2017-10-02
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

Spain - AEMPS

A.2

EudraCT number

2016-005008-24

A.3

Full title of the trial

Carfilzomib and Dexamethasone in combination with Cyclophosphamide vs. Carfilzomib and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma: a phase II randomized controlled trial.

Carfilzomib y Dexametasona en combinación con Ciclofosfamida vs. Carfilzomib y Dexametasona en Pacientes con Mieloma Múltiple en Recaída/Refractario: un ensayo clínico de fase II aleatorizado y controlado.

A.3.1

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

Carfilzomib and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma

Carfilzomib y Dexametasona en Pacientes con Mieloma Múltiple en Recaída/Refractario

A.4.1

Sponsor's protocol code number

GEM-KyCyDex

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	FUNDACIÓN PETHEMA
B.1.3.4	Country	Spain
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	AMGEN
B.4.2	Country	Spain
B.4.1	Name of organisation providing support	BAXTER
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	FUNDACIÓN PETHEMA
B.5.2	Functional name of contact point	Juan José Lahuerta Palacios
B.5.3	Address:
B.5.3.1	Street Address	Profesor Martín Lagos s/n
B.5.3.2	Town/ city	Madrid
B.5.3.3	Post code	28040
B.5.3.4	Country	Spain
B.5.4	Telephone number	+34913303311
B.5.6	E-mail	jjlahuerta@telefonica.net

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	Kyprolis
D.2.1.1.2	Name of the Marketing Authorisation holder	Amgen Europe B.V.
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	Powder 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	CARFILZOMIB
D.3.9.1	CAS number	868540-17-4
D.3.9.2	Current sponsor code	CARFILZOMIB
D.3.9.3	Other descriptive name	CARFILZOMIB
D.3.9.4	EV Substance Code	SUB32911
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	60
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	Genoxal
D.2.1.1.2	Name of the Marketing Authorisation holder	Baxter Oncology GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	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	CICLOFOSFAMIDA
D.3.9.1	CAS number	6055-19-2
D.3.9.2	Current sponsor code	CICLOFOSFAMIDA
D.3.9.3	Other descriptive name	CYCLOPHOSPHAMIDE MONOHYDRATE
D.3.9.4	EV Substance Code	SUB16414MIG
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	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	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.2.1.2	Country which granted the Marketing Authorisation	Spain
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	Dexametasona
D.3.2	Product code	Dexametasona
D.3.4	Pharmaceutical form	Tablet
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	DEXAMETHASONE
D.3.9.2	Current sponsor code	DEXAMETHASONE
D.3.9.3	Other descriptive name	DEXAMETHASONE
D.3.9.4	EV Substance Code	SUB07017MIG
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	4
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

Relapsed/Refractory Multiple Myeloma

Mieloma Múltiple en recaída o refractario

E.1.1.1

Medical condition in easily understood language

Multiple Myeloma

Mieloma Múltiple

E.1.1.2

Therapeutic area

Diseases [C] - Blood and lymphatic diseases [C15]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10028228
E.1.2	Term	Multiple myeloma
E.1.2	System Organ Class	100000054086

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate the efficacy of carfilzomib and dexamethasone in combination with cyclophosphamide in terms of progression free survival (PFS) in relapsed/refractory (R/R) multiple myeloma (MM) patients.

Evaluar la eficacia de carfilzomib y dexametasona en combinación con ciclofosfamida en términos de supervivencia libre de progresión (SLP) en pacientes con mieloma múltiple (MM) en Recaída/Refractario (R/R).

E.2.2

Secondary objectives of the trial

To evaluate the efficacy in terms of:
- Overall response rate (ORR): stringent complete response (sCR) + complete remission (CR) + very good partial response (VGPR) + partial response (PR).
- Achievement of immunophenotypic CR
- Time to progression (TTP)
- Overall survival (OS).
To evaluate the safety determined by the incidence of clinical and analytical toxicities.
To evaluate the influence of subclones and biomarkers on the sensitivity and resistance to carfilzomib in combination with dexamethasone either with or without cyclophosphamide.

Evaluar la eficacia en términos de
- tasa de respuesta global (TRG): respuesta completa estricta (RCs) + respuesta completa (RC) + muy buena respuesta parcial (MBRP) + respuesta parcial (RP).
- consecución de RC inmunofenotípica.
- tiempo hasta progresión (TTP).
- supervivencia global (SG).
Evaluar la seguridad determinada según la incidencia de toxicidades clínicas y analíticas.
Evaluar la influencia de la presencia de subclones y biomarcadores en la sensibilidad y resistencia a carfilzomib combinado con dexametasona, tanto en presencia como en ausencia de ciclofosfamida.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Age ≥ 18 years
2. Performance status (ECOG) < 2.
3. Patient is, in the investigator’s opinion, willing and able to comply with the protocol requirements.
4. Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
5. Patients previously diagnosed with MM according to the IMWG criteria (Lancet Oncology 2014) that after previous treatment with 1-3 regimens require therapy due to a relapse/progression of the disease.
6. Patients must have measurable disease, defined as follows:
• Serum monoclonal protein value ≥ 0,5 g/L, or
• Urine light-chain excretion of ≥ 0,2 g/24 hours, or
• Abnormal serum free light chains (FLCs) plus involved FLC level ≥ 100 mg/L

1. Edad ≥ 18 años.
2. Estado general (ECOG) < 2.
3. El paciente, en la opinión del investigador, está capacitado y dispuesto a cumplir con los requerimientos del protocolo.
4. El paciente ha otorgado voluntariamente su consentimiento informado antes de que se lleve a cabo cualquiera de los procedimientos relacionados con el estudio que no sea parte de la atención médica normal, entendiendo que dicho consentimiento puede ser revocado por el paciente en cualquier momento sin perjuicio de su futura atención médica.
5. Los pacientes diagnosticados previamente de MM de acuerdo con los criterios del IMWG (Lancet Oncology 2014) que tras haber recibido de 1 a 3 líneas de tratamiento previamente requieran tratamiento nuevamente debido a la recaída o progresión de la enfermedad.
6. Los pacientes deben tener enfermedad cuantificable, definida como sigue:
• Proteína monoclonal en suero ≥ 0,5 g/L, o
• Excreción urinaria de cadenas ligeras ≥ 0,2 g/24 horas, o
• Ratio Cadenas Ligeras Libres en suero (CLLs) alterada más un nivel de Cadenas Ligeras Libres (CLL) afecta ≥ 100 mg/L.

E.4

Principal exclusion criteria

1. Primary refractory patients defined as not having achieved at least a PR with a prior therapy.
2. Refractoriness to prior proteasome inhibitor therapies, defined as not having achieved at least MR or having progressed under treatment or in the first 60 days after the last dose of the proteasome inhibitor.
3. Non adequate haematological or biochemical parameters as specified below:
• Hemoglobin <8.0 g/dL.
• Platelets count <75x109/L without previous platelet transfusions in the last 7 days. If high bone marrow infiltration (>50%) is present, ≥50x109/L platelet count is required.
• Absolute neutrophil count (ANC) <0.75 x109/L without previous G-CSF support in the last 7 days.
• Aspartate transaminase (AST): >2.5 x the upper limit range.
• Alanine transaminase (ALT): >2.5 x the upper limit range.
• Total bilirubin: >2 x the upper limit range.
• Calculated or measured creatinine clearance: <30 mL/min (calculated from the Cockcroft and Gault formula)
4. Left ventricular ejection fraction <50%.
5. Absence of recovery from any significant non-haematological toxicity derived from previous treatments. The presence of alopecia and NCI-CTC grade < 2 symptomatic peripheral neuropathy is allowed.
6. Pregnant or lactating women; men and women of reproductive potential who are not using effective contraceptive methods (double barrier method, intrauterine device, oral contraception).
7. Previous history of any other neoplastic disease in the last five years (except basal cell carcinoma, skin epithelioma or carcinoma in situ of any site).
8. Other relevant diseases or adverse clinical conditions:
• Congestive heart failure or angina pectoris, myocardial infarction within 12 months before inclusion in the study.
• Uncontrolled arterial hypertension or cardiac arrhythmias (i.e. requiring a change in medication within the last 3 months or a hospital admission within the past 6 months).
• History of significant neurological or psychiatric disorders.
• Active infection.
• Significant non-neoplastic liver disease (e.g., cirrhosis, active chronic hepatitis).
9. Patient is known to be human immunodeficiency virus (HIV) positive, hepatitis B surface antigen-positive or to suffer active hepatitis C infection.
10. Concomitant anti-myeloma therapy within 14 days prior to Day 1 of Cycle 1.
11. Limitation of the patient’s ability to comply with the treatment or follow-up protocol.
12. Uncontrolled endocrine diseases (e.g. diabetes mellitus, hypothyroidism or hyperthyroidism) (i.e. requiring relevant changes in medication within the last month, or hospital admission within the last 3 months).

1. Pacientes refractarios primarios definidos como los que no han alcanzado al menos una RP con tratamiento previo.
2. Refractariedad a tratamientos previos con inhibidores del proteosoma, definida como no haber conseguido al menos una respuesta menor (RM), o haber progresado durante el tratamiento o durante los primeros 60 días tras la última dosis de inhibidor del proteosoma.
3. Presencia de una o más alteraciones bioquímicas o hematológicas según se especifica a continuación:
• Hemoglobina < 8,0 g/dL.
• Recuento de plaquetas < 75x109/L sin infusión previa de plaquetas en los últimos 7 días. Si el porcentaje de infiltración de la médula ósea es superior al 50%, el recuento de plaquetas requerido es ≥ 50x109/L.
• Recuento absoluto de neutrófilos (RAN) < 0,75 x109/L sin haber recibido soporte con G-CSF en los últimos 7 días.
• Aspartato transaminasa (AST): > 2,5 veces el límite superior normal.
• Alanina transaminasa (ALT): > 2,5 veces el límite superior normal.
• Aclaramiento de creatinina medido o calculado: < 30 mL/min (calculado mediante la fórmula de Cockcroft y Gault)
4. Fracción de eyección del ventrículo izquierdo < 50%.
5. Ausencia de recuperación de cualquier toxicidad no hematológica derivada de un tratamiento previo. La presencia de alopecia y de neuropatía sintomática de grado NCI-CTCAE (National Cancer Institute- Common Terminology Criteria for Adverse Events) < 2 no serán motivo de exclusión.
6. Mujeres embarazadas o en periodo de lactancia; hombres y mujeres con potencial reproductor que no estén utilizando medidas anticonceptivas eficaces (método de barrera doble, dispositivo intrauterino, anticonceptivos orales).
7. Historia previa de cualquier otra neoplasia durante los últimos cinco años (excepto carcinoma de células basales, epitelioma de la piel o carcinoma in situ en cualquier localización).
8. Otras enfermedades relevantes o condiciones clínicas adversas:
• Insuficiencia cardiaca congestiva, angina de pecho o infarto de miocardio durante los 12 meses anteriores a la inclusión en el estudio.
• Hipertensión arterial no controlada o arritmias cardiacas (que hubieran requerido un cambio de medicación durante los últimos 3 meses u hospitalización durante los últimos 6 meses).
• Historial de trastornos neurológicos o psiquiátricos significativos.
• Infección activa
• Enfermedad hepática no neoplásica significativa (p.ej., cirrosis, hepatitis crónica activa).
9. El paciente es positivo para el virus de la inmunodeficiencia humana (VIH), o para el antígeno de superficie de la hepatitis B o sufre hepatitis C activa.
10. El paciente ha recibido otros tratamientos frente al mieloma dentro de los 14 días previos al primer día del ciclo 1.
11. El paciente presenta limitaciones en su habilidad para cumplir con el tratamiento o el protocolo de seguimiento.
12. Enfermedades endocrinas (p.ej., diabetes mellitus, hipotiroidismo o hipertiroidismo) fuera de control (que han requerido cambios relevantes en la medicación durante el último mes u hospitalización durante los últimos 3 meses).

E.5 End points

E.5.1

Primary end point(s)

Progression Free Survival (PFS) to carfilzomib + dexamethasone + cyclophosphamide

Supervivencia Libre de Progresion (SLP) con carfilzomib + dexametasona + ciclofosfamida.

E.5.1.1

Timepoint(s) of evaluation of this end point

Progression Free Survival (PFS) is defined as the number of months from randomization to the earlier of disease progression or death due to any cause. Disease outcome determined will be the primary data source for the final PFS analysis. The primary analysis of PFS (and other efficacy endpoints unless specified otherwise) will include all randomized patients that received at least one dose of study treatment

La Supervivencia Libre de Progresión (SLP) se define como el número de meses desde la aleatorización hasta la progresión de la enfermedad o el fallecimiento por cualquier causa, lo primero que ocurra. El desenlace de la enfermedad será la fuente de datos primaria para el análisis final de SLP. El análisis primario de SLP (y de las demás variables de eficacia en estudio, a menos que se especifique lo contrario) incluirá a todos los pacientes aleatorizados que hayan recibido al menos una dosis del tratamiento en estudio.

E.5.2

Secondary end point(s)

- Overall Rate Response (ORR), rate of inmmunophenotypic Complete Response (CRi), TIme to Progression (TTP) and Overall Survival (OS).
- The grade and frequency of clinical and laboratory toxicities (AE/SAEs), and treatment discontinuations.
- Evaluation of the influence of the subclonal heterogenicity and biomarkers on the sensittivity/resistance of carfilzomib.

- Tasa de Respuesta Global (TRG), tasa de Respuesta Completa (RC) inmunofenotípica, Tiempo hasta Progresión (TTP) y Supervivencia Global (SG).
- Grado y frecuencia de toxicidades clínicas y analíticas (AA/AAGs), e interrupciones del tratamiento.
- Evaluación de la influencia de la heterogeneidad subclonal y los biomarcadores en la sensibilidad/resistencia al carfilzomib.

E.5.2.1

Timepoint(s) of evaluation of this end point

The analysis of the secondary efficacy endpoints Overall Rate Response, TIme to Progression and Overall Survival will be based on all randomized patients that received at least one dose of study treatment

El análisis de las variables secundarias en estudio Tasa de Respuesta Global, Tiempo hasta Progresión y Supervivencia Global se basará en todos los pacientes aleatorizados que hayan recibido al menos una dosis del tratamiento en estudio.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

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

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Carfilzomib+Dexametasona

Carfilzomib+Dexametasone

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

LVLS

UVUP

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:

200

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

270

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

Ninguno

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

2017-11-13

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-10-23

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

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