Clinical Trials Register

Summary
EudraCT Number:	2011-004590-90
Sponsor's Protocol Code Number:	3415A-001
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:	2011-11-28
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

2011-004590-90

A.3

Full title of the trial

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Adaptive Design Study of the Efficacy, Safety, and Tolerability of a Single Infusion of MK-3415 (Human Monoclonal Antibody to Clostridium difficile toxin A), MK-6072 (Human Monoclonal Antibody to Clostridium difficile toxin B), and MK-3415A (Human Monoclonal Antibodies to Clostridium difficile toxin A and toxin B) in Patients Receiving Antibiotic Therapy for Clostridium difficile Infection(MODIFY I)

Estudio de fase III aleatorizado, doble ciego y controlado con placebo, de diseño adaptativo, de la eficacia, la seguridad y la tolerabilidad de una sola infusión de MK 3415 (anticuerpo monoclonal humano frente a la toxina A de Clostridium difficile), MK 6072 (anticuerpo monoclonal humano frente a la toxina B de Clostridium difficile) y MK 3415A (anticuerpos monoclonales humanos contra las toxinas A y B de Clostridium difficile) en pacientes sometidos a tratamiento antibiótico por infección por Clostridium difficile (MODIFY I)

A.3.1

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

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Adaptive Design Study of the Efficacy, Safety, and Tolerability of a Single Infusion of MK-3415, MK-6072, and MK-3415A in Patients Receiving Antibiotic Therapy for Clostridium difficile Infection(MODIFY I)

Estudio de fase III aleatorizado, doble ciego y controlado con placebo, de diseño adaptativo, de la eficacia, la seguridad y la tolerabilidad de una sola infusión de MK 3415, MK 6072 y MK 3415A en pacientes sometidos a tratamiento antibiótico por infección por Clostridium difficile (MODIFY I)

A.3.2

Name or abbreviated title of the trial where available

MODIFY I

A.4.1

Sponsor's protocol code number

3415A-001

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	Merck Sharp & Dohme Corp.
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	Merck Sharp & Dohme Corp.
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	Merck Sharp & Dohme Corp.
B.5.2	Functional name of contact point	Merck Sharp & Dohme Corp.
B.5.3	Address:
B.5.3.1	Street Address	One Merck Drive, PO Box 100
B.5.3.2	Town/ city	Whitehouse Station, NJ
B.5.3.3	Post code	08889-0100
B.5.3.4	Country	United States
B.5.4	Telephone number	2673057019
B.5.5	Fax number	N/AN/AN/A
B.5.6	E-mail	mary.beth.dorr@merck.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	MK-3415
D.3.2	Product code	MK-3415
D.3.4	Pharmaceutical form	Solution for infusion
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.3.9.2	Current sponsor code	MK 3415
D.3.10	Strength
D.3.10.1	Concentration unit	mg/kg milligram(s)/kilogram
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	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.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	MK-6072, MDX-1388, CDB1
D.3.2	Product code	MK-6072
D.3.4	Pharmaceutical form	Solution for infusion
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.3.9.2	Current sponsor code	MK 6072
D.3.10	Strength
D.3.10.1	Concentration unit	mg/kg milligram(s)/kilogram
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	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.IMP: 3
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	MK-3415A (MK-3415/MK-6072)
D.3.2	Product code	MK-3415 A
D.3.4	Pharmaceutical form	Solution for infusion
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.3.9.2	Current sponsor code	MK 3415
D.3.10	Strength
D.3.10.1	Concentration unit	mg/kg milligram(s)/kilogram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	MK-6072
D.3.10	Strength
D.3.10.1	Concentration unit	mg/kg milligram(s)/kilogram
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	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	Injection
D.8.4	Route of administration of the placebo	Intravenous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

recurrence of Clostridium difficile infection (CDI)

recurrencia de la infección por C. difficile (ICD).

E.1.1.1

Medical condition in easily understood language

recurrence of Clostridium difficile infection (CDI)

recurrencia de la infección por C. difficile (ICD).

E.1.1.2

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.0
E.1.2	Level	LLT
E.1.2	Classification code	10054236
E.1.2	Term	Clostridium difficile infection
E.1.2	System Organ Class	10021881 - Infections and infestations

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Primary Objective 1: To determine if treatment with a single infusion of combined monoclonal antibody therapy (MK-3415A) with SOC therapy decreases the proportion of patients with CDI recurrence over a period of 12 weeks as compared to treatment with a single infusion of individual monoclonal antibody therapy (MK-3415 or MK-6072) with SOC therapy. (Read the rest of the Primary Objectives in the protocol)

Objetivo principal 1: Determinar si el tratamiento con una sola infusión de tratamiento con anticuerpos monoclonales combinados (MK 3415A) junto con el TH reduce la proporción de pacientes con recurrencia de la ICD durante un período de 12 semanas en comparación con el tratamiento con una sola infusión de tratamiento con anticuerpos monoclonales individuales (MK 3415 o MK 6072) junto con el TH. (Leer el resto de objetivos principales en el protocolo)

E.2.2

Secondary objectives of the trial

Secondary Objective 1: To evaluate, in the subset of patients who achieve a clinical cure for the initial CDI episode, if treatment with a single infusion of MK-3415A with SOC therapy decreases the proportion of patients with CDI recurrence over a period of 12 weeks as compared to treatment with a single infusion of placebo and SOC therapy.(Read the rest of the Secondary Objectives in the protocol)

Objetivo secundario 1:Evaluar, en el subgrupo de pacientes que logren curación clínica del episodio de ICD inicial, si el tratamiento con una sola infusión de MK 3415A con TH reduce la proporción de pacientes con recurrencia de la ICD durante un período de 12 semanas en comparación con el tratamiento con una sola infusión de placebo y el TH.(Leer el resto de objetivos secundarios en el protocolo)

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

ICF( version 00 extensión 9 months 3-nov-2011)
ICF( Versión 00 Genetic and further samples version 00 date 9-11-11)

HIP y CI (versión 00 extensión 9 meses 3-nov-2011)
HIP y CI (Versión 00 Genético y Muestras Futuras del 9 de Noviembre de 2011)

E.3

Principal inclusion criteria

1. Participant must be 18 years of age or older.
2. Participant has a diagnosis of CDI as defined by:
a. Presence of diarrhea, as defined by passage of 3 or more loose stools in 24 or fewer hours, AND
b. A positive stool test for toxigenic C. difficile.
3. Participant must be receiving SOC therapy for CDI. SOC therapy is defined as the receipt of oral metronidazole, oral vancomycin, IV metronidazole concurrent with oral vancomycin, oral fidaxomicin, or oral fidaxomicin concurrent with IV metronidazole.
4. Participant is highly unlikely to become pregnant or to impregnate a partner since they meet at least one of the following criteria: a. A female participant who is not of reproductive potential is eligible without requiring the use of contraception.
A female participant who is not of reproductive potential is defined as: one who has either (1) reached natural menopause (defined as 6 months of spontaneous amenorrhea with serum follicle stimulating hormone (FSH) levels in the postmenopausal range as determined by the local laboratory, or 12 months of spontaneous amenorrhea); (2) 6 weeks post surgical bilateral oophorectomy with or without hysterectomy; or (3) bilateral tubal ligation. Spontaneous amenorrhea does not include cases for which there is an underlying disease that causes amenorrhea (e.g. anorexia nervosa). b. A participant who is of reproductive potential agrees to remain abstinent or use (or have their partner use) 2 acceptable methods of birth control starting at enrollment and through the 12 Week study period. Acceptable methods of birth control are: intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, vasectomy and any registered and marketed hormonal contraceptives that contain an estrogen and/or a progestational agent (including oral, subcutaneous, intrauterine, or intramuscular agents)
5. Participant or legal representative must have voluntarily agreed to participate by providing written informed consent after the nature of the study has been fully explained.

1.Pacientes de 18 o más años de edad.
2.Pacientes con diagnóstico de infección por C. difficile (ICD), definido por:
a.Presencia de diarrea, definida como la evacuación de 3 o más deposiciones sueltas en 24 horas o menos [16]
Y
b.Prueba de heces positiva para la toxina de C. difficile.
3.Los pacientes deberán estar recibiendo, o deberá estar previsto que reciban, un ciclo de 10 a 14 días del TH para la ICD. Se entiende por TH la recepción de metronidazol oral, vancomicina oral, metronidazol intravenoso junto con vancomicina oral, fidaxomicina oral o fidaxomicina oral junto con metronidazol intravenoso.
4.Pacientes con muy escasa probabilidad de quedarse embarazadas o de dejar embarazada a su pareja porque cumplen al menos uno de los criterios siguientes:
a.Las pacientes en edad no fértil podrán participar sin tener que utilizar anticonceptivos. Una mujer que no está en edad fértil se define como la que: (1) ha alcanzado la menopausia natural (definida como 6 meses de amenorrea espontánea con concentraciones séricas de FSH dentro del intervalo posmenopáusico según lo determinado por el laboratorio local, o 12 meses de amenorrea espontánea); (2) se ha sometido a una ovariectomía bilateral con o sin histerectomía 6 semanas antes, o (3) se ha sometido a una ligadura de trompas bilateral. La amenorrea espontánea no incluye los casos en los que existe una enfermedad subyacente que causa amenorrea (p. ej., anorexia nerviosa).
b.Un paciente de cualquier sexo que está en edad fértil se compromete a mantener abstinencia sexual o a utilizar (o hacer que su pareja utilice) 2 métodos anticonceptivos aceptables desde el reclutamiento y durante todo el período de 12 semanas del estudio. Son métodos anticonceptivos aceptables: el dispositivo intrauterino (DIU), el diafragma con espermicida, la esponja anticonceptiva, el preservativo, la vasectomía y los anticonceptivos hormonales registrados y comercializados que contienen un estrógeno, un progestágeno o ambos (incluidos los orales, subcutáneos, intrauterinos o intramusculares).
5.El paciente o su representante legal deberán haber aceptado participar voluntariamente dando su consentimiento informado por escrito después de haber recibido una explicación completa de la naturaleza del estudio.

E.4

Principal exclusion criteria

1. participant with an active chronic diarrheal illness such as, but not limited to, ulcerative colitis or Crohn's disease or with a condition that causes routine passage of loose stool (e.g., an ostomy).
2. Participant with a planned surgery for CDI within 24 hours.
3. Participant has a positive pregnancy test in the 48 hours before the infusion or is unwilling to undergo pregnancy testing if a pre-menopausal female who is not sterilized and therefore has the potential to bear a child.
4. Participant is breast-feeding or plans to breastfeed prior to the completion of the 12-week study period.
5. A female participant who plans to donate ova prior to the completion of the 12-week study period, or a male participant who is planning to impregnate or provide sperm donation prior to the completion of the 12-Week study period.
6. Participant has previously participated in this study or has previously received MK-3415 or MK-6072 (either alone or in combination).
7. Participant plans to donate blood and/or blood products within 6 months following the infusion.
8. Participant has received immune globulin within 6 months prior to receipt of the infusion or is planning to receive immune globulin prior to the completion of the 12-week study period.
9. Treatment with SOC therapy is planned for longer than 14 days
10. Participant has received cholestyramine, rifaximin, or nitazoxanide within 14 days prior to receipt of the infusion or is planning to receive these medications prior to the completion of the 12-week study period.
11. Participant plans to take antiperistaltic agents, such as loperamide (Imodium?) or diphenoxylate
hydrochloride/atropine sulfate (LOMOTIL?), at any time during the 14 days following infusion. Participants receiving opioid medications at the onset of diarrhea may be included if they are on a stable dose or if there is anticipation of a dose decrease or cessation of use.
12. Participant plans to take the probiotic Saccharomyces boulardii at any time following infusion (Day 1) and through the completion of the 12-week study period.
13. Participant has received another investigational study agent within the previous 30 days, or is currently participating in or scheduled to participate in any other clinical trial during the 12- week study period.
14. Participant is not expected to survive for 72 hours.
15. participant has any other condition that, in the opinion of the investigator, would jeopardize the safety or rights of the participant participating in the study, would make it unlikely for the participant to complete the study, or would confound the results of the study.

1.Pacientes con una enfermedad diarreica crónica activa como, entre otras, la colitis ulcerosa o la enfermedad de Crohn, o con una situación en la que evacuan sistemáticamente deposiciones sueltas (p. ej., pacientes con una ostomía).
2.Pacientes en quienes esté prevista una intervención quirúrgica para la ICD en el plazo de 24 horas.
3.Paciente con una prueba de embarazo positiva en las 48 horas previas a la infusión o no dispuesta a someterse a una prueba de embarazo si es una mujer premenopáusica que no está esterilizada y puede, en consecuencia, engendrar un niño.
4.Pacientes que alimentan al pecho a su hijo o tienen previsto hacerlo antes de completar el período del estudio de 12 semanas.
5.Una paciente que tenga previsto donar óvulos antes de completar el período del estudio de 12 semanas o un paciente varón que tenga previsto fecundar o donar semen antes de completar el período del estudio de 12 semanas.
6.Pacientes que hayan participado previamente en este estudio o recibido previamente MK 3415 o MK 6072 (solos o en combinación).
7.Pacientes que prevean donar sangre o hemoderivados en los 6 meses siguientes a la infusión.
8.Pacientes que hayan recibido inmunoglobulinas en los 6 meses previos a la recepción de la infusión o que esté previsto que las reciban antes de completar el período del estudio de 12 semanas.
9.Pacientes en quienes esté prevista la administración del TH durante más de 14 días (p. ej., previsión de una pauta de vancomicina gradual o en pulsos).
10.Pacientes que hayan recibido colestiramina, rifaximina o nitazoxanida en los 14 días previos a la recepción de la infusión o que se prevea que las recibirán antes de completar el período del estudio de 12 semanas.
11.Pacientes que planeen tomar medicación para controlar la diarrea o disminuir el peristaltismo, como loperamida (Immodium ?) o clorhidrato de difenoxilato/sulfato de atropina (Lomotil ?), en cualquier momento durante los 14 días siguientes a la infusión. Los pacientes que reciban medicación opiácea al comienzo de la diarrea pueden participar si se espera que permanezcan con dosis estables de estos medicamentos o se prevén una reducción de sus dosis o la suspensión de su uso.
12.Pacientes que planeen tomar el probiótico Saccharomyces boulardii en cualquier momento después de la infusión (día 1) y hasta que se complete el período del estudio de 12 semanas.
13.Pacientes que hayan recibido otro fármaco en investigación en los 30 días previos o que estén participando o tengan previsto participar en cualquier otro ensayo clínico durante el período del estudio de 12 semanas.
14.Pacientes que no se espere que sobrevivan durante 72 horas.
15.Pacientes con cualquier otro proceso que, en opinión del investigador, pondría en peligro la seguridad o los derechos del paciente participante en el estudio, haría improbable que el paciente completara el estudio o confundiría los resultados del estudio.

E.5 End points

E.5.1

Primary end point(s)

Proportion of patients with CDI recurrence.

Proporción de pacientes con Recurrencia de la ICD.

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 12 (Day 85±5 days)

Semana 12 (Día 85 más o menos 5 días)

E.5.2

Secondary end point(s)

Proportion of patients with global cure.

Proporción de pacientes con cura global

E.5.2.1

Timepoint(s) of evaluation of this end point

número de pacientes de la población FAS que logren curación clínica del episodio de ICD inicial Y no sufran recurrencia de la ICD hasta la semana 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

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

Yes

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

Yes

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

adaptive design allows for discontinuation of suboptimal treatment arm(s)

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

Australia

Austria

Belgium

Brazil

Canada

Chile

Colombia

Czech Republic

Denmark

Germany

India

Israel

Italy

Mexico

New Zealand

Portugal

Puerto Rico

South Africa

Spain

United Kingdom

United States

E.8.7

Trial has a data monitoring committee

Yes

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

LPLV

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:

800

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

800

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

patient or legal representative can provide written informed consent

Pacientes o representante legal que pueda firmar el consentimiento informado.

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

581

F.4.2.2

In the whole clinical trial

1600

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)

Not applicable

No aplica

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

2012-01-27

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-01-12

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2014-12-09

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Orphan Designation Number:
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