Clinical Trials Register

Summary
EudraCT Number:	2015-002731-17
Sponsor's Protocol Code Number:	GS-US-339-1562
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:	2015-12-10
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

2015-002731-17

A.3

Full title of the trial

A Phase 1b-2, Open-Label, Dose Escalation and Expansion Study Evaluating the Safety and Efficacy of Entospletinib (ENTO) combined with Vincristine (VCR) and VCR-based Combination Chemotherapy in Adult Subjects with Non-Hodgkin Lymphoma (NHL)

Estudio en fase 1b-2, abierto, de aumento escalonado y expansión de dosis para evaluar la eficacia y la seguridad de entospletinib (ENTO) en combinación con vincristina (VCR) y quimioterapia combinada basada en VCR en pacientes adultos con linfoma no Hodgkin (NHL)

A.3.1

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

A Clinical Study to investigate the Safety and Efficacy of Entospletinib (GS-9973) in combination with standard of care in adult subjects with Non-Hodgkin Lymphoma (NHL).

Estudio clínico para investigar la seguridad y eficacia de Entospletinib (GS-9973) en combinación con el tratamiento estándar en sujetos adultos con linfoma no Hodgkin (LNH).

A.4.1

Sponsor's protocol code number

GS-US-339-1562

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT02568683

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	Gilead Sciences, 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	Gilead Sciences, 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	Gilead Sciences International Ltd
B.5.2	Functional name of contact point	Clinical Trials Mailbox
B.5.3	Address:
B.5.3.1	Street Address	Flowers Building, Granta Park
B.5.3.2	Town/ city	Abington, Cambridge
B.5.3.3	Post code	CB21 6GT
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	+34913789830
B.5.6	E-mail	clinical.trials@gilead.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	GS-9973
D.3.4	Pharmaceutical form	Film-coated 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	Entospletinib
D.3.9.3	Other descriptive name	ENTOSPLETINIB
D.3.9.4	EV Substance Code	SUB178740
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	100
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.2	Product code	GS-9973
D.3.4	Pharmaceutical form	Film-coated 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	Entospletinib
D.3.9.3	Other descriptive name	ENTOSPLETINIB
D.3.9.4	EV Substance Code	SUB178740
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	200
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: 3
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	Vincristine Sulphate
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	Vincristine
D.3.4	Pharmaceutical form	Solution for injection/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.3.8	INN - Proposed INN	Vincristine Sulphate
D.3.9.1	CAS number	57-22-77
D.3.9.3	Other descriptive name	VINCRISTINE SULFATE
D.3.9.4	EV Substance Code	SUB05101MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Relapsed or refractory Non-Hodgkin Lymphoma and relapsed or refractory Diffuse Large B-cell Lymphoma.

Linfoma no Hodgkin recidivante o resistente y Linfoma difuso de linfocitos B grandes recidivante o resistente.

E.1.1.1

Medical condition in easily understood language

Non-Hodgkin Lymphoma and Diffuse Large B-cell Lymphoma

Linfoma no Hodgkin y Linfoma difuso de células B grandes

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

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 evaluate the safety of Entospletinib (ENTO) with vincristine (VCR) in subjects with relapsed or refractory NHL

Evaluar la seguridad de entospletinib (ENTO) con vincristina (VCR) en pacientes con LNH recidivante o resistente

E.2.2

Secondary objectives of the trial

?The safety and efficacy of ENTO with vincristine (VCR) in subjects with relapsed or refractory NHL.
?Attain the minimally effective or the recommended phase 2 expansion dose of ENTO in combination with VCR in adult subjects with relapsed or refractory NHL.
?To evaluate the safety and therapeutic response of ENTO when administered in combination with VCR in adult subjects with relapsed or refractory DLBCL, also when administered in combination with chemotherapy regimen R-CHOP and when administered in combination with chemotherapy regimen dose-adjusted R-EPOCH in treatment naïve adult subjects with DLBCL.

?Evaluar la seguridad de entospletinib (ENTO) con vincristina (VCR) en pacientes con LNH recidivante o resistente
?Determinar la dosis mínima eficaz o la dosis de expansión de fase II recomendada de ENTO en combinación con VCR en pacientes adultos con LNH recidivante o resistente
?Evaluar la seguridad y la la respuesta terapéutica de ENTO cuando se administra en combinación con VCR en pacientes adultos con DLBCL recidivante o resistente , también cuando se administra en combinación con la pauta de quimioterapia R-CHOP y cuando se administra en combinación con la pauta de quimioterapia R-ECHOP con ajuste de dosis, en pacientes adultos con DLBCL que no hayan recibido tratamiento previamente

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1) Subjects ? 18 years of age
2) Measurable disease by computed tomograph (CT)/ and/or positron-emission tomography CT (PET-CT)
3) A) Phase 1b Dose Escalation Stage: Confirmed Diagnosis of relapsed or refractory Non-Hodgkin Lymphoma (NHL) treated with rituximab and one additional combination chemotherapy (or stem cell transplant) requiring treatment in the opinion of the treating physician
B) Phase 2 Dose Expansion Cohorts:
i) Relapsed or refractory de novo DLBCL for Dose Expansion Cohort A
ii) Treatment-naïve de novo DLBCL for Dose Expansion Cohorts B and C
4) Eastern Cooperative Oncology Group (ECOG) performance status ? 2 or Karnofsky performance status ? 70
5) Adequate organ function defined by the screening laboratory inclusion listed below and Left Ventricular Ejection Fraction (LVEF) ? 45% confirmed by ECHO or MUGA

1) Pacientes ? 18 años de edad
2) Enfermedad cuantificable mediante tomografía computerizada (TC) y/o tomografía por emisión de positrones TC (TEP-TC)
3) A) Fase Ib - Etapa de aumento escalonado de la dosis: Diagnóstico confirmado de linfoma no Hodgkin (LNH) recidivante o resistente, tratado con rituximab y una quimioterapia combinada adicional (o trasplante de células madre) que requiera tratamiento en opinión del médico responsable.
B) Fase II - Cohortes de expansión de la dosis
i) DLBCL de novo recidivante o resistente para la Cohorte A de expansión de la dosis
ii) DLBCL de novo que no haya recibido tratamiento para las Cohortes B y C de expansión de la dosis
4) Situación funcional según ECOG (Grupo Oncológico Cooperativo de la Costa Este) ? 2 o situación funcional ? 70 para la escala Karnofsky.
5) Funcionamiento satisfactorio de los órganos, definido por la inclusión del laboratorio de selección que se menciona a continuación y por una fracción de eyección del ventrículo izquierdo (FEVI) ? 45 % confirmada mediante ECO o VRN

E.4

Principal exclusion criteria

1) Dose Expansion phase (Cohorts A ? C): Diagnosis of lymphoma histologies other than DLBCL
2) Diagnosis of Primary Mediastinal Large B-cell Lymphoma
3) A life threatening illness, medical condition or organ system dysfunction which, in the investigator?s opinion, could compromise the subject?s safety or interfere with the absorption or metabolism of ENTO
4) Active or symptomatic CNS disease or epidural involvement
5) Uncontrolled intercurrent illness including, but not limited to, unstable angina pectoris or psychiatric illness/social situations that would limit compliance with study requirements
6) Current/ongoing neuropathy (sensory or motor) Grade > 1 or any history of Grade ? 3 neuropathy with prior VCR or chemotherapy exposure (documentation by history is adequate to exclude)
7) Contraindication to receive VCR or any planned protocol-specified chemotherapy
8) Eligible for autologous stem cell transplant
9) History of myelodysplastic syndrome, allogeneic stem cell or solid organ transplantation
10) History of any other non-lymphoid malignancy except for the following: adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy or requiring only hormonal therapy and with normal prostate specific antigen for ? 1 year prior to the start of study drug, or any other cancer that has been in complete remission without treatment for ? 5 years prior to enrollment

1) Fase de expansión de la dosis (Cohortes A ? C): diagnóstico de histologías de linfoma diferentes de DLBCL
2) Diagnóstico de linfoma de linfocitos B grandes mediastínico primario
3) Una enfermedad, afección o disfunción orgánica potencialmente mortal que, en opinión del investigador, pueda afectar a la seguridad del paciente o interferir con la absorción o el metabolismo de ENTO.
4) Enfermedad del SNC o afectación epidural activa o sintomática.
5) Afección intercurrente no controlada incluyendo, entre otras, angina de pecho inestable o enfermedad psiquiátrica/situaciones sociales que puedan limitar el cumplimiento de los requisitos del estudio

6) Neuropatía (sensorial o motora) actual/en curso de grado >1 o antecedentes de neuropatía de grado ? 3 con exposición previa a vincristina o quimioterapia (la documentación de antecedentes es suficiente para la exclusión)
7) Contraindicación para recibir vincristina o cualquier quimioterapia prevista que se especifique en el protocolo
8) Apto para trasplante autólogo de células madre
9) Antecedentes de síndrome mielodisplásico, trasplante alogénico de células madre o de vísceras macizas.

10)Antecedentes de cualquier otra neoplasia no linfoide, excepto en los casos siguientes: carcinoma cutáneo basocelular o de células escamosas tratado a nivel local de manera satisfactoria, carcinoma de cuello uterino en estadio 0, cáncer de vejiga superficial, cáncer de próstata asintomático sin metástasis confirmada y sin necesidad de tratamiento o que requiere solamente tratamiento hormonal y que presenta un antígeno específico de próstata normal durante ? 1 año antes del comienzo del tratamiento con el fármaco del estudio, o bien cualquier otro tipo de cáncer que haya permanecido en remisión total sin tratamiento durante ? 5 años antes de la inscripción.

E.5 End points

E.5.1

Primary end point(s)

Occurrence of adverse events and laboratory abnormalities defined as DLTs for ENTO in combination with VCR in subjects in the dose escalation stage with relapsed or refractory NHL

Aparición de acontecimientos adversos y anomalías analíticas definidas como TLD para ENTO en combinación con VCR, en pacientes en la etapa de aumento escalonado de la dosis con LNH recidivante o resistente.

E.5.1.1

Timepoint(s) of evaluation of this end point

1. For dose escalation stage, incidence of adverse events defined as dose limiting toxicities (DLTs) for ENTO in combination with VCR in participants with relapsed or refractory NHL
[Time Frame: Up to 28 days]
2. For dose escalation stage, incidence of laboratory abnormalities defined as dose-limiting toxicities (DLTs) for ENTO in combination with VCR in participants with relapsed or refractory NHL
[Time Frame: Up to 28 days]

1. Aparición de acontecimientos adversos definidos como TLD para ENTO con VCR, en pacientes en la etapa de aumento escalonado de la dosis con LNH recidivante o resistente
[Plazo: Hasta 28 días]
2. Aparición de anomalías analíticas definidas como TLD para ENTO con VCR, en pacientes en la etapa de aumento escalonado de la dosis con LNH recidivante o resistente
[Plazo: Hasta 28 días]

E.5.2

Secondary end point(s)

Safety:

1 .Occurrence of adverse events and laboratory abnormalities not defined as DLTs for ENTO with VCR in subjects in the dose escalation stage with relapsed or refractory NHL

2. Occurrence of adverse events and laboratory abnormalities for ENTO with VCR in subjects of Cohort A in dose expansion stage with relapsed or refractory DLBCL

3.Occurrence of adverse events and laboratory abnormalities for ENTO with VCR-based combination chemotherapy in subjects of Cohort B and Cohort C in dose expansion stage with treatment naïve DLBCL

Efficacy:

4.Objective response rate (ORR) will be determined from the subjects? best response during therapy of ENTO with VCR and VCR-based combination chemotherapy and will include complete response (CR) or partial response (PR)

5. Progression free survival (PFS) will be defined as the interval from the first dose of ENTO to the earlier of the first documentation of definitive disease progression or death from any cause

6. Overall survival (OS) will be defined as the interval from the start of study treatment to death from any cause.

7. Duration of response (DOR) will be defined as time from the first response (CR or PR) is achieved until the earlier of the first documentation of definitive disease progression or death from any cause

8. Time to response (TTR) will be defined as time from the first dose of ENTO to the first time the response (CR or PR) is achieved

Exposure:
9. Drug administration and duration of exposure of study treatment

Seguridad terapéutica:
? Aparición de acontecimientos adversos y anomalías analíticas no definidas como TLD para ENTO con VCR, en pacientes en la etapa de aumento escalonado de la dosis con LNH recidivante o resistente
? Aparición de acontecimientos adversos y anomalías analíticas para ENTO con VCR en pacientes de la Cohorte A en la etapa de expansión de la dosis con DLBCL recidivante o resistente
? Aparición de acontecimientos adversos y anomalías analíticas para ENTO con quimioterapia combinada basada en VCR en pacientes de la Cohorte B y la Cohorte C en la etapa de expansión de la dosis con DLBCL que no hayan recibido tratamiento
Eficacia:
? La tasa de respuesta objetiva (TRO) se determinará a partir de la mejor respuesta de los pacientes durante el tratamiento de ENTO con VCR y quimioterapia combinada basada en VCR e incluirá la respuesta completa (RC) o la respuesta parcial (RP)
? La supervivencia sin progresión (SSP) se definirá como el intervalo desde la primera dosis de ENTO hasta la confirmación primera o más temprana de progresión definitiva de la enfermedad o muerte por cualquier causa.
? La supervivencia total (ST) se definirá como el intervalo desde el inicio del tratamiento del estudio hasta el fallecimiento por cualquier causa.
?La duración de la respuesta (DDR) se definirá como el tiempo desde que se logra la primera respuesta (RC o RP) hasta la confirmación primera o más temprana de progresión definitiva de la enfermedad o muerte por cualquier causa.
? El tiempo hasta la respuesta (THR) se definirá como el tiempo desde la primera dosis de ENTO hasta la primera vez que se logre una respuesta (RC o RP).
Exposición:
? Administración del fármaco y duración de la exposición al tratamiento del estudio

E.5.2.1

Timepoint(s) of evaluation of this end point

1.[Time Frame: Up to 6 months plus 30 days]
2. [Time Frame: Up to 6 months plus 30 days]
3.[Time Frame: Up to 6 months plus 30 days]
4. [Time Frame: Up to 6 months plus 5 years]
5. [Time Frame: Up to 6 months plus 5 years]
6. [Time Frame: Up to 6 months plus 5 years]
7. [Time Frame: Up to 6 months plus 5 years]
8. [Time Frame: Up to 6 months plus 5 years]
9. [Time Frame: Up to 6 months]
10. [Time Frame: Up to 6 months]

1. [Plazo: Hasta 6 meses más 30 días]
2. [Plazo: Hasta 6 meses más 30 días]
3. [Plazo: Hasta 6 meses más 30 días]
4. [Plazo: Hasta 6 meses más 5 años]
5. [Plazo: Hasta 6 meses más 5 años]
6. [Plazo: Hasta 6 meses más 5 años]
7. [Plazo: Hasta 6 meses más 5 años]
8. [Plazo: Hasta 6 meses más 5 años]
9. [Plazo: Hasta 6 meses]
10. [Plazo: Hasta 6 meses]

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

Yes

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

Yes

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Dose Escalation and Dose Expansion study

Estudio de aumento escalonado y expansión de dosis

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

Yes

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

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

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

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

France

Germany

Hungary

Italy

Spain

United Kingdom

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

End of study will be defined when the last patient reaches the last scheduled follow-up timepoint, is lost to follow-up, withdraws from the study, dies, or the time at which the Sponsor closes the study.

Fin de estudio se define cuando el último paciente llegue al último punto de seguimiento programado, si se pierde el seguimiento, se retire del estudio, muere, o en el momento en que el patrocinador finalice el 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

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:

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

F.4.2.2

In the whole clinical trial

124

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 participation, long term care for the participant will remain the responsibility of their primary treating physicians.

Después de que un paciente haya completado / terminado su participación en el estudio, el cuidado a largo plazo para el paciente seguirá siendo responsabilidad de sus médicos de atención primaria.

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

2016-02-24

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-02-10

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2017-06-22

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