Clinical Trials Register

Summary
EudraCT Number:	2022-004154-63
Sponsor's Protocol Code Number:	VESPA
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:	2023-01-31
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

2022-004154-63

A.3

Full title of the trial

Randomized phase 2 study of Valproic acid combinEd with Simvastatin and gemcitabine/nab-paclitaxel-based regimens in untreated metastatic Pancreatic Adenocarcinoma patients (The VESPA trial)

Estudio aleatorizado de fase 2 de la combinación de ácido valproico con simvastatina en combinación con regímenes quimioterapéuticos a base de gemcitabina/nab-paclitaxel para el tratamiento de primera línea de pacientes con adenocarcinoma pancreática metastática (Estudio VESPA)

A.3.1

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

Study of Valproic acid combinEd with Simvastatin and gemcitabine/nab-paclitaxel-based regimens in untreated metastatic Pancreatic Adenocarcinoma patients (The VESPA trial)

Estudio del ácido valproico combinado con simvastatina y regímenes basados en gemcitabina/nab-paclitaxel en pacientes con adenocarcinoma pancreático metastásico no tratados (ensayo VESPA).

A.3.2

Name or abbreviated title of the trial where available

VESPA

A.4.1

Sponsor's protocol code number

VESPA

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	ISTITUTO NAZIONALE TUMORI - IRCCS FONDAZIONE PASCALE
B.1.3.4	Country	Italy
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	Ministero della Salute (progetto RF-2021-12371995)
B.4.2	Country	Italy
B.4.1	Name of organisation providing support	Remedi4All EU project (Project number: 101057442; HORIZON-HLTH-2021-DISEASE-04-02)
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Clinical Research Technology S.r.l.
B.5.2	Functional name of contact point	Clinical Operations
B.5.3	Address:
B.5.3.1	Street Address	Piazza Nicola Amore, 10
B.5.3.2	Town/ city	Napoli
B.5.3.3	Post code	80138
B.5.3.4	Country	Italy
B.5.4	Telephone number	3908119572570
B.5.5	Fax number	390897724155
B.5.6	E-mail	vespa@cr-technology.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	DEPAKIN - CHRONO 300 MG COMPRESSE A RILASCIO PROLUNGATO BLISTER DA 30 COMPRESSE
D.2.1.1.2	Name of the Marketing Authorisation holder	SANOFI-AVENTIS FRANCE S.A.
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	DEPAKIN CHRONO 300 mg
D.3.2	Product code	[Acido valproico]
D.3.4	Pharmaceutical form	Prolonged-release 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	ACIDO VALPROICO
D.3.9.1	CAS number	99-66-1
D.3.9.2	Current sponsor code	VPA
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	up to
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	Yes
D.2.1.1.1	Trade name	DEPAKIN - CHRONO 500 MG COMPRESSE A RILASCIO PROLUNGATO BLISTER DA 30 COMPRESSE
D.2.1.1.2	Name of the Marketing Authorisation holder	SANOFI-AVENTIS FRANCE S.A.
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	DEPAKIN CHRONO 500 mg
D.3.2	Product code	[Acido valproico]
D.3.4	Pharmaceutical form	Prolonged-release 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	SODIO VALPROATO/ACIDO VALPROICO
D.3.9.2	Current sponsor code	VPA
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	up to
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: 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.2.1.2	Country which granted the Marketing Authorisation	Italy
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	Simvastatina
D.3.2	Product code	[Simvastatina]
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	SIMVASTATINA
D.3.9.1	CAS number	79902-63-9
D.3.9.2	Current sponsor code	SIM
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	20
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

Metastatic Pancreatic Adenocarcinoma

Adenocarcinoma pancreático metastásico

E.1.1.1

Medical condition in easily understood language

Metastatic pancreatic tumour

Tumor pancreático metastásico

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	LLT
E.1.2	Classification code	10033599
E.1.2	Term	Pancreatic adenocarcinoma metastatic
E.1.2	System Organ Class	100000004864

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 test whether the combination of valproic acid and simvastatin plus gemcitabine/nab-paclitaxel- based regimens (AG or PAXG) may improve the efficacy of first-line gemcitabine and nab-paclitaxel-based regimens in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC).

Comprobar si la combinación de ácido valproico y simvastatina más regímenes basados en gemcitabina/nab-paclitaxel (AG o PAXG) puede mejorar la eficacia de los regímenes de primera línea basados en gemcitabina y nab-paclitaxel en pacientes con adenocarcinoma ductal pancreático metastásico (mPDAC).

E.2.2

Secondary objectives of the trial

To explore the feasibility, the efficacy and the safety of this novel combined approach in first-line mPDAC patients and the impact on their quality of life.

Correlative studies on tumor and blood samples could identify potential biomarkers of toxicity/efficacy also adding new insight into the antitumor mechanism of VPA/SIM in combination with chemotherapy.

Explorar la viabilidad, la eficacia y la seguridad de este novedoso enfoque combinado en pacientes mPDAC de primera línea y el impacto en su calidad de vida.

Los estudios correlativos en muestras tumorales y sanguíneas podrían identificar biomarcadores potenciales de toxicidad/eficacia, añadiendo también nuevos conocimientos sobre el mecanismo antitumoral de VPA/SIM en combinación con quimioterapia.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Written informed consent to study procedures and to correlative studies.
2. Histologically or cytologically proven metastatic PDAC.
3. No prior treatments (chemotherapy, radiation or surgery) for PDAC.
4. Either sex aged = 18
5. Eastern Cooperative Oncology Group (ECOG) Performance Status =1 at study entry.
6. Imaging-documented measurable disease, according to RECIST 1.1 criteria.
7. Known dihydropyrimidine dehydrogenase (DPD) activity is mandatory for patients enrolled in PAXG scheme.
8. Adequate bone marrow haematological function: absolute neutrophil count (ANC) = 1.5 x 109/L AND platelet count = 100 x 109/L AND haemoglobin = 9 g/dL.
9. Adequate liver function: total bilirubin = 1.5 x upper limit of normal (ULN) or = 2 (in case of biliary stent) and aspartate aminotransferase (AST)/alanine aminotransferase (ALT) = 5 X ULN. Adequate renal function: serum creatinine = 1.5 mg/dL OR creatinine clearance = 60 mL/min in males and =50 mL/min in females (calculated according to Cockroft-Gault formula).

1. Consentimiento informado por escrito para los procedimientos del estudio y para los estudios correlativos.
2. PDAC metastásico demostrado histológica o citológicamente.
3. Sin tratamientos previos (quimioterapia, radioterapia o cirugía) para PDAC.
4. Cualquier sexo, edad = 18 años.
5. Estado de rendimiento del Eastern Cooperative Oncology Group (ECOG) =1 al inicio del estudio.
6. Enfermedad medible documentada por imagen, según los criterios RECIST 1.1.
7. La actividad conocida de la dihidropirimidina deshidrogenasa (DPD) es obligatoria para los pacientes incluidos en el esquema PAXG.
8. Función hematológica de la médula ósea adecuada: recuento absoluto de neutrófilos (ANC) = 1,5 x 109/L Y recuento de plaquetas = 100 x 109/L Y hemoglobina = 9 g/dL.
9. 9. Función hepática adecuada: bilirrubina total = 1,5 x límite superior de la normalidad (LSN) o = 2 (en caso de stent biliar) y aspartato aminotransferasa (AST)/alanina aminotransferasa (ALT) = 5 X ULN. Función renal adecuada: creatinina sérica = 1,5 mg/dL O aclaramiento de creatinina = 60 mL/min en varones y =50 mL/min en mujeres (calculado según la fórmula de Cockroft-Gault).

E.4

Principal exclusion criteria

1. Prior malignancy within one year. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
2. Prior chemotherapy or any other medical treatment for metastatic PDAC (previous adjuvant chemotherapy is allowed if terminated > 6 months previously).
3. Patients who have had prior treatment with an HDAC inhibitor and patients who have received compounds with HDAC inhibitor-like activity, such as valproic acid.
4. Current use of statins or fibrates or any medication for hypercholesterolemia for any time during the 3 months before the study.
5. Proven hypersensitivity to statins.
6. Major surgical intervention within 4 weeks prior to enrollment.
7. Pregnancy and breast-feeding.
8. Brain metastasis.
9. Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator’s opinion makes it undesirable for the patient to participate in the study, or which would jeopardize compliance with the protocol, or would interfere with the results of the study.
10. Patients with long QT-syndrome or QTc interval duration > 480 msec or concomitant medication with drugs prolonging QTc (see list in the appendix).
11. History of poor co-operation, non-compliance with medical treatment, unreliability or any condition that may impair the patient's understanding of the Informed consent form.
12. Participation in any interventional drug or medical device study within 30 days prior to treatment start.
13. Patients who cannot take oral medication, who require intravenous alimentation, have had prior surgical procedures affecting absorption, or have active peptic ulcer disease.
14. Sexually active males and females (of childbearing potential) unwilling to practice contraception (barrier contraceptive measure or oral contraception) during the study and until 6 months after the last trial treatment.

1. Antecedentes de neoplasia maligna en el plazo de un año. Las excepciones incluyen el carcinoma basocelular de piel o el carcinoma escamoso de piel que haya sido sometido a una terapia potencialmente curativa o el cáncer de cuello uterino in situ.
2. Quimioterapia previa o cualquier otro tratamiento médico para el PDAC metastásico (se permite la quimioterapia adyuvante previa si finalizó > 6 meses antes).
3. Pacientes que hayan recibido previamente tratamiento con un inhibidor de la HDAC y pacientes que hayan recibido compuestos con actividad similar a los inhibidores de la HDAC, como el ácido valproico.
4. Uso actual de estatinas o fibratos o cualquier medicación para la hipercolesterolemia tomada en cualquier momento durante los 3 meses anteriores al estudio.
5. Hipersensibilidad demostrada a las estatinas.
6. Cirugía mayor en las 4 semanas previas a la inscripción.
7. Embarazo y lactancia.
8. Metástasis cerebrales.
9. Evidencia de enfermedad sistémica grave o no controlada o cualquier afección concomitante que, en opinión del investigador, haga indeseable la participación del paciente en el estudio o ponga en peligro el cumplimiento del protocolo o interfiera en los resultados del estudio.
10. Pacientes con síndrome de QT largo o duración del intervalo QTc > 480 mseg o tratamiento concomitante con fármacos que prolongan el intervalo QTc (véase la lista en el Apéndice).
11. Antecedentes de escasa cooperación, incumplimiento del tratamiento médico, falta de fiabilidad o cualquier condición que pueda dificultar la comprensión del formulario de consentimiento informado por parte del paciente.
12. Participación en cualquier estudio de intervención con fármacos o dispositivos médicos en los 30 días anteriores al inicio del tratamiento.
13. Pacientes que no pueden tomar fármacos por vía oral, requieren alimentación intravenosa, han sufrido una intervención quirúrgica previa que afecta a la absorción o tienen una úlcera péptica activa.
14. Hombres y mujeres sexualmente activos (en edad fértil) que no estén dispuestos a practicar la anticoncepción (medida anticonceptiva de barrera o anticoncepción oral) durante el estudio y hasta 6 meses después de la última administración del tratamiento del estudio.

E.5 End points

E.5.1

Primary end point(s)

• Progression Free Survival (PFS) between two arms

PFS is defined as the time from randomization to the first documentation of objective disease progression by RECIST 1.1 criteria, or death due to any cause, whichever occurs first.

- Supervivencia sin progresión (SLP) entre dos brazos

La SLP se define como el tiempo transcurrido desde la aleatorización hasta la primera documentación de progresión objetiva de la enfermedad según los criterios RECIST 1.1, o la muerte por cualquier causa, lo que ocurra primero.

E.5.1.1

Timepoint(s) of evaluation of this end point

PFS will be censored at the time of the last available tumor assessment documenting absence of progressive disease for patients alive at the time of analysis.

La SLP se censurará en el momento de la última evaluación tumoral disponible que documente la ausencia de enfermedad progresiva para los pacientes vivos en el momento del análisis.

E.5.2

Secondary end point(s)

To compare the two arms in terms of:
• Objective Tumor Response Rate (ORR)
• Disease Control Rate (DCR)
• Duration of Objective response (DOR)
• CA19.9 level reduction
• Overall survival (OS)
• Overall toxicity rate
• Quality of life (QoL)

Comparar los dos brazos en términos de
- Tasa de respuesta tumoral objetiva (ORR)
- Tasa de control de la enfermedad (DCR)
- Duración de la respuesta objetiva (DOR)
- Reducción del nivel de CA19,9
- Supervivencia global (SG)
- Tasa de toxicidad global
- Calidad de vida (CdV)

E.5.2.1

Timepoint(s) of evaluation of this end point

- Toxicity rate at each visit
- QoL, based on questionnaire EORTC QLQ-C30 and QLQ-PAN26 at baseline and every 8 weeks until 40 weeks after randomization, regardless of disease progression, or death
- about 6 months for other end points.

- Tasa de toxicidad en cada visita
- Calidad de vida, basada en el cuestionario EORTC QLQ-C30 y QLQ-PAN26 al inicio del estudio y cada 8 semanas hasta 40 semanas después de la aleatorización, independientemente de la progresión de la enfermedad o la muerte.
- aproximadamente 6 meses para otros criterios de valoración.

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

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

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

Yes

E.8.2.3.1

Comparator description

Estándard de tratamiento (sólo quimioterapia)

Standard of care (chemotherapy only)

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the 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

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

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

Ultima visita del último paciente

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:

200

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

120

F.4.2

For a multinational trial

F.4.2.1

In the EEA

240

F.4.2.2

In the whole clinical trial

240

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. Patients will be treated/assisted as per local clinical guidelines

Ninguno. Los pacientes serán tratados según directrices clínicas locales

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

2023-05-17

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2023-05-11

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

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