Clinical Trials Register

Summary
EudraCT Number:	2016-000744-34
Sponsor's Protocol Code Number:	204939
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:	2019-06-11
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

2016-000744-34

A.3

Full title of the trial

A phase III, randomized, observer-blind, placebo controlled, multicenter clinical trial to assess Herpes Zoster recurrence and the reactogenicity, safety and immunogenicity of GSK Biologicals’ Herpes Zoster vaccine (HZ/su) when administered intra-muscularly on a 0 and 2 month schedule to adults ≥ 50 years of age with a prior episode of Herpes Zoster

Ensayo clínico de fase III, multicéntrico, aleatorizado, observador ciego y controlado con placebo para evaluar la recurrencia de herpes zóster y la reactogenicidad, seguridad e inmunogenicidad de la vacuna frente al herpes zóster (HZ/su) de GSK Biologicals cuando se administra por vía intramuscular en una pauta de 0 y 2 meses a adultos de 50 años o más con un episodio previo de herpes zóster

A.3.1

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

A study to evaluate the safety and immunogenicity of GlaxoSmithKline’s Shingrix vaccine when given on a two-dose schedule to adults at least 50 years of age (YOA) who had prior episode of shingles

Estudio para evaluar la seguridad y la inmunogenicidad de la vacuna Shingrix de GlaxoSmithKline cuando se administra con una pauta de dos dosis a adultos de al menos 50 años de edad con un episodio previo de herpes zóster

A.3.2

Name or abbreviated title of the trial where available

ZOSTER-062

A.4.1

Sponsor's protocol code number

204939

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	GlaxoSmithKline S.A.
B.1.3.4	Country	Spain
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	GlaxoSmithKline Biologicals
B.4.2	Country	Belgium
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	GlaxoSmithKline S.A.
B.5.2	Functional name of contact point	CENTRO DE INFORMACIÓN
B.5.3	Address:
B.5.3.1	Street Address	c/ Severo Ochoa, 2
B.5.3.2	Town/ city	Tres Cantos (Madrid)
B.5.3.3	Post code	28760
B.5.3.4	Country	Spain
B.5.4	Telephone number	34902202700
B.5.5	Fax number	34918070479
B.5.6	E-mail	es-ci@gsk.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	SHINGRIX
D.2.1.1.2	Name of the Marketing Authorisation holder	GlaxoSmithKline Biologicals SA
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	Herpes Zoster subunit vaccine (GSK1437173A)
D.3.2	Product code	HZ/su
D.3.4	Pharmaceutical form	Powder and suspension for suspension for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Varicella Zoster Virus Glycoprotein E antigen
D.3.9.2	Current sponsor code	gE Antigen
D.3.9.3	Other descriptive name	RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E
D.3.9.4	EV Substance Code	SUB31416
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(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	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)	Yes
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Powder and solution for solution for injection
D.8.4	Route of administration of the placebo	Intramuscular use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Healthy volunteers (Prevention of Herpes Zoster)

Voluntarios sanos (prevención del Herpes Zoster)

E.1.1.1

Medical condition in easily understood language

Shingles

Culebrillas

E.1.1.2

Therapeutic area

Diseases [C] - Virus Diseases [C02]

MedDRA Classification

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 compare the incidence of HZ recurrence in the HZ/su group to the placebo group
A formal non-inferiority analysis will be performed.
Criterion: The objective is met if the upper limit (UL) of the 95% CI of the ratio of the incidence of HZ recurrence (HZ/su versus placebo) is below 5.

Comparar la incidencia de recurrencia del HZ en el grupo HZ/su con la del grupo placebo
Se realizará un análisis formal de no inferioridad
Criterio: El objetivo se cumple si el límite superior (LS) del IC del 95% del cociente de la incidencia de recurrencia del HZ (HZ/su frente a placebo) es inferior a 5.

E.2.2

Secondary objectives of the trial

•To evaluate the rate of HZ recurrence in HZ/su and placebo groups during the entire study period.
•To evaluate safety and reactogenicity following administration of HZ/su vaccine or placebo within 30 days after each dose.
•To evaluate safety following administration of HZ/su vaccine or placebo during the entire study period.
•To characterize anti-gE humoral immunogenicity response prior to the first vaccination (Day 1), at two months post first vaccination (Month 2) and at one month post last vaccination (Month 3) in both groups.

•Evaluar la tasa de recurrencia del HZ en los grupos HZ/su y placebo durante el período completo del estudio.
• Evaluar la seguridad y la reactogenicidad tras la administración de la vacuna HZ/su o de placebo en los 30 días siguientes a cada dosis.
• Evaluar la seguridad tras la administración de la vacuna HZ/su o placebo durante el período completo del estudio.
• Definir la inmunogenicidad de la respuesta humoral anti-gE antes de la primera vacunación (día 1), dos meses después de la primera vacunación (mes 2) y un mes después de la última vacunación (mes 3) en ambos grupos.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

•Subjects and/or subject’s LAR(s) who, in the opinion of the investigator, can and will comply with the requirements of the protocol
•Written informed consent obtained from the subject/subject’s LAR(s) prior to performance of any study specific procedure.
•A male or female ≥ 50 YOA at the time of the first vaccination.
•Subjects with a history of HZ. Confirmation of the prior HZ diagnosis can be done by one of the following three methods:
Clinically diagnosed HZ OR Laboratory diagnosed HZ OR HZ diagnosed by an adjudication committee
Female subjects of non-childbearing potential may be enrolled in the study.
(Non-childbearing potential is defined as current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy, bilateral salpingectomy or post-menopause).
•Female subjects of childbearing potential may be enrolled in the study if the subject:
has practiced adequate contraception for 30 days prior to vaccination, and
has a negative pregnancy test on the day of vaccination, and
has agreed to continue adequate contraception for 2 months after completion of the vaccination series.

• Sujeto y/o representante legal que, en opinión del investigador, pueda y vaya a cumplir los requisitos del protocolo.
• Obtención del consentimiento informado por escrito del sujeto o su representante legal antes de realizar ningún procedimiento específico del estudio.
• Varón o mujer de 50 años o más en el momento de la primera vacunación.
• Sujeto con antecedentes de HZ. La confirmación del diagnóstico previo de HZ podrá hacerse mediante uno de los tres métodos siguientes:
− HZ diagnosticado clínicamente O HZ diagnosticado por un laboratorio O HZ diagnosticado por un comité de adjudicación
• En el estudio podrán participar mujeres sin capacidad reproductiva.
La incapacidad reproductiva se define como la presencia de ligadura u oclusión de ambas trompas, histerectomía, ovariectomía bilateral, salpingectomía bilateral o posmenopausia
• En el estudio podrán participar mujeres en edad fértil si:
− Han utilizado métodos anticonceptivos adecuados desde 30 días antes de la vacunación y tienen una prueba de embarazo negativa el día de la vacunación y
han aceptado seguir utilizando un método anticonceptivo adecuado durante 2 meses después de finalizar la serie de vacunación.

E.4

Principal exclusion criteria

•Subjects who at time of study entry or during the maximum period of anticipated study participation are/will become part of the population recommended to receive a zoster vaccine per existing local or national immunization practices will be excluded from study participation.
•Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the first dose of study vaccine, or planned use during the study period.
•Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
•Onset of HZ in the past 6 months or any ongoing symptoms from a prior HZ episode.
•Chronic antiviral use for HZ prophylaxis.
•History of >1 prior episode of HZ.
•A history of disseminated HZ, cutaneous or associated with visceral disease or associated with neurologic disease caused by VZV infection.
•Use or anticipated use of immunosuppressants or immune-modifying drugs during the period starting six months prior to study start and during the whole study period. This includes chronic administration of corticosteroids, long-acting immune-modifying agents or immunosuppressive/cytotoxic therapy
•Administration or planned administration of a vaccine not foreseen by the study protocol within the period starting 30 days before the first dose of study vaccine and ending 30 days after the last dose of study vaccine. However, licensed pneumococcal vaccines and non-replicating vaccines may be administered up until 8 days prior to dose 1 and/or dose 2 and/or at least 14 days after any dose of study vaccine.
•Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product
•Previous vaccination against VZV or HZ.
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
•History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
•Acute disease and/or fever at the time of enrolment.
•Administration of immunoglobulins and/or any blood products during the period starting 3 months before the first dose of study vaccine or planned administration during the study period.
•Pregnant or lactating female.
•Female planning to become pregnant or planning to discontinue contraceptive precautions in the period up to 2 months after completion of the vaccination series.

• Se excluirá de participar en el estudio a los sujetos que, en el momento de incorporarse al estudio o durante el período máximo previsto de participación en el estudio, formen o pasen a formar parte de la población recomendada para recibir una vacuna frente al herpes zóster según las prácticas locales o nacionales vigentes de vacunación.
• Uso de cualquier producto (fármaco o vacuna) en investigación o no autorizado distinto de la vacuna del estudio en los 30 días previos a la primera dosis de la vacuna del estudio o uso previsto durante el período del estudio.
• Cualquier afección que, en opinión del investigador, haría insegura la inyección intramuscular.
• Comienzo del HZ en los últimos 6 meses o cualquier síntoma persistente de un episodio previo de HZ.
• Uso crónico de antivirales para la profilaxis del HZ.
• Antecedentes de más de un episodio previo de HZ.
• Antecedentes de HZ diseminado, cutáneo o asociado a enfermedad visceral o enfermedad neurológica causada por la infección por el VVZ.
• Uso confirmado o previsto de inmunosupresores o inmunomoduladores durante los seis meses previos al comienzo del estudio y durante la totalidad del período del estudio. Ello incluye la administración crónica de corticosteroides, inmunomoduladores de acción prolongada o tratamiento inmunosupresor/citotóxico
• Administración confirmada o prevista de una vacuna no prevista por el protocolo del estudio en el período comprendido entre 30 días antes de la primera dosis de la vacuna del estudio y hasta 30 días después de la última dosis de la vacuna del estudio. Sin embargo, podrán administrarse vacunas antineumocócicas y vacunas sin capacidad de replicación autorizadas hasta 8 días antes de la dosis 1 y/o dosis 2 y/o al menos 14 días después de cualquier dosis de la vacuna del estudio.
• Participación simultánea en otro estudio clínico, en cualquier momento del período del estudio, en que el sujeto haya estado expuesto o vaya a estarlo a un producto (producto farmacéutico o dispositivo) /vacuna en investigación o no en investigación.
• Vacunación previa frente al VVZ o HZ.
• Cualquier enfermedad causante de inmunosupresión o inmunodeficiencia confirmada o supuesta, basándose en los antecedentes médicos y la exploración física
• Antecedentes de cualquier reacción alérgica o de hipersensibilidad que es probable que pueda verse agravada por alguno de los componentes de la vacuna.
• Enfermedad aguda y/o fiebre en el momento del reclutamiento.
• Administración de inmunoglobulinas y/o de cualquier hemoderivado en los tres meses previos a la primera dosis de la vacuna del estudio o administración prevista durante el período del estudio.
• Mujer embarazada o en período de lactancia.
• Mujer que tenga previsto quedarse embarazada o que tengan previsto interrumpir el uso de los métodos anticonceptivos en el período comprendido hasta dos meses después de finalizar la serie de vacunación.

E.5 End points

E.5.1

Primary end point(s)

Number of confirmed Herpes Zoster (HZ) cases.
A suspected case of HZ is defined as a new unilateral rash accompanied by pain and no alternative diagnosis. A suspected case of HZ is confirmed by 2 ways:
• By PCR (Polymerase Chain Reaction)
• By the HZ Ascertainment Committee (HZAC)
The incidence of HZ recurrence in the HZ/su group versus placebo group is compared by performing a non-inferiority analysis

Número de episodios de Herpes Zoster (HZ) confirmados.
Un caso sospechoso de Herpes Zoster se define como un caso de exantema unilateral nuevo acompañado de dolor sin que exista un diagnóstico alternativo.
Los casos de sospecha de HZ podrán ser confirmados de dos maneras:
− Mediante PCR (Polymerase Chain Reaction)
− Por parte del Comité de verificación de HZ (CVHZ).
La incidencia de recurrencia del HZ en el grupo HZ/su con la del grupo placebo se compara llevanod acabo un análisis de no inferioridad

E.5.1.1

Timepoint(s) of evaluation of this end point

From one-month post-dose 2 to study end (Month 26)

Desde un mes posterior a la dosis 2 hasta el final del estudio (mes 26)

E.5.2

Secondary end point(s)

Number of confirmed HZ cases
Number of subjects with any solicited local adverse events (AEs)
Number of subjects with any solicited general adverse events (AEs)
Number of subjects with any unsolicited adverse events (AEs)
Number of subjects with any serious adverse events (SAES)
Number of subjects with any serious adverse events (SAES)
Number of subjects with any related serious adverse events (SAES)
Number of subjects with any potential immune-mediated diseases (pIMDs)
Number of subjects with any potential immune-mediated diseases pIMDs
Vaccine response rate (VRR) for anti-glycoprotein E (Anti-gE) antibodies as determined by Enzyme Linked Immuno-sorbent Assay (ELISA)
Anti-gE antibody concentrations in terms of Geometric Mean Concentrations (GMCs) as determined by ELISA

Número de episodios de HZ confirmados
Número de sujetos que notifiquen Acontecimientos Adversos (AA) locales solicitados
Número de sujetos que notifiquen Acontecimientos Adversos (AA) generales solicitados
Número de sujetos que notifiquen Acontecimientos Adversos (AA) no solicitados
Número de sujetos que notifiquen Acontecimientos Adversos Graves (AAG)
Número de sujetos que notifiquen Acontecimientos Adversos Graves (AAG)
Número de sujetos que notifiquen Acontecimientos Adversos Graves (AAG) relacionados
Número de sujetos que notifiquen enfermedades potencialmente mediadas por el sistema inmune (pEMSI)
Número de sujetos que notifiquen enfermedades potencialmente mediadas por el sistema inmune (pEMSI)
Respuesta vacunal para anticuerpos anti-gE determinados mediante ELISA
Concentraciones de anticuerpos anti-gE, en terminos de (GMCs) determinados mediante ELISA

E.5.2.1

Timepoint(s) of evaluation of this end point

From Visit Day 1 till study end (Month 26)
Within 7 days (Days 1-7) after each vaccination
Within 7 days (Days 1-7) after each vaccination
Within 30 days (Days 1-30) after each vaccination
From Visit Day 1 up to 30 days post last vaccination
From 30 days post last vaccination to 1 year post last vaccination.
During the entire study period (Visit day 1 to Month 26)
From Visit Day 1 up to 30 days post last vaccination
From 30 days post last vaccination to 1 year post last vaccination
At Month 2 and Month 3
At Day 1, Month 2 and Month 3

Desde la vista del día 1 hasta final del estudio (mes 26)
En los 7 días (días 1-7) siguientes a cada vacunación.
En los 7 días (días 1-7) siguientes a cada vacunación.
En los 30 días (días 1-30) siguientes a cada vacunación.
Desde la visita del día 1 hasta 30 día posteriores a la últia vacunación.
Desde 30 días posteriores a la última vacunación hasta un año posterior a la última vacunación.
Durante todo el periodo dle estudio (Visita día 1 hasta el mes 26),
Desde 30 días posteriores a la última vacunación hasta un año posterior a la última vacunación.
En el mes 2 y mes 3.
En el día 1, mes 2 y mes 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

E.6.4

Safety

Yes

E.6.5

Efficacy

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

Yes

E.6.13.1

Other scope of the trial description

Immunogenicity

Inmunogenicidad

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

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Observador ciego

Observer-blind

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

Hong Kong

Mexico

Panama

Russian Federation

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

After all the subjects complete their study conclusion contact, occurring within 30 days of the projected study conclusion date of the late enrolled subject, that is, 26 months (790 days) from the enrolment date of the last subject AND the release of all polymerase chain reaction (PCR) test results for the HZ rash lesion samples

Una vez que todos los sujetos completen el contacto de conclusión del estudio, que ocurrirá dentro de los 30 días de la fecha estimada de conclusión del estudio, que será 26 meses (790 días) desde la fecha de reclutamiento del último sujeto incluido y se produzca la liberación de todos los resultados de las pruebas de reacción en cadena de la polimerasa (PCR) correspondientes a las muestras obtenidas de lesiones de exantema herpético.

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

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:

580

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

870

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

Yes

F.3.2

Patients

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

500

F.4.2

For a multinational trial

F.4.2.1

In the EEA

793

F.4.2.2

In the whole clinical trial

1426

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)

After study conclusion, placebo recipients may be offered cross-over vaccination with HZ/su, if supported by study results

Una vez concluido del estudio, a los sujetos que recibieron placebo se les podrá ofrecer la vacuna con HZ/su, dependiendo de los resultados del estudio

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

2019-08-13

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-06-24

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

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