Clinical Trials Register

Summary
EudraCT Number:	2014-000184-40
Sponsor's Protocol Code Number:	20130173
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2014-09-01
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

Spain - AEMPS

A.2

EudraCT number

2014-000184-40

A.3

Full title of the trial

Prospective, Multicenter, Single-arm Study to Evaluate Efficacy, Safety, and
Pharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta

Estudio prospectivo, multicéntrico y de un solo brazo para evaluar la eficacia, seguridad y farmacocinética de denosumab en niños con osteogénesis imperfecta

A.3.1

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

Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta

Estudio para evaluar la eficacia, seguridad y farmacocinética de denosumab en niños con osteogénesis imperfecta

A.4.1

Sponsor's protocol code number

20130173

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/086/2013

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Amgen, Inc.
B.1.3.4	Country	United States
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	Amgen Inc
B.4.2	Country	United Kingdom
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Amgen (Europe) GmbH
B.5.2	Functional name of contact point	IHQ-Medical Info - Clinical Trials
B.5.3	Address:
B.5.3.1	Street Address	Dammstrasse 23, P.O Box 1557
B.5.3.2	Town/ city	Zug
B.5.3.3	Post code	CH-6300
B.5.3.4	Country	Switzerland
B.5.4	Telephone number	900850153
B.5.6	E-mail	MedinfoInternational@amgen.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	XGEVA
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	European Union
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	Denosumab
D.3.2	Product code	AMG 162
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Denosumab
D.3.9.1	CAS number	615258-40-7
D.3.9.2	Current sponsor code	AMG 162
D.3.9.3	Other descriptive name	Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
D.3.9.4	EV Substance Code	SUB29173
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	70
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.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

Osteogenesis Imperfecta

Osteogénesis imperfecta

E.1.1.1

Medical condition in easily understood language

Osteogenesis Imperfecta

Osteogénesis imperfecta

E.1.1.2

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	17.0
E.1.2	Level	PT
E.1.2	Classification code	10031243
E.1.2	Term	Osteogenesis imperfecta
E.1.2	System Organ Class	10010331 - Congenital, familial and genetic 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

To evaluate the effect of denosumab on lumbar spine bone mineral density (BMD) Z-score at 12 months, as assessed by dual-energy X-ray absorptiometry (DXA), in children 2 to 17 years of age with osteogenesis imperfecta (OI).

Evaluar el efecto de denosumab en la puntuación Z de la densidad mineral ósea (DMO) de la columna lumbar a los 12 meses, evaluada mediante absorciometría por rayos
X de energía dual (DXA), en niños de 2 a 17 años de edad con osteogénesis imperfecta (OI).

E.2.2

Secondary objectives of the trial

To evaluate denosumab in children 2 to 17 years of age with OI with
respect to:
- Change in lumbar spine BMD Z-score, as assessed by DXA, at 6, 18, 24, and 36 months
- Change in proximal femur BMD Z-score, as assessed by DXA, at 6, 12, 18, 24, and 36 months
- Incidence of new and worsening fractures (x-ray confirmed long bone and vertebral fractures) from pre-treatment to post-treatment at 12, 24, and 36 months
- Incidence of improving vertebral fractures from pre-treatment to post-treatment at 12, 24, and 36 months (overall, among subjects with clinical fracture reduction, and among subjects with clinical fracture increase)
- Incidence of pre-treatment compared with post-treatment vertebral and nonvertebral fractures at 12, 24, and 36 months
+ Exploratory and Safety objectives
For complete list, please refer to the protocol

-Cambio en la puntuación Z de la DMO de la columna lumbar, evaluada mediante DXA, a
los 6, 18, 24 y 36 meses.
-Cambio en la puntuación Z de la DMO del fémur proximal, evaluada mediante DXA, a los
6, 12, 18, 24 y 36 meses.
-Incidencia de fracturas nuevas y empeoradas (fracturas de huesos largos y vertebrales
confirmadas mediante radiografías) desde antes del tratamiento hasta los 12, 24 y 36
meses después del tratamiento.
-Incidencia de la mejora de las fracturas vertebrales desde antes del tratamiento hasta los
12, 24 y 36 meses después del tratamiento (global, entre los sujetos con reducción de
las fracturas clínicas y entre los sujetos con aumento de las fracturas clínicas).
-Incidencia de fracturas vertebrales y no vertebrales antes del tratamiento en
comparación con después del tratamiento a los 12, 24 y 36 meses.
Para el resto de objetivos secundarios ver protocolo.?

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

PK/bone turnover markers (BTM) substudy of approximately 50 subjects to
- determine serum concentration of denosumab at 1 and 10 days and 6, 12, 18, 24, 30, and 36 months in all subjects
- evaluate changes observed in bone turnover markers (bone-specific alkaline phosphatase [BSAP], serum type I collagen C-telopeptide [sCTX])

PK/marcadores de remodelado óseo [BTM] con aproximadamente 50 sujetos para determinar la concentración sérica de denosumab al cabo de 1 y 10 días y a los 6, 12, 18, 24, 30 y 36 meses en todos los sujetos.
Evaluar cambio en los marcadores de remodelado óseo (fosfatasa alcalina específica del hueso [BSAP], C-telopéptido del colágeno tipo 1 sérico [sCTX]).

E.3

Principal inclusion criteria

-Informed consent (to be provided by parent or legal guardian) and informed assent (to be provided by subjects when age-appropriate).
-Children aged 2 to 17 years inclusive at screening
-Clinical diagnosis of OI defined as a clinical history consistent with type I-IV OI as determined by presence of expected phenotype (examples include: facial shape, voice, blue sclera, dentinogenesis imperfecta, typical radiographic features, fracture pattern) and lack of additional features unrelated to type I-IV OI (eg, blindness, mental retardation, neuropathy, craniosynostosis; premature exfoliation of deciduous teeth)
?* If familial, also must be autosomal dominant
- Clinical severity of OI as defined by
o 2 or more prevalent vertebral compression fractures; OR
o 1 prevalent vertebral compression fracture and 1 or more nonvertebral fractures within the previous 2 years; OR
o 3 or more fractures within the previous 2 years

.El representante legal autorizado del sujeto ha dado su consentimiento informado cuando el sujeto es legalmente demasiado joven para dar su
consentimiento informado y el sujeto ha dado su conformidad por escrito de acuerdo con las normativas y/o directrices locales antes de iniciar cualquier
actividad/procedimiento específico del estudio.
.Niños de 2 a 17 años de edad, ambos incluidos, en el momento de la selección.
.Diagnóstico clínico de OI, definido como una historia clínica que coincide con la de OI de tipo I-IV, determinada por la presencia del fenotipo esperado (ejemplos: forma facial, voz, esclerótica azul, dentinogénesis imperfecta, características
radiográficas típicas, patrón de fractura) y la falta de características adicionales
no relacionadas con la OI de tipo I-IV (p. ej., ceguera, retraso mental, neuropatía,craneosinostosis; exfoliación prematura de los dientes de leche de aspecto
normal).
? -Si es familiar, también debe ser autosómica dominante.
.La gravedad clínica de la OI se define como
- 2 o más fracturas por compresión vertebral prevalentes;
- 1 fractura por compresión vertebral prevalente y 1 o más fracturas no vertebrales en los 2 años previos; O
- 3 o más fracturas en los 2 años previos.

E.4

Principal exclusion criteria

Subjects meeting any of the following criteria at screening are not eligible for enrollment:
- Inability or unwillingness to comply with the requirements for frequent calcium and phosphorus monitoring for 14 days after the first dose of denosumab (only applies to the first 5 subjects age 11 to17 enrolled in the study and the first 5 subjects of any age meeting the criteria for increased bone turnover (see Section 2.3.2.1)
- Currently unhealed fracture or osteotomy as defined by orthopedic opinion
- Osteotomy within 5 months of screening
- Evidence of untreated oral cavities or oral infections
- Recent or planned invasive dental procedure
- Surgical tooth extraction which has not healed by screening
- History of an electrophoresis pattern inconsistent with type I to IV OI
- History of genetic testing results inconsistent with type I to IV OI
- Abnormalities of the following per central laboratory reference ranges at screening:
o Serum albumin corrected calcium < lower limit of normal (LLN)
o Serum vitamin D < 30 ng/mL; re-screening for Vitamin D level
< 30 ng/mL will be allowed, after adequate supplementation
o Aspartate aminotransferase (AST), alanine aminotransferase (ALT)
> 1.5 x upper limit of normal (ULN)
o Total bilirubin (TBL) > 1.5 x ULN (subjects with Gilbert syndrome are
eligible)
o Serum phosphorus < LLN
o Serum alkaline phosphatase > 20% above the ULN or > 20% below the
LLN
- Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2 (calculated by the Schwartz equation at screening)
- Evidence of any of the following:
o Current hyperthyroidism (unless well-controlled on stable antithyroid
therapy)
o Current clinical hypothyroidism (unless well-controlled on stable thyroid replacement therapy)
o History of hyperparathyroidism
o Current hypoparathyroidism
o Current, uncontrolled hypercalcemia (albumin-corrected serum Ca >10% ULN)
o Current metaphyseal index Z-score > +1
o History of osteomalacia or rickets (chart review)
o Other bone diseases that affect bone metabolism (eg, osteoporosis
pseudoglioma syndrome, idiopathic juvenile osteoporosis, osteopetrosis, hypophosphatasia)
o History of autoimmune disease
o History of malabsorption (in children with serum albumin < LLN,
malabsorption should be clinically ruled out by the PI to confirm eligibility)
o History of rare hereditary problems of fructose intolerance
o History of long QT syndrome
o History of non-healing osteotomy
o History of malignancy
o History of alcohol or drug abuse
o History of any solid organ or bone marrow transplant
o Contraindicated or poorly tolerant of denosumab therapy
- Positive blood screen for human immunodeficiency virus -1 or -2
antibody
- Positive blood screen for hepatitis B surface antigen or hepatitis C antibody
- Currently pregnant or planning a pregnancy during the study and for an additional 5 months after the last dose of denosumab
- For sexually active girls: refusal to use acceptable methods of contraception and to continue this practice for 5 months after the last injection of denosumab

-Incapacidad o falta de voluntad de cumplir los requisitos de supervisión frecuente del calcio y el fósforo durante 14 días tras la primera dosis de denosumab (solo se aplica a los primeros 5 sujetos de entre 11 y 17 años incluidos en el estudio y a los primeros 5 sujetos de cualquier edad que cumplan los criterios de aumento del remodelado óseo (consulte el apartado 2.3.2.1).
-Presencia actual de fractura u osteotomía no consolidadas según criterio ortopédico.
-Osteotomía en los 5 meses anteriores a la selección.
-Evidencia de cavidades orales o infecciones orales no tratadas.
-Procedimiento dental invasivo reciente o planeado.
-Extracción dental quirúrgica que no se ha curado en el momento de la selección.
-Antecedentes de un patrón de electroforesis incompatible con la OI de tipo I a IV.
-Antecedentes de resultados de pruebas genéticas incompatibles con la OI de tipo I a IV.
-Calcio corregido por albúmina sérica < límite inferior de la normalidad (LIN).
-Vitamina D sérica < 30 ng/mL; se podrá volver a realizar la reselección por nivel de vitamina D < 30 ng/mL después de la suplementación adecuada.
-Aspartato aminotransferasa (AST) o alanina aminotransferasa (ALT) > 1,5 x el límite superior de la normalidad (LSN).
-Bilirrubina total (BiT) > 1,5 x LSN (los sujetos con síndrome de Gilbert son elegibles).
-Fósforo sérico < LIN.
-Fosfatasa alcalina sérica > 20% por encima del LSN o > 20% por debajo del LIN.
-Tasa de filtración glomerular estimada (eGFR) < 60 mL/min/1,73 m2 (calculada con la ecuación de Schwartz en el momento de la selección).
Evidencia de cualquiera de las siguientes situaciones:
-Hipertiroidismo actual (a no ser que esté bien controlado con tratamiento antitiroideo estable).
-Hipotiroidismo clínico actual (a no ser que esté bien controlado con tratamiento de sustitución tiroidea estable).
-Antecedentes de hiperparatiroidismo.
-Hipoparatiroidismo actual.
-Hipercalcemia incontrolada actual (Ca sérico corregido por albúmina > 10% del LSN).
-Puntuación Z del índice metafisario actual > + 1.
-Antecedentes de osteomalacia o raquitismo (revisión de la historia clínica).
-Otras enfermedades óseas que afectan al metabolismo óseo (por ejemplo, síndrome de osteoporosis-pseudoglioma, osteoporosis juvenil idiopática, osteopetrosis e hipofosfatasia) (revisión de la historia clínica).
-Antecedentes de enfermedad autoinmune.
-Antecedentes de malabsorción (en niños con albúmina sérica < LIN; la malabsorción debe ser descartada clínicamente por el investigador para confirmar la elegibilidad).
-Antecedentes de problemas hereditarios raros de intolerancia a la fructosa
-Antecedentes de síndrome de QT largo.
-Antecedentes de osteotomía no consolidada.
-Antecedentes de neoplasias malignas.
-Antecedentes de alcoholismo o drogadicción.
-Antecedentes de trasplantes de órganos sólidos o de médula ósea.
-Contraindicaciones o mala tolerancia al tratamiento con denosumab.
-Análisis de sangre positivo para anticuerpos frente al virus de la inmunodeficiencia humana de tipo 1 o 2
-Análisis de sangre positive para anticuerpos frente al antigen de superficie de la hepatitis B o frente a la hepatitis C.
-Embarazo actual o planificación de embarazo durante el estudio y durante los 5 meses adicionales después de la última dosis de denosumab.
-Lactancia actual o planificación de dar el pecho durante el estudio y durante los 5 meses adicionales después de la última dosis de denosumab.
-En el caso de las chicas sexualmente activas: rechazo a utilizar métodos anticonceptivos aceptables y a seguir utilizándolos durante los 5 meses posteriores a la última inyección de denosumab.

E.5 End points

E.5.1

Primary end point(s)

Change from baseline in lumbar spine BMD Z-score, as assessed by DXA, at 12 months.

Cambio respecto al valor basal en la puntuación Z de la DMO de la columna
lumbar, evaluada mediante DXA, a los 12 meses.

E.5.1.1

Timepoint(s) of evaluation of this end point

at 12 months

A los 12 meses

E.5.2

Secondary end point(s)

- Change from baseline in lumbar spine BMD Z-score, as assessed by DXA, at 6, 18, 24, and 36 months
- Change from baseline in proximal femur BMD Z-score, as assessed by DXA, at 6, 12, 18, 24, and 36 months
- Subject incidence of new and worsening fractures (x-ray confirmed long bone and vertebral fractures) at 12, 24, and 36 months compared to pre-treatment
- Subject incidence of improved vertebral fractures at 12, 24, and 36 months compared to pre-treatment
- Subject incidence of vertebral and nonvertebral fractures at 12, 24, and 36 months compared to pre-treatment
- Change from baseline in CHQ-PF-50 Physical Summary score at 12, 24, and 36 months
- Change from baseline in CHQ-PF-50 Psychological Summary score at 12, 24, and 36 months
- Change from baseline in CHAQ Disability Index score at 12, 24, and 36 months
- Change from baseline in WBFPRS at 12, 24, and 36 months
- Change from baseline in growth velocity (determined by calculating age-adjusted Z-scores for height, weight and BMI) at 36 months
- Serum concentration of denosumab at 1 and 10 days, and 6, 12, 18, 24, 30, and 36 months
- Serum concentration of denosumab at 1, 10, and 30 days, and 3, 6, 12, 18, 24, 30, and 36 months (PK/BTM substudy only)

-Cambio respecto al valor basal en la puntuación Z de la DMO de la columna lumbar,
evaluada mediante DXA, a los 6, 18, 24 y 36 meses.
-Cambio respecto al valor basal en la puntuación Z de la DMO del fémur proximal,
evaluada mediante DXA, a los 6, 12, 18, 24 y 36 meses.
-Incidencia en los sujetos de fracturas nuevas y empeoradas (fracturas de huesos largos y vertebrales confirmadas mediante radiografías) a los 12, 24 y 36 meses en comparación con antes del tratamiento.
-Incidencia en los sujetos de la mejora de las fracturas vertebrales a los 12, 24 y 36
meses en comparación con antes del tratamiento.
-Incidencia en los sujetos de fracturas vertebrales y no vertebrales a los 12, 24 y 36 meses en comparación con antes del tratamiento.
-Cambio respecto al valor basal en la puntuación del resumen físico del cuestionario CHQ-PF-50 a los 12, 24 y 36 meses.
-Cambio respecto al valor basal en la puntuación del resumen psicológico del cuestionario CHQ-PF-50 a los 12, 24 y 36 meses.
-Cambio respecto al valor basal en la puntuación del índice de discapacidad CHAQ a los 12, 24 y 36 meses.
-Cambio respecto al valor basal en la escala WBFPRS a los 12, 24 y 36 meses.
-Cambio respecto al valor basal en la velocidad de crecimiento (determinada mediante el
cálculo de las puntuaciones Z ajustadas por edad para la altura, el peso y el índice de
masa corporal [IMC]) a los 36 meses.
-Concentración sérica de denosumab al cabo de 1 y 10 días, y a los 6, 12, 18, 24, 30 y 36
meses.
-Concentración sérica de denosumab al cabo de 1, 10 y 30 días, y a los 3, 6, 12, 18, 24, 30 y 36 meses (solo en el subestudio de PK/BTM).

E.5.2.1

Timepoint(s) of evaluation of this end point

see list above

Ver la lista de arriba punto E 5.2

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

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)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

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

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

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

Australia

Bulgaria

Canada

Czech Republic

Finland

France

Germany

Hungary

Poland

Spain

United Kingdom

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 the trial is defined when all enrolled subjects are given the
opportunity to be followed for approximately 3 years for the purposes of final collection of data for the final analysis. ( LPLV)

El fin del ensayo se define como el momento en que se ofrece a todos
los sujetos incluidos la oportunidad de someterse a seguimiento durante
aproximadamente 3 años con la finalidad de recoger los datos para el análisis final.

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

Yes

F.1.1

Number of subjects for this age range:

150

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)

Yes

F.1.1.5.1

Number of subjects for this age range:

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

F.1.2

Adults (18-64 years)

F.1.3

Elderly (>=65 years)

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

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

150

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

2014-10-19

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-10-15

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2022-03-26

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