Clinical Trials Register

Summary
EudraCT Number:	2016-004266-25
Sponsor's Protocol Code Number:	16-OBE001-005
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:	2017-01-25
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

2016-004266-25

A.3

Full title of the trial

A phase 3, double-blind, randomized, placebo-controlled study to assess the safety and efficacy of a single oral administration of nolasiban to improve pregnancy rates following IVF or ICSI in Day 3 and Day 5 fresh embryo transfer cycles

Estudio doble ciego, aleatorizado, de fase 3, controlado con placebo para evaluar la seguridad y eficacia de una única administración por vía oral de nolasiban para mejorar las tasas de embarazo después de un tratamiento FIV o ICSI en los días 3 y 5 de ciclos de transferencia de embriones frescos.

A.3.1

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

Placebo controlled study of nolasiban to improve pregnancy rates in women undergoing IVF/ICSI

Estudio controlado con placebo de nolasiban para mejorar la tasa de embarazo en mujeres sometidas a tratamiento FIV o ICSI.

A.4.1

Sponsor's protocol code number

16-OBE001-005

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	ObsEva S.A.
B.1.3.4	Country	Switzerland
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	ObsEva S.A.
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	IVI Valencia
B.5.2	Functional name of contact point	Investigador Principal-Dr. Bosch
B.5.3	Address:
B.5.3.1	Street Address	Plaza de la Policia local, 3
B.5.3.2	Town/ city	Valencia
B.5.3.3	Post code	46015
B.5.3.4	Country	Spain
B.5.4	Telephone number	34963050900
B.5.6	E-mail	Ernesto.Bosch@ivi.es

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Nolasiban
D.3.2	Product code	OBE001 50mg
D.3.4	Pharmaceutical form	Dispersible 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	Nolasiban
D.3.9.1	CAS number	1477482-19-1
D.3.9.2	Current sponsor code	OBE001
D.3.9.3	Other descriptive name	OBE001
D.3.9.4	EV Substance Code	SUB130545
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	50
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	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	No
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	Nolasiban
D.3.2	Product code	OBE001 200mg
D.3.4	Pharmaceutical form	Dispersible 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	Nolasiban
D.3.9.1	CAS number	1477482-19-1
D.3.9.2	Current sponsor code	OBE001
D.3.9.3	Other descriptive name	OBE001
D.3.9.4	EV Substance Code	SUB130545
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	200
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Dispersible tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Dispersible tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Embryo implantation in women undergoing IVF or ICSI with Day 3 or Day 5 fresh embryo transfer cycles, in the context of Assisted Reproductive Technology (ART).

Implantación de embriones en mujeres sometidas a FIV o ICSI con ciclos de transferencia de embriones frescos del Día 3 o Día 5, en el contexto de la Tecnología de reproducción asistida (TRA).

E.1.1.1

Medical condition in easily understood language

Embryo implantation in women undergoing IVF or ICSI with fresh embryo transfer cycles, in the context of Assisted Reproductive Technology (ART).

Implantación de embriones en mujeres sometidas a FIV o ICSI con ciclos de transferencia de embriones frescos, en el contexto de la Tecnología de reproducción asistida (TRA).

E.1.1.2

Therapeutic area

Body processes [G] - Reproductive physiologi cal processes [G08]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	19.1
E.1.2	Level	LLT
E.1.2	Classification code	10073184
E.1.2	Term	Embryo transfer
E.1.2	System Organ Class	100000004865

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 is to confirm the efficacy of a single oral 900 mg dose of nolasiban to increase the ongoing clinical pregnancy rate at 10 weeks post-embryo transfer (ET) day.

El objetivo principal es confirmar la eficacia de una dosis oral única de 900 mg de nolasiban para aumentar la tasa de embarazos clínicos en curso a las 10 semanas posteriores al día de transferencia de embriones (TE).

E.2.2

Secondary objectives of the trial

The secondary objective is to assess the efficacy of a single oral 900 mg dose of nolasiban to increase the live birth rate

El objetivo secundario es evaluar la eficacia de una dosis oral única de 900 mg de nolasiban para aumentar la tasa de nacimientos con vida.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. The Subject must provide written informed consent prior to initiation of any study related procedures, as shown by a signature on the informed consent form.
2. The Subject must be aged 18 years to 36 years inclusive at screening.
3. The Subject must be indicated for IVF/ICSI in the context of assisted reproductive technology (ART).
4. The Subject must have undergone not more than one unsuccesful (negative βhCG test) COH for IVF or ICSI (whether fresh and/or several frozen ET resulted from that COH). Any attempts before a prior clinical pregnancy (observed embryo with heart beat) do not count.
5. The Subject must in the current COH cycle for IVF/ICSI follow a GnRH antagonist protocol with or without pre-treatment with an oral contraceptive pill or estradiol.
6. The Subject must in the current COH cycle for IVF/ICSI receive a single injection of hCG for triggering final follicular maturation.
7. The Subject must in the current COH cycle for IVF/ICSI receive a luteal phase support with vaginal micronized progesterone at 600 mg per day (or local alternative if not available) beginning the morning after OPU.
8. The Subject must undergo oocyte retrieval for IVF/ICSI and subsequent fresh transfer on day 3 or day 5 post-OPU day.
9. The Subject must have at least one good quality embryo in the current COH cycle.
10. The Subject is scheduled for a single fresh embryo transfer in the current COH cycle.
11. The Subject must have at least 1 functional ovary.
12. The Subject must have a BMI ≥ 18 kg/m2 and ≤ 38 kg/m2.
13. The Subject must be able to communicate well with the investigator and research staff and to comply with the requirements of the study protocol.

Para ser apto para su inclusión en este estudio, el sujeto debe cumplir todos los criterios siguientes:
1. El sujeto debe dar su consentimiento informado por escrito antes del comienzo de cualquier procedimiento del estudio, mediante la firma del Formulario de Consentimiento Informado.
2. El sujeto debe tener una edad comprendida entre los 18 y los 36 años, ambos inclusive, en la visita de screening.
3. El sujeto debe ser candidato a recibir un tratamiento de FIV o la ICSI en el contexto de la tecnología de reproducción asistida (TRA).
4. El sujeto no debe haberse sometido a más de una hiperestimulación ovárica controlada (HOC) infructuosa (análisis de beta hCG negativo) para FIV o ICSI (tanto si de dicha HOC resultaron TE frescas y/o varias TE congeladas). No se tendrá en cuenta cualquier tentativa previa a un embarazo clínico (embrión con latido cardíaco observado).
5. El sujeto debe seguir el protocolo de antagonista de GnRH en el ciclo de HOC actual para FIV/ICSI con o sin tratamiento previo con un anticonceptivo oral o estradiol.
6. El sujeto debe recibir una inyección única de gonadotropina coriónica humana (hCG) en el ciclo de HOC actual para desencadenar la maduración folicular.
7. El sujeto debe recibir una dosis de 600 mg por día de progesterona vaginal micronizada (o alternativa local, de no estar disponible), empezando la mañana siguiente de la OPU, para el refuerzo de la fase lútea en el ciclo de HOC actual para FIV/ICSI
8. El sujeto debe someterse a extracción de ovocitos para FIV/ICSI y a la posterior transferencia de embriones frescos en los días 3 o 5 posteriores al día de la OPU.
9. El sujeto debe contar como mínimo con un embrión de buena calidad en el ciclo de HOC actual.
10. El sujeto tiene programada una única transferencia de embriones frescos en el ciclo de HOC actual.
11. El sujeto debe contar como mínimo con 1 ovario funcional.
12. El sujeto debe tener un IMC ≥ 18 kg/m2 y ≤ 38 kg/m2.
13. El sujeto debe tener la capacidad de comunicarse bien con el investigador y el personal de investigación y cumplir los requisitos del protocolo del estudio.

E.4

Principal exclusion criteria

1. The Subject undergoes a frozen-thawed embryo transfer in the current COH cycle.
2. The Subject’s partner required surgical testicular sperm extraction.
3. The Subject or partner has a known abnormal karyotype or the subject has known acquired or congenital thrombophilia disease.
4. The Subject has any condition, including findings in the medical history or in the pre-trial assessments, which in the opinion of the PI constitutes a risk or a contraindication for the participation of the subject in the trial or that could interfere with the trial objectives, conduct or evaluation.
5. The Subject has any clinically significant abnormality in the results of the screening safety laboratory tests, including AST, ALT, GGT, alkaline phosphatase or total bilirubin above twice upper limit of normal. In case of isolated GGT increase, a single re-test is allowed.
6. The Subject has a serum P4 level greater than 1.5 ng/mL on the day of hCG administration.
7. The Subject had more than 20 oocytes retrieved in the current COH cycle.
8. The Subject has any significant abnormality relevant to the ART procedure and outcome, in the results of the screening gynecological examination, which in the opinion of the PI could interfere with the trial objectives, conduct or evaluation (e.g. significant uterine anomaly, hydrosalpinx or fibroid(s) documented during screening ultrasound).
9. The Subject has a known severe endometriosis (stage III or IV) and/or adenomyosis.
10. The Subject is at significant risk of severe Ovarian Hyper Stimulation Syndrome (OHSS).
11. The Subject has any clinically significant abnormality on arterial blood pressure (BP) or heart rate (HR) at screening.
12. The Subject has known positive results from virology tests for hepatitis B surface antigen (HBsAg) (not due to vaccination), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) 1 or 2. However, subjects who have resolved hepatitis B infection may be enrolled in the study.
13. The Subject is prone to frequent, severe hypersensitivity to drugs.
14. The Subject has been administered with any experimental drug in the 12 weeks before dosing.
15. The Subject is likely to require treatment with drugs that are not permitted during the study from the day after OPU up to the the Week 2 visit (OPU day + 14 days) such as:
• Drugs with utero-relaxant properties: Ca channel blockers, beta-sympathomimetic agents, nitroglycerine, magnesium sulfate (MgSO4), potassium channel openers, NSAIDs, drugs for functional GI disorders
• Drugs with utero-tonic properties: Dopamine, progesterone antagonists, prostaglandin analogues
• Triptans and ergotamines
16. The Subject has a history of, or known current (within twelve months) problems with alcohol or drug abuse.
17. The subject has a history of recurrent pregnancy loss defined as 3 or more consective pregnancy losses including biochemical pregnancies. Miscarriage prior to a live birth does not count.
18. The subject has a history of difficult transfers (e.g. tenaculum use or blood stained cathether).
19. The subject undergoes a D3 transfer after the randomization limit for D3 transfers has been reached or the subject undergoes a D5 transfer after the randomization limit for D5 transfers has been reached.

Para ser apto para su inclusión en este estudio, el sujeto no debe cumplir con ninguno de los criterios siguientes:
1. El sujeto se somete a una transferencia de embriones congelados-descongelados en el ciclo de HOC actual.
2. La pareja del sujeto necesitó una extracción quirúrgica testicular de espermatozoides.
3. El sujeto o su pareja tiene un cariotipo anormal conocido o el sujeto padece una enfermedad trombofílica adquirida o congénita conocida.
4. El sujeto tiene alguna afección, incluyendo los datos obtenidos de los antecedentes médicos o de las evaluaciones previas al estudio que, en opinión del investigador principal (IP), constituya un riesgo o una contraindicación para la participación del sujeto en el estudio o que pudiera interferir con los objetivos, el desarrollo o la evaluación del estudio.
5. El sujeto presenta alguna anomalía de importancia clínica en los resultados de las pruebas analíticas de seguridad del período de screening, incluyendo niveles de AST, ALT, GGT, fosfatasa alcalina o bilirrubina total por encima del doble del límite superior de la normalidad. En caso de incremento puntual de los niveles de GGT, se permitirá programar un nuevo análisis.
6. El sujeto tiene un nivel de P4 en suero superior a 1,5 ng/mL el día de la administración de la hCG.
7. Al sujeto se le extrajeron más de 20 ovocitos en el ciclo de HOC actual.
8. El sujeto presenta alguna anomalía relevante para el procedimiento de TRA y su desenlace; en los resultados obtenirdos durante la exploración ginecológica realizada en el screening que, en opinión del IP, pudiera interferir con los objetivos, el desarrollo o la evaluación del estudio (p. ej., malformación uterina importante, hidrosálpinx o fibroma(s) documentada(s) durante la exploración por ultrasonido).
9. El sujeto tiene endometriosis grave conocida (fase III o IV) o adenomiosis.
10. El sujeto presenta riesgo importante de padecer síndrome de hiperestimulación ovárica grave (SHO).
11. El sujeto presenta alguna alteración clínicamente significativa de la presión arterial (PA) o la frecuencia cardíaca (FC) en el período de screening.
12. El sujeto tiene un resultado positivo en las pruebas virológicas para la detección del antígeno de superficie de la hepatitis B (AgHB) (no debida a vacunación), el virus de la hepatitis C (VHC) o el virus de inmunodeficiencia humana (VIH) 1 u 2. Sin embargo, los sujetos en los que la infección por hepatitis B haya remitido podrán ser incluidos en el estudio.
13. El sujeto es propenso a hipersensibilidad grave y recurrente a medicamentos
14. A el sujeto se le ha administrado un medicamento experimental en las 12 semanas previas a la iniciación del tratamiento.
15. El sujeto puede requerir tratamiento con medicamentos cuya administración no esté permitida durante el estudio a partir del día siguiente a la OPU y hasta la visita de la Semana 2 (día de la OPU + 14 días) tales como:
a. Medicamentos con propiedades uteroinhibidoras: antagonistas del calcio, agentes betasimpaticomiméticos, nitroglicerina, sulfato de magnesio (MgSO4), activadores de los canales de potasio, antinflamatorios no esteroides (AINE), medicamentos para los trastornos digestivos funcionales:
b. Medicamentos con propiedades uterotónicas: dopamina, antagonistas del receptor de la progesterona, análogos de la prostaglandina
c. Triptanos y ergotamínicos
16. El sujeto tiene antecedentes o problemas actuales conocidos (dentro de un intervalo temporal de doce meses) de alcoholismo y drogadicción.
17. El sujeto tiene antecedentes de pérdida recurrente de embarazos definidas como 3 o más pérdidas consecutivas de embarazos, incluidos embarazos bioquímicos. No se tendrá en cuenta el aborto antes del parto.
18. El sujeto tiene antecedentes de transferencias complicadas (p. ej., uso de tenáculo o catéter manchado de sangre).
19. El sujeto se somete a una transferencia D3 después de que se haya alcanzado el límite de aleatorización para transferencias D3 o la sujeto se somete a una transferencia D5 después de que se haya alcanzado el límite de aleatorización para transferencias D5.

E.5 End points

E.5.1

Primary end point(s)

Intra-uterine pregnancy with fetal heart beat at 10 weeks post-ET day.

Embarazo intrauterino con latido cardíaco fetal a las 10 semanas posteriores al día de la TE.

E.5.1.1

Timepoint(s) of evaluation of this end point

As soon as the last subject has completed the last scheduled visit up to Week 10 visit and all data up to this visit have been entered into the clinical database, cleaned and locked, the results for the study will be analysed up to the Week 10 visit and described in a Clinical Study Report.

En cuanto el último sujeto haya completado la semana 10 y todos los datos se hayan bloqueado, se revelarán los grupos de tratamiento y se analizarán y describirán los resultados hasta la visita de la Semana 10 en el Informe de Estudio Clínico.

E.5.2

Secondary end point(s)

Live birth after 24 weeks of gestation.

Recién nacido vivo después de 24 semanas de gestación.

E.5.2.1

Timepoint(s) of evaluation of this end point

After the data from the Pregnancy Outcome and Neonatal Health forms are available and the information from the ASQ-3 has been collected.

Después de que los datos de los formularios de resultados de embarazo y salud neonatal están disponibles y se ha recopilado la información del ASQ-3.

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)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

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

Ukraine

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

For administrative and safety reporting purposes the end of the study will be defined as the date of the final clinical database lock (including the pregnancy, neonatal and infant 6-month follow-up). This provides a single and conservative definition across all study sites.

Para fines administrativos y de notificación de seguridad, el final del estudio se definirá como la fecha del cierre de la base de datos clínicos (incluyendo el embarazo, el recién nacido y el seguimiento del recién nacido a los 6 meses). Esto proporciona una definición única y conservadora en todos los centros del estudio.

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

760

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

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

Yes

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

127

F.4.2

For a multinational trial

F.4.2.1

In the EEA

660

F.4.2.2

In the whole clinical trial

760

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

2017-03-21

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-03-09

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2019-02-19

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IMP with orphan designation in the indication
Orphan Designation Number:
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