Clinical Trials Register

Summary
EudraCT Number:	2019-003108-10
Sponsor's Protocol Code Number:	GOING
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2019-11-06
Trial 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

2019-003108-10

A.3

Full title of the trial

The GOING Study: Regorafenib followed by Nivolumab in patients with Hepatocellular Carcinoma progressing under sorafenib

Estudio GOING: Regorafenib seguido del Nivolumab en pacientes con progresión de la enfermedad tratados con sorafenib

A.3.1

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

Regorafenib followed by Nivolumab in patients with Hepatocellular Carcinoma progressing under sorafenib

Regorafenib seguido del Nivolumab en pacientes con progresión de la enfermedad tratados con sorafenib

A.4.1

Sponsor's protocol code number

GOING

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	Fundació Clinic per a la Recerca Biomèdica
B.1.3.4	Country	Spain
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	BAYER
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	APICES SOLUCIONES S.L.
B.5.2	Functional name of contact point	Clinical Operations department
B.5.3	Address:
B.5.3.1	Street Address	Avenida Antonio Lopez 16 1A
B.5.3.2	Town/ city	Pinto
B.5.3.3	Post code	28320
B.5.3.4	Country	Spain
B.5.4	Telephone number	+34918166804
B.5.5	Fax number	+34918169172
B.5.6	E-mail	ana.moreno@apices.es

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	SITVARGA
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	REGORAFENIB
D.3.2	Product code	REGORAFENIB
D.3.4	Pharmaceutical form	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	REGORAFENIB
D.3.9.1	CAS number	755037-03-7
D.3.9.2	Current sponsor code	REGORAFENIB
D.3.9.3	Other descriptive name	REGORAFENIB
D.3.9.4	EV Substance Code	SUB73090
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	40
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	Yes
D.2.1.1.1	Trade name	OPDIVO
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	NIVOLUMAB
D.3.2	Product code	NIVOLUMAB
D.3.4	Pharmaceutical form	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	NIVOLUMAB
D.3.9.2	Current sponsor code	NIVOLUMAB
D.3.9.3	Other descriptive name	NIVOLUMAB
D.3.9.4	EV Substance Code	SUB122750
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	40
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.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	Yes
D.2.1.1.1	Trade name	OPDIVO
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	NIVOLUMAB
D.3.2	Product code	NIVOLUMAB
D.3.4	Pharmaceutical form	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	NIVOLUMAB
D.3.9.2	Current sponsor code	NIVOLUMAB
D.3.9.3	Other descriptive name	NIVOLUMAB
D.3.9.4	EV Substance Code	SUB122750
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	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Hepatocellular carcinoma

Carcinoma hepatocelular

E.1.1.1

Medical condition in easily understood language

Hepatocellular carcinoma

Carcinoma hepatocelular

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	20.0
E.1.2	Level	PT
E.1.2	Classification code	10073071
E.1.2	Term	Hepatocellular carcinoma
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

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate the safety of regorafenib in combination with Nivolumab.

Evaluar el perfil de seguridad de regorafenib en combinacion con nivolumab

E.2.2

Secondary objectives of the trial

Time to progression (TTP)
Pattern of progression under early phase of regorafenib and under the combination of regorafenib plus nivolumab
Overall survival (OS)
Post-progression survival
Rate of patients who develop new extra-hepatic spread Objective response rate (ORR)

Tiempo hasta progresión (TTP)
Patrón de progresión durante la fase temprana con regorafenib y durante la fase de combinacion con regorafenib y nivolumab
Supervivencia global
Supervivencia tras progresión
Tasa de pacientes que desarrollan una metástasis extrahepática nueva
Tasa de respuesta objetiva

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male or female subjects 18 years of age or older.
2. Heptatocellular carcinoma (HCC) diagnosed according to American Association for the Study of Liver Diseases (AASLD) guideline.
3. Presence of a naïve target lesion.
4. Adequate liver function: albumin > 2.8 g/dL; total bilirubin < 3 mg/dL; alanine and aspartate aminotransferases < 5 times the upper limit of the normal range, and Child-Pugh score <7 points.
5. Performance status 0-1
6. Controlled arterial hypertension and/or stable peripheral vascular disease
7. Adequate hematologic profile: platelet count > 60x109/L; haemoglobin > 8.5g/dL; and prothrombin time > 50%.
8. Adequate renal function: serum creatinine < 1.5 times the upper limit of the normal range.
9. All but first-line-related dermatologic adverse events must be grade I according to Common Terminology Criteria for Adverse Events (CTCAE) v.5.0. Early dermatologic adverse events related to sorafenib must be resolved before starting regorafenib.
10. Radiological tumor progression to first-line treatment within the 2 months of inclusion in the study.

1. Mujeres y hombres de 18 años o mayores
2. Carcinoma Hepatocelular (HCC) diagnosticado según las guías de la Asociación Americana para el Estudio de la Enfermedad Hepática (AASLD).
3. Presencia de una lesión diana inicial.
4. Función hepática adecuada: albúmina > 2,8 g/dL; bilirrubina total < 3 mg/dL; alanina y aspartato aminotransferasas < 5 veces al límite superior de normalidad, y puntuación Child-Pugh < 7puntos.
5. Estado funcional 0-1.
6. Hipertensión arterial controlada y/o enfermedad vascular periférica estable.
7. Perfil hematológico adecuado: recuento de plaquetas > 60x109/L; hemoglobina > 8,5 g/dL; y tiempo de protrombina > 50%
8. Función renal adecuada: creatinina sérica < 1,5 veces el límite superior de normalidad.
9. Todos los acontecimientos adversos salvo los dermatológicos deben ser de grado I según CTCAE v 5.0. Los acontecimientos adversos dermatológicos tempranos relacionados con sorafenib deben haberse resuelto antes de comenzar el tratamiento con regorafenib.
10. Progresión tumoral radiológica al primer tratamiento durante los dos meses previos a la inclusión en el estudio.

E.4

Principal exclusion criteria

1. Myocardial infarction in the last year or active ischemic heart disease
2. Acute variceal bleeding in the last month
3. Severe peripheral arterial disease
4. Cardiac arrhythmia under treatment with drugs different from beta-blockers or digoxin
5. Uncontrolled ascites
6. Encephalopathy
7. Unfeasibility to fulfill the follow-up Schedule.
8. Co-infection with hepatitis B (HBV) and C (HCV) as evidenced by detectable HBV surface antigen or HBV DNA and HCV RNA or Hepatitis D infection in subjects with HBV.
9. Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, prostate cancer without evidence of PSA progression or carcinoma in situ such as the following: gastric, prostate, cervix, colon, melanoma, or breast.
10. Subjects with any active autoimmune disease or history of known or suspected autoimmune disease except for subjects with vitiligo, resolved childhood asthma/atopic, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
11. Positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
12. Known active drug or alcohol abuse
13. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody (or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways);
14. Prior organ allograft or allogeneic bone marrow transplantation
15. All but dermatologic toxicities attributed to first-line treatment must have resolved to Grade 1 (NCI CTCAE version 5) or baseline before administration of study drug. Subjects with toxicities attributed to first-line treatment therapy that are not expected to resolve and result in long-lasting sequelad are not permitted. Neuropathy must have resolved to Grade 2 (NCI CTCAE version 5). Dermatologic toxicities must be resolved.
16. Active bacterial or fungal infections requiring systemic treatment within 7 days.
17. Use of other investigational drugs (drugs not marketed for any indication) within 28 days or at least 5 half-lives (whichever is longer) before study drug administration.
18. Known or underlying medical conditions that, in the Investigator’s opinion, would make the administration of the study drug hazardous to the subjects or obscure the interpretation of toxicity determination or adverse events.
19. Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
20. Laboratory evidence of any underlying medical conditions that, in the Investigator’s opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity determination or adverse events
21. History of severe hypersensitivity reactions to other monoclonal antibodies.
22. History of allergy to study drug components.
23. Women who are pregnant or breastfeeding.
24. Women with a positive pregnancy test at enrollment or prior to administration of study medication.
25. Prisoners or subjects who are involuntarily incarcerated.
26. Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness (e.g. infectious disease)
27. Inability to comply with restrictions and prohibited activities/treatments

1. Infarto de miocardio en el último año o cardiopatía isquémica.
2. Sangrado de varices agudo en el último mes.
3. Enfermedad arterial periférica severa.
4. Arritmia cardiaca tratada con fármacos distintos a beta bloqueantes o digoxina.
5. Ascitis no controlada.
6. Encefalopatía
7. Incapacidad para cumplir el esquema de seguimiento.
8. Co-infección con hepatitis B (VHB) y C (VHC) evidenciada por la presencia del antígeno de superficie del VHB o DNA de VHB y RNA de VHC o infección con hepatitis D en sujetos con VHB.
9. Carcinoma previo activo en los últimos 3 años excepto para cánceres localizados curables que hayan sido aparentemente curados, como cáncer de piel de células basales o escamosas, cáncer de próstata sin evidencia de incremento de PSA o carcinoma in situ gástrico, prostático, cervical, colónico, melanómico o mamario.
10. Sujetos con cualquier enfermedad autoinmune activa o historial de sospecha de enfermedad autoinmune o conocida excepto para pacientes con vitíligo, asma infantil/atópico resuelto, diabetes mellitus tipo 1, hipotiroidismo residual debido a enfermedad autoinmune que solo requiera restitución hormonal, psoriasis que no requiera tratamiento sistémico, o condiciones que no se espera que recurran en la ausencia de un desencadenante externo.
11. Resultado positivo para el virus de la inmunodeficiencia humana (VIH) o síndrome de la inmunodeficiencia adquirida (SIDA) confirmado.
12. Confirmación de abuso de alcohol o de sustancias activas.
13. Tratamiento previo con un anti-PD-1, anti-PDL-1, anti-PD-L2, anti-CD137, o anticuerpo anti-CTLA-4 (o cualquier otro anticuerpo o fármaco con diana específica coestimulante de células T o cascadas de control).
14. Trasplante previo autólogo o de médula ósea alogénico.
15. Todas las toxicidades atribuidas a sorafenib excepto las dermatológicas deben haberse resuelto a Grado 1 (NCI-CTCAE versión 5) o a estado basal antes de la administración del fármaco del estudio. Los sujetos con toxicidades atribuidas a tratamiento con sorafenib que no se espera su resolución y acaben en secuelas a largo a plazo pueden participar en el estudio. La neuropatía debe haberse resuelto a Grado 2 (NCI CTCAE versión 5). Las toxicidades dermatológicas deben resolverse.
16. Infección fúngica o bacteriana activa que requiera tratamiento sistémico en los 7 días previos al inicio del tratamiento.
17. Uso de otros fármacos en investigación (fármacos no comercializados para esa indicación) en los 28 días previos o al menos 5 semividas (lo que sea superior) a la entrada en el estudio.
18. Condición médica conocida o subyacente que, en opinión del investigador, aumenta la peligrosidad o interfiere en la identificación de la toxicidad de acontecimientos adversos provocados por la administración del fármaco del estudio.
19. Los pacientes con una condición que requiera tratamiento sistémico con corticoides (equivalente a > 10 mg de prednisona) u otra medicación inmunosupresora en los 14 días previos a la administración del fármaco del estudio. Los corticoides tópicos o inhalados y dosis de reemplazo adrenal equivalente a > 10 mg de prednisona serán candidatos en ausencia de enfermedad autoinmune.
20. Las evidencias de laboratorio de cualquier condición médica subyacente que, en opinión del investigador, aumenten la peligrosidad o interfieran en la identificación de la toxicidad de acontecimientos adversos provocados por la administración del fármaco del estudio.
21. Historial de reacciones de hipersensibilidad severa a otros anticuerpos monoclonales.
22. Historial de alergia a componentes del fármaco del estudio.
23. Mujeres que estén embarazadas o en periodo de lactancia.
24. Mujeres con un test de embarazo con resultado positivo al momento del reclutamiento o antes de la administración del fármaco del estudio.
25. Prisioneros o pacientes que estén encarcelados involuntariamente.
26. Pacientes que estén ingresados obligatoriamente por enfermedad física o psiquiátrica (por ejemplo enfermedad infecciosa)
27. Incapacidad de cumplir las restricciones y tratamientos/actividades prohibidos.

E.5 End points

E.5.1

Primary end point(s)

Rate and type of AEs leading to treatment discontinuation
Rate and type of AEs
Rated and type of Serious AEs (SAEs)
Rate of related-AE
Rate of death.

Tasa y tipo de Acontecimientos Adversos que provocan discontinuación del tratamiento
Tasa y tipo de Acontecimientos Adversos
Tasa y tipo de Acontecimientos Adversos Graves
Tasa de AA relacionados
Tasa de Muertes

E.5.1.1

Timepoint(s) of evaluation of this end point

During treatment and 30 days after the last dose.

Durante el tratamiento y hasta 30 días posteriores a la última dosis.

E.5.2

Secondary end point(s)

Time to progression
Pattern of progression under early phase of regorafenib and under the combination of regorafenib plus nivolumab
Overall survival
Post-progression survival
Rate of patients who develop new extra-hepatic spread Objective Rate Response (ORR)

Tiempo hasta progresión
Patrón de progresión durante la fase temprana con regoafenib y durante la fase combinación de regorafenib con nivolumab
Supervivencia global
Supervivencia posterior a progresión
Tasa de pacientes que desarrollan una nueva metástasis extra-hepática
Tasa de respuesta objetiva

E.5.2.1

Timepoint(s) of evaluation of this end point

During treatment and follow-up period

Durante el tratamiento y durante el periodo de seguimiento

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

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.8.3

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

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

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

LVLS

UVUP

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)

None

Ninguno

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

2020-01-14

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-12-12

P. End of Trial
P.	End of Trial Status	Ongoing

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