Clinical Trials Register

Summary
EudraCT Number:	2013-000366-11
Sponsor's Protocol Code Number:	TP0503
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2013-07-12
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

2013-000366-11

A.3

Full title of the trial

A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC)

Estudio aleatorizado, controlado con producto activo, con doble enmascaramiento y periodo de extensión abierto para evaluar la eficacia, seguridad y tolerabilidad a largo plazo de 3,2 g/día de TP05 para el tratamiento de la colitis ulcerosa (CU) activa

A.3.1

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

Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05.

Estudio para probar si TP05 a una dosis de 3.2 g/día es seguro, se tolera bien y funciona para el tratamiento de la colitis ulcerosa activa. El tratamiento se asignará por azar a pacientes e investigadores sin saber si el paciente está recibiendo TP05 o la terapia estándar. Este fase del estudio "ciego" irá seguido por otro periodo en el que todos los pacientes recibirán TP05.

A.4.1

Sponsor's protocol code number

TP0503

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	Tillotts Pharma AG
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	Tillotts Pharma AG
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	Robarts Clinical Trials Inc.
B.5.2	Functional name of contact point	Clinical Research Manager
B.5.3	Address:
B.5.3.1	Street Address	Pietersbergweg 17, Trinity Building C
B.5.3.2	Town/ city	Amsterdam
B.5.3.3	Post code	1105 BM
B.5.3.4	Country	Netherlands
B.5.6	E-mail	Tanja.vanviegen@robartsinc.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.3.2	Product code	TP05
D.3.4	Pharmaceutical form	Gastro-resistant 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	MESALAZINE
D.3.9.1	CAS number	89-57-6
D.3.9.2	Current sponsor code	TP05
D.3.9.4	EV Substance Code	SUB08782MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	4.8
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	Comparator
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	Asacol
D.2.1.1.2	Name of the Marketing Authorisation holder	Tillotts Pharma
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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.3.4	Pharmaceutical form	Gastro-resistant tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
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	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	Gastro-resistant 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

Ulcerative colitis

Colitis Ulcerosa

E.1.1.1

Medical condition in easily understood language

Ulcerative colitis

Colitis Ulcerosa

E.1.1.2

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	16.0
E.1.2	Level	LLT
E.1.2	Classification code	10045365
E.1.2	Term	Ulcerative colitis
E.1.2	System Organ Class	100000004856

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Induction:
The primary objective of the Induction phase is to determine if 8 weeks of treatment with 3.2 g/day of TP05 is not inferior to 3.2 g/day of Asacol? in inducing clinical and endoscopic remission (a
score ? 2 points on the Mayo scoring scale with no individual sub-score > 1 point) in subjects with active mild to moderate Ulcerative Colitis (UC).

Open Label Extension (OLE):
The primary objective of the OLE is to assess the safety and tolerability of TP05 over a 26-week period in subjects achieving endoscopic and clinical remission or exhibiting a response during the initial phase of TP0503. Maintenance of clinical remission by TP05 will also be assessed by determining the proportion of patients in clinical remission at the final visit.

Objetivo principal de la fase de inducción
El objetivo principal de la fase de inducción consiste en determinar si un tratamiento de 8 semanas con 3,2 g/día de TP05 no es inferior a 3,2 g/día de Asacol™ en términos de remisión clínica y endoscópica (puntuación ≤ 2 puntos en la escala Mayo, sin subpuntuación individual > 1 punto).

Objetivo principal del periodo de extensión abierto:
El objetivo principal del periodo de extensión abierto (OLE) consiste en evaluar la seguridad y la tolerabilidad de TP05 durante un periodo de 26 semanas en sujetos que logren remisión clínica y endoscópica o bien que muestren una respuesta durante la fase inicial de TP0503. El mantenimiento de la remisión clínica debido a TP05 se evaluará también a través de la proporción de pacientes en remisión clínica en la visita final.

E.2.2

Secondary objectives of the trial

Induction:
Proportion of subjects achieving:
- endoscopic remission at Week 8
- clinical remission at Week 8 or 12
- a rectal bleeding sub-score of 0 at Week 8 or 12
- clinical remission at both Week 8 and 12
- a clinical and endoscopic response at Week 8
- a clinical response at Week 12
- a clinical response at Week 8 and 12
Also:
- change in Mayo scores and PMCS at Week 8 and 12
- change in rectal bleeding and stool frequency at Week 8 and 12

OLE:
To assess whether a dose escalation to 4.8 g/day of TP05 is effective in inducing remission in subjects who fail to respond to either Asacol? or TP05 during induction.
Quality of life will also be assessed using the SF-36, EQ-5D, WPAI-UC, subject and physician global ratings.
Exploratory analyses of potential associations between patient characteristics and clinical remission as well as AEs or SAEs will be conducted as well as the relationship between faecal calprotectin
levels and UC disease severity.

INDUCCION:proporción de sujetos que logra:remisión endoscópica en la semana 8, la remisión clínica en la semana 8 ó12. Una subpunt. de rectorragia = a 0 en la semana 8 ó 12. La remisión clínica tanto en sem. 8 como en la 12. Respuesta clínica y endoscópica en sem.8.Respuesta clínica en sem.12, así como tanto en sem. 8 como en 12. Cambios en las puntuaciones Mayo y PMCS en las sem. 8 y 12, y cambios en la rectorragia y la frecuencia de deposiciones tanto en la semana 8 /12. EXTENSION: Evaluar si un aumento de la dosis a 4,8 g/día de TP05 es eficaz para la remisión en sujetos que no respondan a Asacol™ o a TP05 durante la inducción. Se evaluará la calidad de vida a través de SF-36, EQ-5D, WPAI-UC y las valoraciones globales del médico y el sujeto. Se llevarán a cabo análisis exploratorios de las posibles asociaciones entre las características del paciente y la remisión clínica, así como los AA o AAG, o la relación entre la concentración de calprotectina fecal y la gravedad de la CU.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Induction:
(1) Male or non-pregnant, non-lactating females, 18 years of age or older. Females of child bearing potential must have a negative serum pregnancy test prior to randomisation, and must use a hormonal (oral, implantable or injectable) or barrier method of birth control throughout the study. Females unable to bear children must have documentation of such in the source records (i.e., tubal ligation, hysterectomy, or post-menopausal [defined as a minimum of one year since the last menstrual period]).
(2) Documented diagnosis of UC with disease extending at least 15 cm from the anal verge.
(3) Active UC defined by:
a. Mayo score of > 5
b. Sigmoidoscopy component score ? 2 confirmed by central review and
c. Rectal bleeding component score ? 1
(4) Ability of the subject to participate fully in all aspects of this clinical trial.
(5) Written informed consent must be obtained and documented.

OLE:
(1) Attendance at the Week 8 visit and completion of disease activity assessments prior to enrolment in OLE at Week 12 (responders or remitters) or Week 8 (non-responders).
(2) At least 75% compliance with study medication in the induction phase.

Inducción:
(1) Hombres o mujeres que no estén embarazadas o en periodo de lactancia de 18 años o más. Antes de su aleatorización, las mujeres en edad fértil deben realizarse una prueba de embarazo en suero y obtener un resultado negativo. También deben utilizar un método anticonceptivo hormonal (oral, implantable o inyectable) o de barrera durante el transcurso del estudio. Las mujeres infértiles deben documentar tal situación en su historial de origen (ligadura de trompas, histerectomía o estado postmenopáusico [definido como un año como mínimo desde la última menstruación]).
(2) Diagnóstico documentado de CU con extensión de la enfermedad de un mínimo de 15 cm desde el margen externo del ano.
(3) CU activa, definida como:
a. Puntuación Mayo > 5.
b. Puntuación de la parte de sigmoidoscopia ≥ 2 (confirmada a través de una revisión central).
c. Y puntuación de la parte de rectorragia ≥ 1.
(4) Capacidad de participación plena en todos los aspectos de este ensayo clínico por parte del sujeto.
(5) Debe obtenerse y documentarse un consentimiento informado por escrito.
Extensión:
(1) Asistencia a la visita de la semana 8 y finalización de las evaluaciones de la actividad de la enfermedad previas a la inclusión en el OLE en la semana 12 (sujetos con respuesta o remisión) o en la semana 8 (sujetos sin respuesta).
(2) Un cumplimiento terapéutico con la medicación del estudio como mínimo del 75 % en la fase de inducción.

E.4

Principal exclusion criteria

(1) Severe UC defined by the following criteria:
≥ 6 bloody stools daily with one or more of the following:
a. oral temperature > 37.8°C or > 100.0°F
b. pulse > 90 beats/min
c. haemoglobin < 10 g/dL
(2) Treatment with oral mesalamine at a dose of > 2.4 g/day within 4 weeks prior to randomisation.
(3) Treatment with topical therapy (mesalamine or corticosteroids) within 2 weeks prior to randomisation.
(4) Treatment with systemic or rectal steroids within 4 weeks prior to randomisation.
(5) Treatment with immunosuppressants within 6 weeks prior to randomisation.
(6) Treatment with infliximab or other biologics within 3 months prior to randomisation.
(7) Treatment with antibiotics within 7 days prior to randomisation.
(8) Treatment with probiotics within 7 days prior to randomisation
(9) Treatment with anti-diarrhoeals within 7 days prior to randomisation
(10) Treatment with nicotine patch within 7 days prior to randomisation.
(11) Received any investigational drug within 30 days prior to randomisation.
(12) History of colectomy or partial colectomy.
(13) History of definite dysplasia in colonic biopsies.
(14) Crohn’s disease.
(15) Immediate or significant risk of toxic megacolon.
(16) Known bleeding disorders.
(17) Hypersensitivity to salicylates, aspirin, sulfasalazine or 5-ASA.
(18) Serum creatinine > 1.5 times the upper limit of the normal range.
(19) Aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin or alkaline phosphatase > 2 times the upper limit of the normal range.
(20) Serious underlying disease other than UC which in the opinion of the investigator may interfere with the subject’s ability to fully participate in the study.
(21) History of alcohol or drug abuse which in the opinion of the investigator may interfere with the subject’s ability to comply with the study procedures.
(22) Stools positive for Clostridium difficile toxin.
(23) Pregnant or lactating women.
(24) Prior enrolment in the study.
OLE:
(1) Withdrawal from the induction phase prior to the Week 8 visit.

Inducción:
(1) CU grave, definida por los criterios siguientes:
 6 deposiciones hemorrágicas al día y una o más de las situaciones siguientes:
a. Temperatura oral > 37,8 C o > 100,0 F.
b. Pulso > 90 latidos/min.
c. Hemoglobina < 10 g/dl.
(2) Tratamiento oral con mesalamina a una dosis > 2,4 g/día en las 4 semanas anteriores a la aleatorización.
(3) Tratamiento con terapias tópicas (mesalamina o corticoesteroides) en las 2 semanas previas a la aleatorización
(4) Tratamiento con esteroides sistémicos o rectales en las 4 semanas anteriores a la aleatorización.
(5) Tratamiento con inmunodepresores en las 6 semanas anteriores a la aleatorización.
(6) Tratamiento con infliximab u otros agentes biológicos en los 3 meses anteriores a la aleatorización.
(7) Tratamiento con antibióticos en los 7 días anteriores a la aleatorización.
(8) Tratamiento con probióticos en los 7 días anteriores a la aleatorización.
(9) Tratamiento con antidiarreicos en los 7 días anteriores a la aleatorización.
(10) Tratamiento con parches de nicotina en los 7 días anteriores a la aleatorización.
(11) Haber recibido algún fármaco en investigación en los 30 días anteriores a la aleatorización.
(12) Antecedentes de colectomía o colectomía parcial.
(13) Antecedentes de displasia confirmada en las biopsias de colon.
(14) Enfermedad de Crohn.
(15) Riesgo inmediato o significativo de megacolon tóxico.
(16) Alteraciones hemorrágicas conocidas.
(17) Hipersensibilidad a salicilatos, aspirina, sulfasalazina o 5-ASA.
(18) Creatinina sérica > 1,5 veces el límite superior del rango normal.
(19) Aspartato aminotransferasa (AST), alanina aminotransferasa (ALT), bilirrubina total o fosfatasa alcalina > 2 veces el límite superior del intervalo normal.
(20) Enfermedad subyacente grave distinta de la CU que en opinión del investigador pueda interferir con la capacidad de participación plena en el estudio por parte del sujeto.
(21) Antecedentes de alcoholismo o toxicomanía que en opinión del investigador puedan interferir con la capacidad de cumplimiento de los procedimientos del estudio por parte del sujeto.
(22) Deposiciones con resultado positivo para las toxinas producidas por Clostridium difficile.
(23) Mujeres embarazadas o en periodo de lactancia.
(24) Inclusión anterior en el estudio.
Extensión:
(1) Retirada de la fase de inducción antes de la visita de la semana 8.

E.5 End points

E.5.1

Primary end point(s)

The primary efficacy endpoint is the proportion of subjects in clinical and endoscopic remission after 8 weeks of treatment, defined as achieving a Mayo score of ? 2 points, with no individual sub-score > 1 point at the Week 8 visit.

La variable principal de eficacia es la proporción de sujetos que consiguen la remisión clínica y endoscópica, después de 8 semanas de tratamiento, definida como una puntuación Mayo ≤ 2 puntos, sin subpuntuación individual > 1 punto en la semana 8.

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 8.

Semana 8.

E.5.2

Secondary end point(s)

Secondary efficacy endpoints based on changes in the Mayo score and the PMCS include:
- the proportion of subjects achieving endoscopic remission (endoscopic sub-score of 0) at Week 8
- the proportion of subjects achieving clinical remission at Week 8
- the proportion of subjects achieving a rectal bleeding sub-score of 0 at Week 8
- the proportion of subjects achieving clinical remission at Week 12
- the proportion of patients achieving a rectal bleeding sub-score of 0 at Week 12
- the proportion of subjects achieving clinical remission at both Week 8 and Week 12
- the proportion of subjects achieving a clinical and endoscopic response at Week 8
- the proportion of subjects achieving a clinical response at Week 12
- the proportion of subjects achieving a clinical response at both Week 8 and Week 12
- the changes in Mayo scores and PMCS at Week 8 and Week 12, respectively
- the changes in rectal bleeding and stool frequency at both Week 8 and Week 12

Valoraciones de eficacia secundaria basadas en cambios en la puntuación Mayo y PMCs incluyen:
-La proporción de sujetos que logra la remisión endoscópica (subpuntuación de endoscopia igual a 0) en la semana 8.
-La proporción de sujetos que logra la remisión clínica en la semana 8.
-La proporción de sujetos que logran una subpuntuación de rectorragia igual a 0 en la semana 8.
-La proporción de sujetos que logra la remisión clínica en la semana 12.
-La proporción de sujetos que logra una subpuntuación de rectorragia igual a 0 en la semana 12.
-La proporción de sujetos que logra la remisión clínica tanto en la semana 8 como en la 12.
-La proporción de sujetos que logra una respuesta clínica y endoscópica en la semana 8.
-La proporción de sujetos que logra una respuesta clínica en la semana 12.
-La proporción de sujetos que logra una respuesta clínica tanto en la semana 8 como en la 12.
-Los cambios en las puntuaciones Mayo y PMCS en las semanas 8 y 12, respectivamente.
-Los cambios en la rectorragia y la frecuencia de deposiciones tanto en la semana 8 como en la 12.

E.5.2.1

Timepoint(s) of evaluation of this end point

Week 8 and 12.

Semana 8 y 12

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

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

Yes

E.6.13.1

Other scope of the trial description

Tolerability, Non-inferiority

Tolerabilidad, No-inferioridad

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

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Double-blind parallel phase, followed by open label extension phase

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

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

106

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

Belarus

Canada

Russian Federation

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

All subjects will be contacted via telephone for a post-treatment follow-up 4 weeks after the last dose of study drug. Any SAEs will be recorded.

The end of the trial is defined as the date of the last patient contacted by telephone 4 weeks after the last dose of study drug.

Se contactará telefónicamente a todos los sujetos para un seguimiento post tratamiento, 4 semanas después de la última dosis de medicación. Se recogerán todos los acontecimientos adversos graves.
El final del estudio, queda definido como la fecha de último contacto telefónico, 4 semanas después de recibir la última dosis 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

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:

752

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

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

576

F.4.2.2

In the whole clinical trial

800

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 a patient has completed/terminated their study participations, long term care for the participant will remain the responsibility of their primary treating physicians.

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

2013-10-07

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-09-16

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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