Clinical Trials Register

Summary
EudraCT Number:	2015-002478-19
Sponsor's Protocol Code Number:	SHP616-300
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:	2016-01-13
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

2015-002478-19

A.3

Full title of the trial

A Phase 3, Randomized, Double-blind, Placebo-controlled, Two-period, Three-sequence, Partial Crossover Study to Evaluate the Efficacy and Safety of Subcutaneous Administration of 2000 U of C1 Esterase Inhibitor [Human] Liquid for Injection for the Prevention of Angioedema Attacks in Adolescents and Adults with Hereditary Angioedema

Estudio de fase 3, aleatorizado, doble ciego, controlado con placebo, cruzado parcialmente, de dos períodos y tres secuencias para evaluar la eficacia y la seguridad de la administración subcutánea de 2000 U de un inhibidor de la esterasa C1 (humana) en líquido inyectable para la prevención de las crisis de angioedema en adolescentes y adultos con angioedema hereditario

A.3.1

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

Study to determine the efficacy and safety of C1 Esterase Inhibitor liquid for injection compared to placebo in the prevention of Angioedema attacks in adolescents and adults with hereditary angioedema.

Estudio para evaluar la eficacia y la seguridad de la administración subcutánea de un inhibidor de la esterasa C1 (humana) en líquido inyectable en comparación con placebo para la prevención de las crisis de angioedema en adolescentes y adultos con angioedema hereditario

A.4.1

Sponsor's protocol code number

SHP616-300

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	Shire ViroPharma, 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	Shire ViroPharma, Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Shire ViroPharma, Inc.
B.5.2	Functional name of contact point	Howard Mayer
B.5.3	Address:
B.5.3.1	Street Address	300 Shire Way
B.5.3.2	Town/ city	Lexington
B.5.3.3	Post code	MA 02421
B.5.3.4	Country	United States
B.5.4	Telephone number	+34900834223
B.5.6	E-mail	RegistroEspanolDeEstudiosClinicos@druginfo.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	C1 esterase inhibitor liquid for injection
D.3.2	Product code	SHP616
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	C1 Esterase Inhibitor (human)
D.3.9.3	Other descriptive name	COMPLEMENT C1 ESTERASE INHIBITOR
D.3.9.4	EV Substance Code	SUB22696
D.3.10	Strength
D.3.10.1	Concentration unit	IU/ml international unit(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	500
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	Yes
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Firazyr
D.2.1.1.2	Name of the Marketing Authorisation holder	Shire Orphan Therapies GmbH
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	Yes
D.2.5.1	Orphan drug designation number	EU/3/03/133
D.3 Description of the IMP
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	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ICATIBANT
D.3.9.1	CAS number	130308-48-4
D.3.9.4	EV Substance Code	SUB08104MIG
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	10
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	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	Solution for injection
D.8.4	Route of administration of the placebo	Subcutaneous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

hereditary angioedema

Angiodema hereditario

E.1.1.1

Medical condition in easily understood language

Swelling and/or painful attacks in teenagers and adults with Hereditary Angioedema (HAE).

Inflamación y/o ataques dolorosos en adolescentes y adultos con angioedema hereditario (AEH).

E.1.1.2

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	18.1
E.1.2	Level	PT
E.1.2	Classification code	10019860
E.1.2	Term	Hereditary angioedema
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

The primary objective of this study is to demonstrate superior efficacy of SC administration of 2000 U C1 esterase inhibitor [human] liquid for injection for the prevention of angioedema attacks relative to placebo based on the normalized number of attacks (NNA) during a treatment period.

El primer objetivo del ensayo es demostrar la eficacia superior de la administración SC de 2000 U de un inhibidor de la esterasa C1 (humana) en líquido inyectable para la prevención de las crisis de angioedema en comparación con placebo basándose en el número normalizado de crisis (NNC) durante un período de tratamiento

E.2.2

Secondary objectives of the trial

The key secondary objective is to demonstrate the superior efficacy of SC administration of 2000 U C1 esterase inhibitor [human] liquid for injection for the prevention of angioedema attacks relative to placebo as measured by the proportion of subjects meeting the criterion of at least 50% reduction in the NNA during the 2000 U C1 esterase inhibitor [human] liquid for injection treatment period relative to the placebo period.

El objetivo secundario fundamental consiste en demostrar la eficacia superior de la administración SC de 2000 U de un inhibidor de la esterasa C1 (humana) en líquido inyectable para la prevención de las crisis de angioedema en comparación con placebo, determinada mediante la proporción de sujetos que cumplan el criterio de una reducción del 50%, como mínimo, del NNC durante el período del tratamiento con 2000 U del inhibidor de la esterasa C1 (humana) en líquido inyectable en relación con el período de tratamiento con placebo.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Be ?12 years of age.
2. Have a diagnosis of HAE (Type I or II) and a functional C1 INH level less than 50% of normal.
3. Meet one of the following criteria (attack rate may be based on subject recall in conjunction with the subject's medical records):
a. If subject is adult (>18 years of age) and currently receiving prophylactic therapy with C1 INH, have a history of ?2.0 angioedema attacks per month (average) during the 3 consecutive months prior to starting prevention therapy.
OR
b. If subject is adolescent (>12 and <18 years of age) or adult and not receiving
prophylactic therapy with C1 INH, have a history of ?2.0 angioedema attacks
per month (average) during the 3 consecutive months prior to the screening
visit.
OR
c. If subject is adult (>18 years of age) and currently receiving a stable dose of
attenuated androgens, have a history of ?2.0 angioedema attacks per month
(average) during the 3 consecutive months prior to the screening visit.
4. For subjects ?18 years of age, be willing to receive treatment with icatibant for any angioedema attacks that occur during the study that, in the opinion of the healthcare care provider, require medical intervention. Note: For subjects >12 to <18 years of age, standard of care therapy per local protocols should be provided.
5. Agree to adhere to the protocol-defined schedule of assessments.
6. If female, must have a negative serum beta human chorionic gonadotrophin (ß-hCG) pregnancy test at the screening visit and must have a negative urine pregnancy test prior to the first dose of investigational product (Visit 1a), and agree to comply with any applicable contraceptive requirements of the protocol.
7. If male, be surgically sterile or agree to follow an acceptable method of birth control (eg, abstinence, barrier control) from the screening visit through 2 months after the last dose of investigational product.
8. If an adult (?18 years of age), be informed of the nature of the study and provide written informed consent before any study-specific procedures.
OR
If a child (<18 years of age), have a parent(s)/legal guardian who is informed of the nature of the study provide written informed consent for the child to participate in the study before any study-specific procedures are performed (with assent from the child when appropriate). Alternatively, certain sites/Independent Reviewing Authorities may permit adolescents who are <18 years of age to be informed of the nature of the study and provide written informed consent without consent from a parent(s)/legal guardian.

1. Edad ? 12 años.
2. Diagnóstico de AEH (tipo I o II) y concentración de INH C1 funcional < 50% de la normal.
3. Cumplimiento de uno de los criterios siguientes (la frecuencia de crisis puede basarse en el recuerdo del sujeto además de en el historial clínico):
a. En caso de que el paciente sea adulto (>18 años de edad), esté recibiendo tratamiento profiláctico con INH C1 y tenga antecedentes de ?2,0 crisis de angioedema al mes (promedio) durante los 3 meses consecutivos antes de comenzar el tratamiento preventivo.
O
b. En caso de que el paciente sea adolescente (de entre 12 y 18 años de edad) o adulto, no esté recibiendo tratamiento profiláctico con INH C1 y tenga antecedentes de ? 2,0 crisis de angioedema al mes (promedio)1 durante los 3 meses consecutivos antes de la visita de selección.
O
c. En caso de que el paciente sea adulto, esté recibiendo una dosis estable de andrógenos atenuados y tenga antecedentes de ? 2,0 crisis de angioedema al mes (promedio)1 durante los 3 meses consecutivos antes de la visita de selección.
4. En los sujetos mayores de 18 años, disposición a recibir tratamiento con icatibant ante cualquier crisis de angioedema que se produzca durante el estudio que, en opinión del profesional sanitario, requiera intervención médica. Nota: A los sujetos de entre 12 y menos 18 años de edad se les proporcionará el tratamiento de referencia conforme a los protocolos locales.
5. Compromiso de cumplir el calendario de evaluaciones definido en el protocolo.
6. En caso de ser mujer, resultado negativo en una prueba de embarazo (determinación de subunidad beta de la gonadotropina coriónica humana, ß-hCG) en suero en la visita de selección y resultado negativo en una prueba de embarazo en orina antes de la primera dosis del producto en investigación (visita 1a) y compromiso de cumplir los requisitos anticonceptivos aplicables del protocolo.
7. En caso de ser varón, esterilización quirúrgica o compromiso de utilizar un método anticonceptivo aceptable (por ejemplo, abstinencia o método de barrera) desde la visita de selección hasta dos meses después de la última dosis del producto en investigación.
8. En caso de ser adulto (?18 años), recepción de información sobre la naturaleza del estudio y otorgamiento del consentimiento informado por escrito antes de realizar ningún procedimiento específico del estudio.
O
En caso de ser niño (< 18 años), otorgamiento del consentimiento informado por escrito por parte de un progenitor o tutor legal que esté informado de la naturaleza del estudio para que el niño participe en el estudio antes realizar ningún procedimiento específico del estudio (con el asentimiento del niño cuando proceda). Por otro lado, algunos centros u organismos de revisión independientes (ORI) pueden permitir que se informe a adolescentes menores de 18 años de la naturaleza del estudio y otorguen su consentimiento informado por escrito sin el consentimiento de un progenitor o tutor legal.

E.4

Principal exclusion criteria

1. Adults (>18 years of age) receiving prophylactic IV CINRYZE that exceeds the approved dosing regimen of 1000 U every 3 or 4 days (receiving a weekly dose >2000 U).
2. Adolescents (>12 and <18 years of age) currently receiving prophylactic therapy with C1 INH.
3. Have had signs or symptoms of an angioedema attack within 2 days prior to the first dose of the investigational product in Treatment Period 1.
4. Have received any C1 INH therapy or any blood product for the treatment or prevention of angioedema attacks within 3 calendar days prior to the first dose of investigational product in Treatment Period 1.
5. If female, have started or changed the dose of any hormonal contraceptive regimen or hormone replacement therapy (ie, estrogen/progestin containing products) within 2 months prior to the screening visit.
6. Have a history of hypercoagulability (abnormal blood clotting) or other predisposition for thromboembolism.
7. Have a diagnosis of acquired angioedema or known presence of anti-C1 INH
antibodies.
8. Have a history of allergic reaction to C1 INH products, including CINRYZE (or any components of CINRYZE), or other blood products.
9. Be pregnant or breastfeeding.
10. Have received an investigational drug within 30 days prior to the first dose of
investigational product in Treatment Period 1.
11. Have, as determined by the investigator and/or the sponsor?s medical monitor, any surgical or medical condition that could interfere with the administration of investigational product or interpretation of study results.

1. Adultos (>18 años de edad) que reciben CINRYZE IV profiláctico en cantidad superior a la pauta posológica aprobada de 1000 U cada 3 o 4 días (dosis semanal > 2000 U).
2. Adolescentes (de entre 12 y 18 años de edad) que reciben actualmente tratamiento profiláctico con INH C1.
3. Signos o síntomas de una crisis de angioedema en los 2 días previos a la primera dosis del producto en investigación en el primer período de tratamiento.
4. Recepción de cualquier tratamiento con INH C1 o cualquier hemoderivado para el tratamiento o la prevención de las crisis de angioedema en los 3 días naturales previos a la primera dosis del producto en investigación en el primer período de tratamiento.
5. En mujeres, si ha comenzado o modificado la dosis de algún tratamiento anticonceptivo u hormonal sustitutivo (es decir, medicamentos que contienen estógenos o progesterona) en los 2 meses anteriores a la visita de selección
6. Antecedentes de hipercoagulabilidad (coagulación anormal de la sangre) u otro tipo de predisposición a sufrir tromboembolias.
7. Diagnóstico de angioedema adquirido o presencia conocida de anticuerpos anti-INH C1.
8. Antecedentes de reacción alérgica a productos con INH C1, incluido CINRYZE (o a cualquier componente de Cinryze), o a otros hemoderivados.
9. Embarazo o lactancia materna.
10. Recepción de un fármaco experimental en los 30 días previos a la primera dosis del producto en investigación en el primer período de tratamiento.
11. Presencia, según lo determinado por el investigador o el monitor médico del promotor, de cualquier proceso quirúrgico o médico que pueda interferir en la administración del producto en investigación o la interpretación de los resultados del estudio.

E.5 End points

E.5.1

Primary end point(s)

The normalized number of attacks (NNA) recorded during each treatment period. The NNA is computed as the number of attacks per month (ie, 30.4 days) of exposure (NNA = 30.4 x [number of attacks during treatment period]/[days of treatment period]). If a subject discontinues during the treatment period, the denominator of the NNA will be the days on treatment for that subject; this is equivalent to the last observation carried forward imputation method to impute the missing information following the subject's discontinuation

NNC registrado durante cada período de tratamiento. El NNC se calcula como el número de crisis por mes (es decir, 30,4 días) de exposición (NNC = 30,4 x [número de crisis durante el período de tratamiento]/[días del período de tratamiento]). Cuando un sujeto se retire durante el período de tratamiento, el denominador del NNC serán los días de tratamiento de ese sujeto; esto equivale al método de extrapolación de la última observación para imputar la información omitida tras la retirada del sujeto.

E.5.1.1

Timepoint(s) of evaluation of this end point

14 weeks

14 semanas

E.5.2

Secondary end point(s)

The clinical response to treatment relative to placebo. This is defined as achieving a ? 50% reduction in the NNA (PR) during the 2000 U C1 esterase inhibitor [human] liquid for injection treatment period relative to the placebo period.

Respuesta clínica al tratamiento en comparación con placebo. Se define como la consecución de una reducción ? 50% del NNC (PR) durante el período de tratamiento con 2000 U del inhibidor de la esterasa C1 (humana) en líquido inyectable en comparación con el período de placebo.

E.5.2.1

Timepoint(s) of evaluation of this end point

14 weeks

14 semanas

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

E.6.3

Therapy

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

Yes

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

Canada

Germany

Hungary

Israel

Romania

Spain

United States

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

Last patient last visit

Último paciente última visita

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 months

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:

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)

Yes

F.1.1.6.1

Number of subjects for this age range:

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Children below the age of 18 years (Only provide assent)

Niños menores de 18 años (Se aportará su Asentimiento)

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

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)

Subjects completing the study will resume standard of care therapy available

Los pacientes que completen el estudio reanudarán el tratamiento de terapia habitual disponible

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

2016-02-15

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-01-12

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2017-07-24

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