Clinical Trials Register

Summary
EudraCT Number:	2018-002910-11
Sponsor's Protocol Code Number:	18-OBE001-010
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:	2018-11-23
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2018-002910-11

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 increase ongoing pregnancy rate following fresh single blastocyst transfer resulting from IVF

Estudio doble ciego, aleatorizado, de fase 3, controlado con placebo para evaluar la seguridad y eficacia de una única administración por vía oral de nolasibán para aumentar la tasa de embarazo en curso, después de una única transferencia de blastocito fresco obtenido mediante un tratamiento de FIV.

A.3.1

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

Placebo-controlled study to assess nolasiban to increase pregnancy rates in women undergoing IVF

Estudio controlado con placebo para evaluar nolasiban para aumentar la tasa de embarazo en mujeres en tratamiento de FIV

A.3.2

Name or abbreviated title of the trial where available

IMPLANT 4

A.4.1

Sponsor's protocol code number

18-OBE001-010

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 SA
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 SA
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 Bilbao
B.5.2	Functional name of contact point	Investig. Principal – Dr. Ferrando
B.5.3	Address:
B.5.3.1	Street Address	Paseo Landabarri Bidea 1
B.5.3.2	Town/ city	Leioa (Bizkaia)
B.5.3.3	Post code	48940
B.5.3.4	Country	Spain
B.5.4	Telephone number	+34944 80 60 20
B.5.5	Fax number	+34944 80 60 29
B.5.6	E-mail	Marcos.Ferrando@ivirma.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	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	NOLASIBAN (OBE001)
D.3.9.4	EV Substance Code	SUB130545
D.3.10	Strength
D.3.10.1	Concentration unit	mg/g milligram(s)/gram
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	NOLASIBAN (OBE001)
D.3.9.4	EV Substance Code	SUB130545
D.3.10	Strength
D.3.10.1	Concentration unit	mg/g milligram(s)/gram
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.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 with Day 5 fresh embryo transfer cycles

Implantación embrionaria en mujeres sometidas a FIV en el Día 5 del ciclo de transferencia de embriones frescos.

E.1.1.1

Medical condition in easily understood language

Embryo implantation in women undergoing IVF with Day 5 fresh embryo transfer cycles

Implantación embrionaria en mujeres sometidas a FIV en el Día 5 del ciclo de transferencia de embriones frescos.

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	20.0
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 versus placebo 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 Nolasibán comparado con placebo 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 versus placebo to increase the live birth rate.

El objetivo secundario es evaluar la eficacia de una dosis oral única de 900 mg de Nolasibán comparado con placebo para aumentar la tasa de nacidos vivos.

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 37 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 (no good quality embryos produced or negative βhCG test) controlled ovarian hyperstimulation (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. If the subject had one unsuccessful COH cycle, as described in inclusion criteria 4 above, they must have obtained at least one good quality embryo for transfer.
6. 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.
7. The subject must in the current COH cycle for IVF/ICSI receive a single injection of hCG for triggering final follicular maturation.
8. 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 beginning the morning after OPU.
9. The subject must undergo oocyte retrieval for IVF/ICSI and subsequent fresh transfer on day 5 post-OPU day.
10. The subject must have at least one good quality embryo in the current COH cycle.
11. The subject is scheduled for a single fresh embryo transfer in the current COH cycle.
12. The subject must have at least 1 functional ovary.
13. The subject must have a BMI ≥ 18 kg/m2 and ≤ 38 kg/m2.
14. The subject must be able to communicate well with the investigator and research staff and to comply with the requirements of the study protocol.
15. The subject must agree to participate in the infant follow-up if she becomes pregnant.

1.El sujeto debe proveer un consentimiento informado por escrito antes del comienzo de cualquier procedimiento relacionado con el estudio, según demuestra la firma del Formulario de Consentimiento Informado.
2.El sujeto debe tener una edad comprendida entre los 18 y los 37 años, ambos inclusive, en la visita de selección.
3.Se aconsejará al sujeto el tratamiento de FIV o la IICE 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 (ausencia de producción de embriones de buena calidad o análisis de beta GCH negativo) para FIV o IICE (tanto si dicha HOC dio lugar a la transferencia de embriones frescos y/o de varios congelados). No se tendrá en cuenta cualquier tentativa previa a un embarazo clínico (embrión con latido cardíaco observado).
5.Si el sujeto tuvo un ciclo de HOC fallido, como se describe en el criterio de inclusión 4 anterior, debe haber obtenido al menos un embrión de buena calidad para la transferencia.
6.El sujeto debe seguir el protocolo de antagonista de GnRH en el ciclo de HOC actual para FIV/IICE con o sin tratamiento previo con un anticonceptivo oral o estradiol.
7.El sujeto debe recibir una inyección única de GCH en el ciclo de HOC actual para desencadenar la maduración folicular.
8.El sujeto debe recibir el apoyo de la fase lútea en el ciclo de HOC actual para FIV/IICE con progesterona vaginal micronizada en dosis de 600 mg por día a partir de la mañana siguiente a la OPU.
9.El sujeto debe someterse a extracción de ovocitos para FIV/IICE y a la posterior transferencia en fresco en el día 5, posterior al día de la OPU.
10.El sujeto debe contar como mínimo con un embrión de buena calidad en el ciclo de HOC actual.
11.El sujeto tiene programada una única transferencia de embriones frescos en el ciclo de HOC actual.
12.El sujeto debe contar como mínimo con 1 ovario funcional.
13.El sujeto debe tener un IMC ≥ 18 kg/m2 y ≤ 38 kg/m2.
14.El sujeto debe poder comunicarse bien con el examinador y el personal de investigación y cumplir los requisitos del protocolo del estudio.
15.El sujeto debe estar de acuerdo en participar en el control de seguimiento del bebé si queda embarazada.

E.4

Principal exclusion criteria

1. The subject undergoes a frozen-thawed embryo transfer in the current transfer.
2. The subject undergoes ET of an embryo from a donor egg in the current transfer.
3. The subject’s partner required surgical testicular sperm extraction in that cycle.
4. Use of assisted hatching and/or use of adherence compounds (e.g. EmbryoGlue®) for the embryo
to be transferred in the study.
5. The subject or partner has a known abnormal karyotype or the subject has known acquired or congenital thrombophilia disease.
6. Any preimplantation genetic testing of the transferred embryo.
7. The subject has any condition, including findings in the medical history or in the pre-trial assessments, which in the opinion of the investigator 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.
8. 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.
9. The subject has a serum P4 level greater than 1.54 ng/mL prior to hCG administration.
10. The subject had more than 20 oocytes retrieved in the current Controlled Ovarian Hyperstimulation (COH) cycle.
11. Subject is known to have i) impaired ovarian reserve or ii) biomarker predictor of poor response e.g. FSH, AMH, AFC.
12. The subject has any significant abnormality relevant to the ART procedure and outcome, in the
results of a gynecological examination within 6 months of screening, which in the opinion of the investigator could interfere with the trial objectives, conduct or evaluation (e.g. significant
uterine anomaly, communicating hydrosalpinx or fibroid(s) documented during ultrasound).
13. The subject has diagnosed severe endometriosis (stage III or IV) and/or adenomyosis.
14. The subject is at significant risk of severe ovarian hyper stimulation syndrome (OHSS).
15. The subject has any history of uncontrolled hypertension and/or heart disease.
16. 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.
17. The subject is prone to frequent, severe hypersensitivity to drugs.
18. The subject has been administered any experimental drug in the 12 weeks before dosing.
19. The subject is likely to require treatment with drugs that are not permitted during the study from day 4 after OPU up to the Week 2 visit (OPU day + 14 days) such as:
Drugs with utero-relaxant properties: calcium channel blockers, beta-sympathomimetic agents,
nitroglycerine, parenteral magnesium sulfate (MgSO4), potassium channel openers, NSAIDs.
20. The subject has autoimmune disease (e.g. lupus, rheumatoid arthritis) that is being medically treated.
21. The subject has a history of, or known current (within twelve months) problems with alcohol or drug abuse.
22. The subject has a history of recurrent pregnancy loss defined as 3 or more consecutive pregnancy losses including biochemical pregnancies. Miscarriage prior to a subsequent live birth does not count.
23. The subject has a history of difficult transfers (e.g. tenaculum use or blood stained catheter).

1. El sujeto se somete a una transferencia de embriones congelados-descongelados en la transferencia actual.
2.El sujeto se somete a la TE de un embrión de un óvulo donado en la transferencia actual.
3.La pareja del sujeto necesitó una extracción testicular quirúrgica de espermatozoides en ese ciclo.
4.Uso de incubación asistida y/o uso de compuestos de adherencia (p.ej. EmbryoGlue®) para el embrión que ha de transferirse en el estudio.
5.El sujeto o su pareja tiene un cariotipo anormal conocido o el sujeto padece una enfermedad trombofílica adquirida o congénita conocida.
6.Cualquier prueba genética previa a la FIV del embrión transferido.
7.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, 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.
8.El sujeto presenta alguna anomalía de importancia clínica en los resultados de las pruebas analíticas de seguridad del período de selección, incluyendo niveles de Aspartato aminotransferasa (AST), Alanina aminotransferasa (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 único nuevo análisis.
9.El sujeto tiene un nivel de P4 en suero superior a 1,54 ng/ml antes de la administración de la gonadotrofina coriónica humana (GCH).
10.Al sujeto se le extrajeron más de 20 ovocitos en el ciclo de hiperestimulación ovárica controlada (HOC) actual.
11.Se sabe que el sujeto tiene i) reserva ovárica dañada o ii) biomarcador predictor de respuesta deficiente, p. ej. FSH, AMH, AFC.
12.El sujeto presenta alguna anomalía importante relevante para el procedimiento de TRA y su desenlace en los resultados de la exploración ginecológica dentro de los 6 meses a la selección que, en opinión del investigador, 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).
13.El sujeto tiene endometriosis grave conocida (estadio III o IV) y/o adenomiosis.
14.El sujeto presenta riesgo importante de padecer síndrome de hiperestimulación ovárica grave (SHO).
15.El sujeto tiene antecedentes de hipertensión no controlada y/o enfermedad cardíaca.
16.El sujeto tiene resultados positivos conocidos en las pruebas virológicas para la detección del antígeno de superficie de la hepatitis B (HBsAg) (no debida a vacunación), el virus de la hepatitis C (VHC) o el virus de inmunodeficiencia humana (VIH) 1 u 2. Sin embargo, las pacientes en las que la infección por hepatitis B haya remitido podrán ser incluidas en el estudio.
17. El sujeto es propenso a hipersensibilidad grave y recurrente a medicamentos.
18.El sujeto se le ha administrado un medicamento experimental en las 12 semanas previas a la iniciación del tratamiento.
19.El sujeto puede requerir tratamiento con medicamentos cuya administración no esté permitida durante el estudio a partir del día 4 después de la OPU hasta la visita de la semana 2 (día de la OPU + 14 días) tales como:
Fármacos con propiedades uterorrelajantes: antagonistas del calcio, agentes betasimpaticomiméticos, nitroglicerina, sulfato de magnesio (MgSO4) por vía parenteral, activadores de los canales de potasio, antinflamatorios no esteroides (AINEs).
20.El sujeto tiene una enfermedad autoinmune (por ejemplo, lupus, artritis reumatoide) que está siendo tratado médicamente.
21.El sujeto tiene antecedentes o problemas actuales conocidos (dentro de un intervalo temporal de doce meses) de alcoholismo y drogadicción.
22.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 espontáneo anterior a un parto.
23.El sujeto tiene antecedentes de transferencias complicadas (p. ej., uso de tenáculo o catéter manchado de sangre).

E.5 End points

E.5.1

Primary end point(s)

Ongoing pregnancy defined as an intra-uterine pregnancy with fetal heart beat at 10 weeks post-ET day.

Embarazo en curso, definido como 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 week 10 and all data have been locked, the treatment groups will be unblinded, and the results up to the Week 10 visit will be analysed and described in a Clinical Study Report.

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

E.5.2

Secondary end point(s)

Live birth after 24 weeks of gestation.

Nacidos vivos 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, newborn, and neonatal health at 28 days are available and the information from the ASQ-3 questionnaires (at 6 months after birth corrected for gestational age at birth.) has been collected.

Después que los datos sobre el parto, el recién nacido y la salud del bebé a los 28 días estén disponibles, y que la información del Cuestionario ASQ-3 (a los 6 meses de nacimiento, corregido de acuerdo con la edad gestacional) haya sido recogida.

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

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

Belgium

Canada

Czech Republic

Denmark

Estonia

Finland

Germany

Hungary

Poland

Russian Federation

Spain

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

The date of the final clinical database lock (including the pregnancy, neonatal and infant 6-month follow-up).

La fecha del cierre de la base de datos (incluyendo el embarazo y el seguimiento del recién nacido y a los 6 meses).

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:

820

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

F.4.2

For a multinational trial

F.4.2.1

In the EEA

729

F.4.2.2

In the whole clinical trial

820

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

2018-11-19

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-10-25

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

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials