Clinical Trials Register

Summary
EudraCT Number:	2016-002190-35
Sponsor's Protocol Code Number:	20150288
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:	2016-10-10
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

2016-002190-35

A.3

Full title of the trial

A Phase 2 Open-label Study Investigating the Safety and Efficacy of Blinatumomab After Frontline R-Chemotherapy in Adult Subjects With Newly Diagnosed High-risk Diffuse Large B-Cell Lymphoma (DLBCL)

Estudio de fase II abierto que investiga la seguridad y la eficacia de blinatumomab después de quimioterapia-R de primera línea en sujetos adultos con diagnóstico reciente de linfoma B difuso de células grandes (DLBCL) de alto riesgo

A.3.1

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

Clinical phase 2 study to investigate the safety and efficacy of Blinatumomab in adult subjects with newly diagnosed high-risk diffuse large B-cell lymphoma (DLBCL) after treatment with standard of care R-Chemotherapy.

Estudio clínico de fase II que investiga la seguridad y la eficacia de blinatumomab en pacientes adultos con diagnóstico reciente de linfoma B difuso de células grandes (DLBCL) de alto riesgo después de quimioterapia-R de primera línea.

A.4.1

Sponsor's protocol code number

20150288

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT03023878

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	Amgen 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	Amgen 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	Amgen (EUROPE) GmbH
B.5.2	Functional name of contact point	Medical Information
B.5.3	Address:
B.5.3.1	Street Address	Dammstrasse 23, P.O. Box 1557
B.5.3.2	Town/ city	Zug
B.5.3.3	Post code	CH-6301
B.5.3.4	Country	Switzerland
B.5.6	E-mail	MedinfoInternational@amgen.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Blincyto
D.2.1.1.2	Name of the Marketing Authorisation holder	Amgen Europe B.V.
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Blinatumomab
D.3.2	Product code	AMG 103, MT103
D.3.4	Pharmaceutical form	Powder for concentrate for 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.3.8	INN - Proposed INN	Blinatumomab
D.3.9.1	CAS number	853426-35-4
D.3.9.2	Current sponsor code	AMG 103
D.3.9.4	EV Substance Code	SUB35403
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	38.5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Yes
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

High-risk Diffuse Large B-Cell Lymphoma (DLBCL)

linfoma B difuso de células grandes (DLBCL) de alto riesgo

E.1.1.1

Medical condition in easily understood language

Rapidly progressing lymph gland cancer

rápida progresión del cáncer de ganglios linfáticos

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.0
E.1.2	Level	PT
E.1.2	Classification code	10012818
E.1.2	Term	Diffuse large B-cell lymphoma
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

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

To evaluate the safety of blinatumomab administered after frontline R-chemotherapy in newly diagnosed subjects with high-risk DLBCL.

Evaluar la seguridad de blinatumomab administrado después de quimioterapia-R de primera línea en sujetos con diagnóstico reciente de DLBCL de alto riesgo.

E.2.2

Secondary objectives of the trial

- To estimate the efficacy of blinatumomab administered after frontline R-chemotherapy in newly diagnosed subjects with high-risk DLBCL.
- To characterize the pharmacokinetic (PK) parameters of blinatumomab administered to subjects after frontline standard of care (SOC) ritixumab (R)-chemotherapy in newly diagnosed subjects with high risk DLBCL.

-Estimar la eficacia de blinatumomab administrado después de quimioterapia-R de primera línea en sujetos con diagnóstico reciente de DLBCL de alto riesgo.
-Describir la farmacocinética (PK) de blinatumomab administrado en sujetos después de SOC con quimioterapia y rituximab (R) de primera línea en sujetos con diagnóstico reciente de DLBCL de alto riesgo.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Part 1:
1. Subject has provided informed consent prior to initiation of any study-specific activities/procedures
2. Age ≥ 18 at time of informed consent
3. Subject must have untreated and histologically proven high-risk DLBCL defined by at least one of the following:
• IPI 3 to 5
• Double-hit or higher double protein expression
4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
5. Subject meets the criteria per investigator's institution to receive SOC R-chemotherapy (ie, R-CHOP [14 or 21] or R-DA-EPOCH/R-CHOEP) of 6 cycles. Subjects may be enrolled on study prior to cycle 1 or cycle 2
6. Adequate organ and bone marrow function determined within 14 days prior to enrollment defined as follows:
Hematological:
• Absolute neutrophil count (ANC) ≥ 1.0 x 1000000000/L
• platelet count ≥ 75 x 1000000000/L
• Hemoglobin ≥ 8g/dL
Renal:
• creatinine clearance ≥ 50 mL/min Cockcroft-Gault equation
Hepatic:
• Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) < 3X upper limit of normal (ULN)
• Total bilirubin < 2X ULN (unless Gilbert's Disease or if liver involvement with lymphoma)
Part 2:
7. Subject must have completed 6 cycles of R-chemotherapy and achieved CR, PR or stable disease by PET/CT performed 3 weeks (± 3 days) after cycle 6 of SOC R-chemotherapy.
Note: Subjects with PD are not eligible for treatment with blinatumomab and will end the study.

Parte 1:
El sujeto ha proporcionado su consentimiento informado antes de iniciar cualquier procedimiento/actividad específico del estudio.
Edad ≥ 18 años en el momento del consentimiento informado.
El sujeto debe presentar DLBCL no tratado y de alto riesgo demostrado histológicamente, definido por al menos uno de los siguientes puntos:
• IPI entre 3 y 5 (consulte el apéndice D).
• Expresión doble o mayor de proteínas y/o doble hit.
Estado funcional ECOG (Eastern Cooperative Oncology Group) ≤ 2.
El sujeto cumple los criterios del centro investigador para recibir 6 ciclos de SOC con quimioterapia-R (es decir, R-CHOP [14 o 21] o R-DA-EPOCH/R-CHOEP). Los sujetos pueden incluirse en el estudio antes del ciclo 1 o el ciclo 2.
Función orgánica y de médula ósea adecuada determinada durante los 14 días previos a la inclusión, definida como:
Hematológica:
• Recuento absoluto de neutrófilos (RAN) ≥ 1,0 x 109/L.
• Recuento plaquetario ≥ 75 x 109/L.
• Hemoglobina ≥ 8g/dL
Renal:
• Aclaramiento de creatinina ≥ 50 mL/min según la ecuación de Cockcroft y Gault.
Hepática:
• Aspartato aminotransferasa (AST) y alanina aminotransferasa (ALT) < 3 x el límite superior de la normalidad (LSN).
• Bilirrubina total < 2 x LSN (excepto en caso de enfermedad de Gilbert o afectación hepática por el linfoma).
Parte 2:
El sujeto debe haber completado 6 ciclos de quimioterapia-R y haber alcanzado RC, RP o enfermedad estable según PET/TC realizada 3 semanas (± 3 días) después del ciclo 6 de SOC con quimioterapia-R.
Nota: los sujetos con EP no son elegibles para recibir tratamiento con blinatumomab y terminarán el estudio.

E.4

Principal exclusion criteria

Part 1:
1. Clinically relevant central nervous system (CNS) pathology requiring treatment such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, and psychosis
2. Evidence of CNS involvement with DLBCL at disease evaluation obtained prior to starting blinatumomab
3. Current autoimmune disease or history of autoimmune disease with potential of CNS involvement
4. Subject has active infection requiring systemic therapy
5. Prior anti-CD19 therapies
6. Known infection with human immunodeficiency virus or chronic infection with hepatitis B virus (hepatitis B surface antigen positive) or hepatitis C virus (anti-hepatitis C virus positive)
7. History of other malignancy within the past 3 years with the following exceptions:
• Malignancy treated with curative intent and with no known active disease present for ≥ 3 years before enrollment and felt to be at low risk for recurrence by the treating physician
• Adequately treated non-melanoma skin cancer or lentigo malignancy without evidence of disease
• Adequately treated cervical carcinoma in situ without evidence of disease
• Adequately treated breast ductal carcinoma in situ without evidence of disease
• Prostatic intraepithelial neoplasia without evidence of prostate cancer
• Adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ
8. Subject has known hypersensitivity to immunoglobulins or any of the products or components to be administered during dosing.
9. Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject’s and investigator’s knowledge.
10. History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
11. Females who are pregnant or breastfeeding or planning to become pregnant or breastfeed while receiving blinatumomab and for an additional 48 hours after the last treatment dose of blinatumomab. (Females of child bearing potential should only be included after a negative highly sensitive urine or serum pregnancy test.)
12. Females of childbearing potential unwilling to use an effective method of contraception while receiving blinatumomab and for an additional 48 hours after last dose of blinatumomab.
Note: The pregnancy, breastfeeding and contraceptive requirements are specific to blinatumomab. The investigator is responsible for providing the subject (male and female) with pregnancy and breastfeeding (female only) avoidance requirements for other medications (eg, SOC R-chemotherapy) given during the study.
13. Currently receiving treatment in another investigational device or drug study or less than 30 days since ending treatment on another investigational device or drug study. Other investigational procedures while participating in this study are excluded.
Part 2:
14. Any clinically significant change in the Part 1 eligibility criteria during the run-in period
15. Subject has a clinically significant laboratory abnormality during run-in period which in the opinion of the investigator poses a safety risk, will prevent the subject from completing the study, or will interfere with the interpretation of the study results during the run-in period.

parte 1:
Patología del sistema nervioso central (SNC) clínicamente relevante que necesite tratamiento como epilepsia, convulsiones, paresia, afasia, infarto cerebral, lesiones cerebrales graves, demencia, enfermedad de Parkinson, enfermedad del cerebelo, síndrome orgánico cerebral o psicosis.
Evidencia de afectación del SNC por el DLBCL obtenido en la evaluación de la enfermedad antes de iniciar blinatumomab.
Enfermedad autoinmune actual o antecedentes de enfermedad autoinmune con posible afectación del SNC.
El sujeto presenta una infección activa que requiere tratamiento sistémico.
Tratamientos previos anti-CD19.
Infección conocida por el virus de la inmunodeficiencia humana o infección crónica por el virus de la hepatitis B (positivo para antígeno de superficie de la hepatitis B) o por el virus de la hepatitis C (anti-VHC positivo).
Antecedentes de otros tumores malignos en los últimos 3 años, con las excepciones siguientes:
• Tumor maligno tratado con intención curativa y sin presencia de enfermedad activa confirmada durante ≥ 3 años antes de la inclusión y que el médico encargado del tratamiento considere de bajo riesgo de recurrencia.
• Cáncer de piel no melanomatoso o lentigo maligno tratados adecuadamente sin evidencia de enfermedad.
• Carcinoma cervicouterino in situ tratado adecuadamente sin evidencia de enfermedad.
• Carcinoma ductal de mama in situ tratado adecuadamente sin evidencia de enfermedad.
• Neoplasia intraepitelial prostática sin evidencia de cáncer de próstata.
• Carcinoma urotelial papilar no invasivo tratado adecuadamente o carcinoma in situ.
El sujeto presenta hipersensibilidad conocida a las inmunoglobulinas o a alguno de los productos o componentes que se administrarán durante la dosificación.
Según informan el sujeto y el investigador, es posible que el sujeto no esté disponible para completar todas las visitas o procedimientos del estudio requeridos por el protocolo y/o cumplir todos los procedimientos requeridos por el estudio.
Antecedentes o evidencia de cualquier otro trastorno, condición o enfermedad clínicamente significativos (excepto los indicados anteriormente) que, en opinión del investigador o del médico de Amgen, si se le consulta, pudieran suponer un riesgo para la seguridad del sujeto o interferir en la evaluación, los procedimientos o la realización del estudio.
Mujeres embarazadas o que den el pecho o que planeen quedarse embarazadas o dar el pecho mientras reciben blinatumomab y durante 48 horas adicionales después de la última dosis del tratamiento con blinatumomab. (Las mujeres en edad fértil solo deben incluirse después de un resultado negativo en una prueba de embarazo en suero u orina altamente sensible.)
Mujeres en edad fértil y que no quieran utilizar un método anticonceptivo eficaz mientras reciben blinatumomab y durante 48 horas adicionales después de la última dosis de blinatumomab.
Nota: los requisitos sobre embarazo, lactancia y anticonceptivos son específicos para blinatumomab. El investigador es responsable de informar al sujeto (hombres y mujeres) de los requisitos para evitar el embarazo y la lactancia (solo mujeres) para otros medicamentos (p. ej., SOC con quimioterapia-R) administrados durante el estudio.
Estar recibiendo tratamiento en otro estudio de un fármaco o dispositivo en investigación o haber transcurrido menos de 30 días desde el fin del tratamiento en otro estudio de un fármaco o dispositivo en investigación. Están excluidos otros procedimientos experimentales durante la participación en este estudio.
parte 2:
Cualquier cambio clínicamente significativo en los criterios de elegibilidad de la parte 1 durante el período de preinclusión.
El sujeto tiene una anomalía analítica clínicamente significativa durante el período de preinclusión que, en opinión del investigador, supondrá un riesgo de seguridad e impedirá que el sujeto complete el estudio o interferirá en la interpretación de los resultados del estudio durante el período de preinclusión.

E.5 End points

E.5.1

Primary end point(s)

Overall incidence and severity of treatment-emergent adverse events occurring during the blinatumomab treatment period graded by investigators according to Common Toxicology Criteria for Adverse Events (CTCAE) version 4.0 and characterized as related or unrelated to study drug (blinatumomab)

incidencia global y gravedad de los acontecimientos adversos que aparecen durante el tratamiento y se producen durante el período de tratamiento con blinatumomab clasificados por los investigadores de acuerdo con la versión 4.0 de los Criterios toxicológicos comunes para los acontecimientos adversos (CTCAE) y caracterizados como relacionados o no relacionados con el fármaco del estudio (blinatumomab).

E.5.1.1

Timepoint(s) of evaluation of this end point

3 months, 6 months, 9 months and 1 year from the first dose of blinatumomab

3, 6, 9 meses y 1 año desde la primera dosis de blinatumomab

E.5.2

Secondary end point(s)

• ORR expressed as the proportion of subjects achieving CR and partial response (PR). Responses will be determined by central radiographic assessment using the Lugano Classification
• Duration of response
• CR rate
• OS from first dose of blinatumomab
• PFS at 1 year from first dose of blinatumomab
• Hematopoietic stem cell transplantation (HSCT) rate
• Blinatumomab PK parameters

• TRO expresada como la proporción de sujetos que alcanzan la RC y la respuesta parcial (RP). Las respuestas se determinarán mediante la evaluación radiográfica central con el uso de la clasificación de Lugano.
• Duración de la respuesta.
• Tasa de RC.
• SG desde la primera dosis de blinatumomab.
• SLP al cabo de 1 año desde la primera dosis de blinatumomab.
• Tasa de trasplante de células progenitoras hematopoyéticas (TCPH).
• Parámetros PK de blinatumomab.

E.5.2.1

Timepoint(s) of evaluation of this end point

3 months, 6 months, 9 months and 1 year from the first dose of blinatumomab

3, 6, 9 meses y 1 año desde la primera dosis de blinatumomab

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

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

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)

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

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

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

Primary Completion: the time when the last subject is assessed or
receives an intervention for the purposes of final collection of data for
the primary analysis (ie, completion of the safety follow-up visit).

End of Trial: the time when the last subject is assessed or receives an
intervention for evaluation in the study (ie, completion of the long-term
follow-up period).

Finalización primaria: Momento en el que el último sujeto es evaluado o recibe una intervención a efectos de recolectar los datos finales para el análisis primario (p. ej, finalización de visita de seguimiento de seguridad).

Fin de ensayo: Momento en el que el último sujeto es evaluado o recibe una intervención a evaluar en el estudio (p.ej, finalización del periodo de seguimiento a largo plazo).

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

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)

Subject will continue to have their SOC treatment from their treating physician and hospital

El paciente continuará recibiendo sus tratamientos estándar asignados por parte de su médico prescriptor y el hospital.

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

2017-01-11

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-01-10

P. End of Trial
P.	End of Trial Status	Completed

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IMP with orphan designation in the indication
Orphan Designation Number:
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